AzTrials
AzTrials

Respiratory Syncytial Virus (RSV)Phase 2REVIRAL 1NCT04225897

A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.

A Phase 2 study testing RV521 in people with Respiratory Syncytial Virus (RSV) and Lower Resp Tract Infection, run by Pfizer at 60 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections. Read more about this study

Who is it for?
Ages 1 month to 36 months
What is being tested?
RV521
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
60 sitesin 15 countries
Study dates
13 Nov 2019to 5 Dec 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 36 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female ≥ 1 month and ≤ 36 months of age
  • Weight ≥ 3.5 kg
  • Clinical diagnosis of LRTI
  • A positive RSV diagnostic test
  • Hospitalised because of RSV LRTI
  • Symptoms of LRTI must be present for no more than 1 week (Part B) and no more than 5 days (Part C) before the Screening Visit
  • Expected to remain in hospital for a minimum of 3 days
  • The parent(s)/legal guardian(s) of the subject have provided written informed consent for the subject to participate and are able and willing to comply with the study protocol

Who cannot join

  • Premature (gestational age less than 37 weeks) AND <1 year of post-natal age
  • Known to have significant comorbidities that would limit the ability to administer study drug or evaluate the safety or clinical response to study drug.
  • Any clinically significant ECG abnormalities.
  • Known to be immunocompromised.
  • High risk of having developing asthma.
  • Suspected of having a clinically significant bacterial infection.
Show all 11Show fewer
  • History of renal failure.
  • Clinical evidence of hepatic decompensation
  • History of epilepsy or seizures, including febrile seizures
  • Allergy to test medication or constituents
  • Has received 1 or more doses of palivizumab at any time before Screening or received treatment with antiviral therapy for RSV (eg, ribavirin or intravenous [IV] immunoglobulin) within 3 months before the Screening Visit.

Trial locations and contacts

60 sites in 15 countries.

60 sites in 15 countries

Thailand10 sites

  • King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University

    Bangkok, 10330

  • QueenSirikit National Institute of Child Health {QSNICH}

    Bangkok, 10400

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkoknoi, Bangkok, 10700

  • The Pharmacy Unit Ground Floor, OPD Building Faculty of Madicine,

    Bangkoknoi, Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital,Faculty of Medicine, Chiang Mai University

    Chiang Mai, 50200

  • Chiangrai Prachanukroh Hospital

    Chiangrai, 57000

  • Faculty of Medicine, Khon Kaen University

    Khon Kaen, 40002

  • Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

    Khon Kaen, 40002

  • Chula Clinical Research Center, Faculty of Medicine

    Patumwan, Bangkok, 10330

  • Naresuan University Hospital ,Faculty of Medicine, Naresuan University

    Phitsanulok, 65000

Other trials in Thailand

Spain9 sites

  • Fundacion Hospital de Nens

    Barcelona, 08009

  • Hospital Universitario Sant Joan de Deu

    Espluges de Llobregat, Barcelona, 08950

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Clinico de San carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario de la Paz ,Pediatric Deparment

    Madrid, 28046

  • Hospital Universitario La Paz Servicio de Farmacia. Planta baja Edificio Norte

    Madrid, 28046

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Complejo Hospitalario de Santiago

    Santiago de Compostela, 15706

Other trials in Spain

Malaysia7 sites

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan, 15586

  • Hospital Sultanah Nur Zahirah

    Kuala Terengganu, Terengganu, 20400

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

  • Hospital Seri Manjung

    Parek, 32040

  • Hospital Seberang Jaya

    Seberang Jaya, Pulau Pinang, 13700

  • Hospital Sibu

    Sibu, Sarawak, 96000

  • Hospital Taiping

    Taiping, Perak, 34000

Other trials in Malaysia

Costa Rica5 sites

  • Corporacion Gihema

    San José

  • Hospital Clinica Biblica

    San José

  • Hospital Metropolitano, Sede San Jose

    San José

  • lnstituto de lnvestigacion en Ciencias Medicas(IICIMED)

    San José

  • Policlinico San Bosco, Consultorio de Pediatria, Dr. Arturo Solis Moya

    San José

Other trials in Costa Rica

Taiwan4 sites

  • Hsinchu Mackay Memorial Hospital

    Hsinchu, 30071

  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    Hualien City, 970

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Chi Mei Medical Center

    Tainan, 710

Other trials in Taiwan

United Kingdom4 sites

  • Alder Hey Children's NHS Foundation Trust Institute in the Park

    Liverpool, L 12 2AP

  • Guy's and St Thomas' NHS Foundation Trust Evelina London Children's Hospital Westminster

