SARS-CoV-2 Infection, COVID-19Phase 2NCT04405570
Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19
A Phase 2 study testing Molnupiravir 200 mg, Molnupiravir 400 mg and Molnupiravir 800 mg in people with SARS-CoV-2 Infection, COVID-19, run by Ridgeback Biotherapeutics, LP at 10 sites in United States.
Trial summary
This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 (molnupiravir) versus placebo as measured by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, COVID-19
- What is being tested?
- Molnupiravir 200 mg, Molnupiravir 400 mg and Molnupiravir 800 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Jun 2020to 21 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent prior to initiation of any study procedures.
- ≥18 years of age at Screening.
- Study treatment is expected to begin within ≤168 hours from first symptom onset.
- Ability to swallow pills.
- Documentation of confirmed active SARS-CoV-2 infection, as determined by a molecular or non-molecular ("rapid") test conducted at any clinic or laboratory that had a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent from a sample collected ≤96 hours prior to study entry.
- Was experiencing at least one of the following SARS-CoV-2 infection symptoms at the time of enrollment: fever (could be subjective including feeling feverish or having chills) OR signs/symptoms of respiratory illness (including but not limited to upper respiratory congestion, loss of sense of smell or taste, sore throat OR lower respiratory illness - cough, shortness of breath).
Show all 25Show fewer
- Agreed to not participate in another interventional clinical trial for the treatment of SARS-CoV-2 during the study period (28 days) unless hospitalized.
- Agreed to not obtain investigational medications outside of the molnupiravir study.
- Agreed to the sampling detailed in the schedule of evaluations and to comply with study requirements including contraception requirements.
- A female participant was eligible to participate if she was not pregnant or breastfeeding and at least one of the following conditions applied:
- Was not a woman of childbearing potential (WOCBP) OR
- Was a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user-dependent method in combination with a barrier method), or was abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 2 of the study protocol during the intervention period and for at least 50 days after the last dose of study intervention. The investigator evaluated the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
- A WOCBP must have had a negative highly sensitive pregnancy test (serum or urine) within 24 hours before the first dose of study intervention.
- Additional requirements for pregnancy testing during and after study intervention were provided in the study protocol.
- The investigator was responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Contraceptive use by women was to be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Given the elevated risk of venous thrombotic events in patients hospitalized with COVID-19 (Benson et al, 2020; Spratt et al, 2020), estrogen-containing contraceptives could not be started to fulfill the contraceptive requirement of this study at any time during participant's participation. If contraceptives were interrupted as standard of care management of COVID-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence was practiced for the defined period of back-up contraception per the contraceptive product labeling. After this period, contraceptive use had to adhere to the guidance in Appendix 2 of the study protocol.
- Male participants were eligible to participate if they agreed to the following during the intervention period and for at least 100 days after the last dose of study intervention:
- Refrained from donating sperm
- PLUS either:
- Were abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agreed to remain abstinent.
- OR
- Had to agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause [Appendix 2 of the study protocol]) as detailed below:
- Agreed to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who was not pregnant. Note: Men with a pregnant or breastfeeding partner had to agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
- Contraceptive use by men was to be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Need for hospitalization or immediate medical attention in the clinical opinion of the study investigator.
- Hemoglobin <10 g/dL in men and <9 g/dL in women.
- Platelet count <100,000/ µL or received a platelet transfusion within 5 days prior to enrollment.
- Was on dialysis or has an estimated glomerular filtration rate <30 mL/min/1.73 m^2
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >3x upper limit normal (ULN).
- History of or current hospitalization for COVID-19. Note: Individuals hospitalized and then discharged, even if only hospitalized for 1 day, were excluded.
Show all 14Show fewer
- History of kidney disease as evidenced by estimated creatinine clearance value <30 mL/min.