    London, SE1 7EH

  • Imperial College Healthcare NHS Trust St Mary's Hospital

    London, W2 1NY

  • University Hospital Southampton NHS Foundation Trust NIHR Clinical Research Facility ,Mailpoint 218,

    Southampton, SO16 6YD

Other trials in United Kingdom

Argentina3 sites

  • Hospital Interzonal General de Agudos "Dr. José Penna"

    Bahía Blanca, Buenos Aires, B8001DDU

  • Hospital Italiano Regional Del Sur

    Bahía Blanca, Buenos Aires, B8001HXM

  • Hospital General de Ninos Pedro de Elizalde

    Buenos Aires, Buenos Aires F.D., C1270AAN

Other trials in Argentina

Hungary3 sites

  • Semmelweis Egyetem 11.sz. Gyermeklinika

    Budapest, 1094

  • Eszak-Kozep-budai Centrum,Uj Szent Janos Korhaz es Szakrendelo,Gyermekosztaly

    Budapest, 1125

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

Other trials in Hungary

Israel3 sites

  • Soroka University Medical Center

    Beersheba, 84417

  • Rambam Health Care Campus

    Haifa, 3109601

  • Schneider Children's Medical Center of Israel

    Petach Tikava, 49202

Other trials in Israel

Panama3 sites

  • Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"

    Panama City

  • Hospital del Nino Dr. Jose Renan Esquivel

    Panama City

  • Hospital Materno Infantil Jose Domingo de Obaldia

    Panama City

Other trials in Panama

Poland3 sites

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30-663

  • lnstytut Centrum Zdrowia Matki Polki Klinika Pediatrii, Immunologii i Nefrologii

    Lodz, 93-338

  • Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie Oddzial Kliniczny Pediatrii

    Warsaw, 02-091

Other trials in Poland

Chile2 sites

  • Hospital Base San Jose Osorno

    Osorno, Los Lagos Region, 5311523

  • Hospital de Ninos Dr. Roberto del Rio

    Santiago, Santiago Metropolitan, 8380418

Other trials in Chile

South Korea2 sites

  • Seoul National University Children's Hospital

    Seoul, 03080

  • Department of Pediatrics, SoonchunHyang University Seoul Hospital

    Seoul, 04401

Other trials in South Korea

Canada1 site

  • Hospital de ninos "Ricardo Gutierrez"

    Calgary, Alberta, T2J 7E1

Other trials in Canada

New Zealand1 site

  • Capital and Coast DHB, Wellington Hospital

    Riddiford Street, Wellington Region, 6021

Other trials in New Zealand

About this study

Official title: A Phase 2 Open-Label Study in Infants With REspiratory Syncytial VIRus Lower RespirAtory Tract Infection, Followed by a DoubLe-blind, Placebocontrolled Part, to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of RV521 (REVIRAL 1)

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections. This study will assess sisunatovir as compared to placebo in infants aged 1 month to 36 months who are hospitalized with RSV lower respiratory tract infection (LRTI). A placebo looks like the study medicine but does not contain any active medicine in it.

This study will be conducted in 3 parts:

Read more

In Part A participants aged 6 months to 3 years will be given a single dose of 2.5 mg/kg of sisunatovir in Cohort 1. In Cohort 2, participants age 1 month to 6 months will receive a single dose of 2 mg/kg of sisunatovir only after the completion of Cohort 1. 12-24 participants will be enrolled in Part A In Part B participants age 1 month to 36 months will receive sisunatovir or placebo dosed every 12 hours for 5 days. Doses for part B will be determined after the completion of Part A. 24-40 participants will be enrolled in Part B.

The dose regimen for Part C will be determined after the completion of Part B. Approximately 120 participants age 1 month to 36 months will receive either sisunatovir or placebo.

To participate in this study participants must meet the following criteria:

  1. Age 1 month to 36 months
  2. Weight ≥ 3.5 kg
  3. Diagnosis of LRTI
  4. Diagnosis of RSV
  5. Hospitalization due to RSV LRTI
Read the detailed description

This is a multicentre, 3-part study to evaluate safety, tolerability, PK, PD, and antiviral effect of single and multiple dosing of RV521 in infants hospitalised due to RSV LRTI.