- History of significant liver disease in the opinion of the site investigator or active hepatitis B or active hepatitis C. Human immunodeficiency virus (HIV) that is advanced (CD4<200/mm^3) and/or on treatment with nucleos(t)ide analogues.
- Use of therapeutic interventions with possible anti-SARS-CoV-2 activity within 30 days prior to study entry, (e.g., remdesivir, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, and convalescent plasma), or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis.
- Receipt of a SARS-CoV-2 vaccination prior to study entry.
- Known allergy/sensitivity or any hypersensitivity to components of molnupiravir, or its formulation.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- History of recent (within the past 3 months) hemorrhagic cerebrovascular accident) or major bleed.
- Presence of a condition, that in the opinion of the investigator, would place the subject at increased risk from study participation.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
Duke University Medical Center
Durham, North Carolina, 27710
Care United Research, LLC
Forney, Texas, 75126
Indago Research and Health Center, Inc.
Hialeah, Florida, 33012
NOLA Research Works, LLC
New Orleans, Louisiana, 70115
Valley Clinical Trials, Inc.
Northridge, California, 91325
FOMAT Medical Research
Oxnard, California, 93030
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Southern California Emergency Medicine
Yucaipa, California, 92399
About this study
Official title: A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of EIDD-2801 to Eliminate SARS-CoV-2RNA Detection in Persons With COVID-19
This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 (molnupiravir) versus placebo as measured by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19.
Read the detailed description
This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of molnupiravir versus placebo as measured by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19. The study was a multicenter trial that was conducted in the United States.
In this study, 204 participants were randomized and 202 received molnupiravir or placebo orally twice a day (BID) for 5 days. The study enrolled participants in 5 parts with each part evaluating molnupiravir doses of either 200 mg BID, 400 mg BID, or 800 mg BID. Doses were chosen based on emerging virology and safety data from this and ongoing studies. New dose groups were started after the selected dose had been studied for safety in a Phase 1 study.
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Being tested
- Molnupiravir 200 mg, Molnupiravir 400 mg, Molnupiravir 800 mg, Placebo (PBO)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molnupiravir 200 mgDrug
Oral capsule of molnupiravir
Molnupiravir 400 mgDrug
Oral capsule of molnupiravir
Molnupiravir 800 mgDrug
Oral capsule of molnupiravir
Placebo (PBO)Drug
placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Molnupiravir 200 mg | Experimental | Molnupiravir 200 mg, twice daily (BID) for 5 days Receives: Drug: Molnupiravir 200 mg |
| Molnupiravir 400 mg | Experimental | Molnupiravir 400 mg, twice daily (BID) for 5 days Receives: Drug: Molnupiravir 400 mg |
| Molnupiravir 800 mg | Experimental | Molnupiravir 800 mg, twice daily (BID) for 5 days Receives: Drug: Molnupiravir 800 mg |
| Placebo (PBO) twice daily (BID) for 5 days | Placebo comparator | Not described Receives: Drug: Placebo (PBO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs
The number of participants until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test.
Non detectable defined as "a viral load below the limit of quantification
Measured: 28 days
Time to Clearance of SARS-CoV-2 in Nasopharyngeal Swabs
The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test.
Non detectable defined as "a viral load below the limit of quantification
Measured: 28 days
Number of Participants With Adverse Events (AEs) Grade 3 or Higher or Leading to Discontinuation of Study Treatment
- any AEs leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AEs (not already present at baseline), and 4) study drug-related new grade 3 or higher AEs.