The clinical study consists of 3 parts, the third part (Part C) is optional:

  • Part A is an open-label, multicentre, single dose study in infants hospitalised with RSV LRTI (Cohorts 1 \& 2)
  • Part B is a randomised, double-blind, placebo-controlled, multicentre multiple dose study in infants hospitalised with RSV LRTI (Cohorts 3, 4 \& 5)
  • Part C is a randomised 1:1, double-blind, placebo-controlled, multicentre, multiple-dose study in infants hospitalised with RSV LRTI I The number of subjects enrolled in Parts A and B of the study will depend on the safety and PK data from the group of subjects enrolled in specified age cohorts and the subsequent recommendation of the Data Safety Monitoring Committee (DSMC).

The DSMC may recommend a dose adjustment (either a reduction or an escalation) and/or regimen adjustment (Part B only) for subsequent subjects because of the observation of an unexpected safety/tolerability profile and/or differences between the observed and predicted exposure resulting from a specified dose of RV521.

Being tested
RV521, Placebo
Keywords
RV521, Pediatrics, Children, LRTI, Wheezing, Rhinitis, Cough, sisunatovir
Medical subject headings
Respiratory Sounds, Rhinitis, Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RV521Drug

    Also called sisunatovir

    RV521 is an RSV F protein inhibitor administered orally

  • PlaceboDrug

    vehicle administered orally

Study groups in NCT04225897
Study groupRoleWhat they receive
RV521Experimentalsisunatovir is formulated as a dry powder blend of RV521 drug substance with mannitol as excipient. The RV521 dry powder blend will be supplied in capsules containing 10, 20, or 50 mg RV521. The Investigational Medicinal Product (IMP) will be dispersed in a defined volume of suspending diluent prior to oral administration on a mg/kg basis. Instructions for opening the capsule(s) and dispersing the contents in a fixed volume of suspending diluent prior to administration will be provided in the Pharmacy Manual. The proposed dosing regimen for Part A is a single open label dose of RV521. Part B and C is RV521 or placebo administered BID, 12 hours apart, for a period of 5 consecutive days with a total of 10 doses. However, this is subject to the recommendation of the DSMC.
Receives: Drug: RV521
PlaceboPlacebo comparatorThe placebo capsules administered in Part B and C will contain mannitol and microcrystalline cellulose (vehicle). The placebo dry powder will be dispersed in suspending diluent and given orally BID. Instructions for opening the capsule(s) and dispersing the contents in a fixed volume of suspending diluent prior to administration will be provided in the Pharmacy Manual.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP

    An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event.

    Measured: From start of IMP on Day 1 up to Day 7

  2. Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP

    An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event.

    Measured: From start of IMP on Day 1 up to Day 12

  3. Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline

    Physical examination included general appearance; head, eyes, ears, nose and throat (HEENT); dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

    Measured: Baseline (pre-dose on Day 1)

  4. Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose

    Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

    Measured: Anytime between 18 to 24 hours post-dose on Day 1

  5. Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose

    Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

    Measured: At 48 hours post-dose on Day 1

  6. Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline

    Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

    Measured: Baseline (pre-dose on Day 1)

  7. Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10

    Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.

    Measured: Anytime between 40 to 48 hours post-dose 10 on Day 5

  8. Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

    Measured: Baseline (pre-dose on Day 1)

  9. Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

    Measured: Anytime between 4 to 5 hours post-dose on Day 1

  10. Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

    Measured: At 12 hours post-dose on Day 1

  11. Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-Dose

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

    Measured: Anytime between 18 to 24 hours post-dose on Day 1

  12. Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

    Measured: 48 hours post-dose on Day 1

  13. Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

    Measured: Baseline (pre-dose on Day 1)

  14. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

    Measured: Anytime between 4 to 5 hours post-dose 1 (Day 1)

  15. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 2= assessment prior to receiving dose 2 of IMP on Day 1.

    Measured: Pre-dose 2 (Day 1)

  16. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 3= assessment prior to receiving dose 3 of IMP on Day 2.

    Measured: Pre-dose 3 (Day 2)

  17. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 4= assessment prior to receiving dose 4 of IMP on Day 2.

    Measured: Pre-dose 4 (Day 2)

  18. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 5= assessment prior to receiving dose 5 of IMP on Day 3.

    Measured: Pre-dose 5 (Day 3)

  19. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 6= assessment prior to receiving dose 6 of IMP on Day 3.

    Measured: Pre-dose 6 (Day 3)

  20. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

    Measured: Anytime between 4 to 5 hours post-dose 6 (Day 3)

  21. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 7= assessment prior to receiving dose 7 of IMP on Day 4.

    Measured: Pre-dose 7 (Day 4)

  22. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 8= assessment prior to receiving dose 8 of IMP on Day 4.

    Measured: Pre-dose 8 (Day 4)

  23. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 9= assessment prior to receiving dose 9 of IMP on Day 5.

    Measured: Pre-dose 9 (Day 5)

  24. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 10= assessment prior to receiving dose 10 of IMP on Day 5.

    Measured: Pre-dose 10 (Day 5)

  25. Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.

    Measured: Anytime between 40 to 48 hours post-dose 10 on Day 5

  26. Part A: Number of Participants With Abnormal Hematology Results at Baseline

    Hematology parameters included basophils, eosinophils, mean cell hemoglobin concentration (MCHC), mean cell hemoglobin (MCH), mean cell volume (MCV), red blood cell count (RBC), hematocrit (HCT), hemoglobin (Hb), white blood cell count (WBC), lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

    Measured: Baseline (pre-dose on Day 1)

  27. Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose

    Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

    Measured: At 48 hours post-dose on Day 1

  28. Part B: Number of Participants With Abnormal Hematology Results at Baseline

    Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

    Measured: Baseline (pre-dose on Day 1)

  29. Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10

    Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.

    Measured: Anytime between 40 to 48 hours post-dose 10 on Day 5

  30. Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline

    Clinical chemistry parameters included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, gamma glutamyltransferase (GGT), glucose, lactate dehydrogenase (LDH), potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

    Measured: Baseline (pre-dose on Day 1)

  31. Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose

    Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

    Measured: At 48 hours post-dose on Day 1

  32. Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline

    Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

    Measured: Baseline (pre-dose on Day 1)

  33. Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10

    Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.

    Measured: Anytime between 40 to 48 hours post-dose 10 on Day 5

  34. Part A: Number of Participants With Abnormal Urinalysis Results at Baseline

    Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per high power field [hpf]), erythrocytes (0 to 2 per hpf), granular casts (0 per low power field [lpf]), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).

    Measured: Baseline (pre-dose on Day 1)

  35. Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose

    Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and potential of hydrogen (pH) (5 to 8).

    Measured: At 48 hours post-dose on Day 1

  36. Part B: Number of Participants With Abnormal Urinalysis Results at Baseline

    Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).

    Measured: Baseline (pre-dose on Day 1)

  37. Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10

    Following urine parameters were analysed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).

    Measured: Anytime between 40 to 48 hours post-dose 10 on Day 5

  38. Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QT interval corrected by Bazzett's formula (QTcB) interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: Baseline (pre-dose on Day 1)

  39. Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: Anytime between 4 to 5 hours post-dose on Day 1

  40. Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-dose

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: Anytime between 18 to 24 hours post-dose on Day 1

  41. Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: 48 hours post-dose on Day 1

  42. Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: Baseline (pre-dose on Day 1)

  43. Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: Anytime between 4 to 5 hours post-dose 1 on Day 1

  44. Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: Pre-dose 3 (Day 2)

  45. Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: Pre-dose 5 (Day 3)

  46. Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: Anytime between 4 to 5 hours post-dose 6 (Day 3)

  47. Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: Pre-dose 8 (Day 4)

  48. Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: Pre-dose 10 (Day 5)

  49. Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10

    A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.

    Measured: Anytime between 40 to 48 hours post-dose 10 on Day 5

Secondary outcomes (29)

  1. Part A: Time to Maximum Plasma Concentration (Tmax)

    No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the Pharmacokinetic (PK) population.

    Measured: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

  2. Part B: Time to Maximum Plasma Concentration (Tmax)

    No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

    Measured: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  3. Part A: Maximum Observed Plasma Concentration (Cmax)

    No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

    Measured: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

  4. Part B: Maximum Observed Plasma Concentration (Cmax)

    No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

    Measured: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  5. Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)

    AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

    Measured: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours post-dose on Day 1

  6. Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)

    AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

    Measured: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  7. Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])

    Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

    Measured: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

  8. Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])

    Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

    Measured: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  9. Part A: Terminal Half-life (t1/2)

    T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

    Measured: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

  10. Part B: Terminal Half-life (t1/2)

    T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

    Measured: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  11. Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)

    AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

    Measured: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

  12. Part B: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)

    AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

    Measured: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  13. Part A: Trough Concentration at the End of First Dosing Interval (C12)

    Measured: At 12 hours post-dose on Day 1

  14. Part B: Trough Concentration at the End of Dose 6 (C12)

    Measured: At 12 hours post-dose 6

  15. Part A: Predicted Plasma Clearance

    Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

    Measured: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

  16. Part B: Predicted Plasma Clearance

    Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

    Measured: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  17. Part A: Apparent Volume of Distribution of the Drug After Extravascular Administration

    Apparent volume of distribution was estimated as Dose/Kel*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.

    Measured: Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1

  18. Part B: Apparent Volume of Distribution of the Drug After Extravascular Administration

    Apparent volume of distribution was estimated as Dose/Kel*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

    Measured: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  19. Part B: Accumulation Ratio

    Accumulation ratio was calculated as ratio of the area under the curve (AUC) during a single dosing interval under steady state conditions to the AUC during a dosing interval after one singe dose. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.

    Measured: Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  20. Part B: Percentage Fluctuation

    Percentage fluctuation was calculated as 100*(Cmax-Cmin)/Cavg, where Cmin=minimum plasma concentration and Cmax measured over dosing interval.

    Measured: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  21. Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau)

    AUC(0 to tau) was determined using the linear trapezoidal method.

    Measured: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  22. Part B: Average Plasma Concentration Over Dosing Interval (Cavg)

    Cavg was estimated as AUC(0 to tau)/tau, where tau=dosing interval (12 hours).

    Measured: Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)

  23. Part B: Minimum Observed Plasma Concentration

    Measured: Day 3 Dose 6 (pre-dose)

  24. Part B: Plasma Trough Concentration

    Measured: Day 3 Dose 6 (pre-dose)

  25. Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)

    Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects analysis of covariance (ANCOVA) model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group >=1 month to <6 months.

    Measured: Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1

  26. Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA)

    Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects ANCOVA model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group >=1 month to <6 months.

    Measured: Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1

  27. Part B: Time to Resolution of RSV-Related Signs and Symptoms

    Time to resolution was calculated for RSV-related signs and symptoms that were present at study start and was defined as the time of randomization to the time that RSV-related signs and symptoms were absent.

    Measured: Up to Day 12

  28. Part B: Time to Improvement in RSV-Related Signs and Symptoms

    Time to improvement was calculated for RSV-related signs and symptoms that were classified as moderate or severe during the course of the study and was defined as the time from randomization to the time that RSV-related signs and symptoms were mild or absent.

    Measured: Up to Day 12

  29. Part B: RSV Clinical Scoring System Scores

    RSV clinical score was a composite score for infants with RSV infection >= 1 month of age based on 4 items (respiratory rate, wheezing, retraction of respiratory muscles and general condition). Score for each item ranged from 0 to 3 where 0=none/normal and 3=severe. Total score was calculated as sum of individual items and ranged from 0 to 12, where higher score indicated severe disease. RSV symptoms were graded as mild: score <=5, moderate: score > 5 but < 9 and severe: score >=9.

    Measured: Baseline (pre-dose 1 on Day 1), pre-dose 3, pre-dose 5, pre-dose 7, pre-dose 9, anytime between 40 to 48 hours post-dose 10 on Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start13 Nov 2019
  3. Primary completion5 Dec 2022
  4. Study completion5 Dec 2022

Why it stopped: Part A and Part B were completed but Pfizer terminated Part C due to strategic consideration. There were no safety concerns in the decision to stop Part C and no changes to the risk-benefit for participants who received RV521 in the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
This is a multicentre, 3-part study to evaluate safety, tolerability, PK, PD, and antiviral effect of single and multiple dosing of RV521 in infants hospitalised due to RSV LRTI. Due to the adaptive study design, the number of enrolled subjects may vary depending on the obtained PK and safety profiles. The clinical study consists of 3 parts: * Part A is an open-label, multicentre, single dose study in infants hospitalised with RSV LRTI (Cohorts 1 \& 2) * Part B is a randomised, double-blind, placebo-controlled, multicentre multiple dose study in infants hospitalised with RSV LRTI (Cohorts 3, 4 \& 5) * Part C is a randomised 1:1, double-blind, placebo-controlled, multicentre, multiple-dose study in infants hospitalised with RSV LRTI
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04225897
Sponsor's protocol ID
REVC003
Other IDs
C5241003
Acronym
REVIRAL 1
Status last verified
Aug 2024
First submitted
11 Dec 2019
Last updated
23 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RV521 in people with Respiratory Syncytial Virus (RSV) and Lower Resp Tract Infection, run by Pfizer at 60 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Thailand, Spain, Malaysia, Costa Rica, Taiwan and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP (time frame: From start of IMP on Day 1 up to Day 7). The study lists 49 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04225897.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in