Measured: 28 days
Secondary outcomes (1)
Number of Participants With Any Adverse Events (AEs), Grade 2 or Higher
Measure the safety and tolerability of EIDD-2801 by estimating the occurrence of Grade 2 or higher AE and drug related AEs.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start19 Jun 2020
- Primary completion21 Feb 2021
- Study completion21 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 Infection, COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ridgeback Biotherapeutics, LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405570
- Sponsor's protocol ID
- EIDD-2801-2003
- Status last verified
- Feb 2022
- First submitted
- 26 May 2020
- Last updated
- 16 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Mollan KR, Eron JJ, Krajewski TJ, Painter W, Duke ER, Morse CG, Goecker EA, Premkumar L, Wolfe CR, Szewczyk LJ, Alabanza PL, Loftis AJ, Degli-Angeli EJ, Brown AJ, Dragavon JA, Won JJ, Keys J, Hudgens MG, Fang L, Wohl DA, Cohen MS, Baric RS, Coombs RW, Sheahan TP, Fischer WA. Infectious Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Virus in Symptomatic Coronavirus Disease 2019 (COVID-19) Outpatients: Host, Disease, and Viral Correlates. Clin Infect Dis. 2022 Aug 24;75(1):e1028-e1036. doi: 10.1093/cid/ciab968.
PubMed 35022711Fischer W, Eron JJ, Holman W, Cohen MS, Fang L, Szewczyk LJ, Sheahan TP, Baric R, Mollan KR, Wolfe CR, Duke ER, Azizad MM, Borroto-Esoda K, Wohl DA, Loftis AJ, Alabanza P, Lipansky F, Painter WP. Molnupiravir, an Oral Antiviral Treatment for COVID-19. medRxiv [Preprint]. 2021 Jun 17:2021.06.17.21258639. doi: 10.1101/2021.06.17.21258639.
PubMed 34159342Mollan KR, Eron JJ, Krajewski TJ, Painter W, Duke ER, Morse CG, Goecker EA, Premkumar L, Wolfe CR, Szewczyk LJ, Alabanza PL, Loftis AJ, Degli-Angeli EJ, Brown AJ, Dragavon JA, Won JJ, Keys J, Hudgens MG, Fang L, Wohl DA, Cohen MS, Baric RS, Coombs RW, Sheahan TP, Fischer WA 2nd. Infectious SARS-CoV-2 Virus in Symptomatic COVID-19 Outpatients: Host, Disease, and Viral Correlates. medRxiv [Preprint]. 2021 Jun 25:2021.05.28.21258011. doi: 10.1101/2021.05.28.21258011.
PubMed 34100024Cox RM, Wolf JD, Plemper RK. Therapeutically administered ribonucleoside analogue MK-4482/EIDD-2801 blocks SARS-CoV-2 transmission in ferrets. Nat Microbiol. 2021 Jan;6(1):11-18. doi: 10.1038/s41564-020-00835-2. Epub 2020 Dec 3.
PubMed 33273742
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of EIDD-2801 to Eliminate SARS-CoV-2RNA Detection in Persons With COVID-19
- ClinicalTrials.gov ID
- NCT04405570
- Acronym / sponsor ID
- EIDD-2801-2003
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Ridgeback Biotherapeutics, LPIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 21 Feb 2021 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Posted 16 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 (molnupiravir) versus placebo as measured by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19.
Detailed description
This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of molnupiravir versus placebo as measured by SARS-CoV-2 viral RNA detection in symptomatic adult outpatients with COVID-19. The study was a multicenter trial that was conducted in the United States.
In this study, 204 participants were randomized and 202 received molnupiravir or placebo orally twice a day (BID) for 5 days. The study enrolled participants in 5 parts with each part evaluating molnupiravir doses of either 200 mg BID, 400 mg BID, or 800 mg BID. Doses were chosen based on emerging virology and safety data from this and ongoing studies. New dose groups were started after the selected dose had been studied for safety in a Phase 1 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Molnupiravir 200 mg | Experimental | Drug: Molnupiravir 200 mgMolnupiravir 200 mg, twice daily (BID) for 5 days |
| Molnupiravir 400 mg | Experimental | Drug: Molnupiravir 400 mgMolnupiravir 400 mg, twice daily (BID) for 5 days |
| Molnupiravir 800 mg | Experimental | Drug: Molnupiravir 800 mgMolnupiravir 800 mg, twice daily (BID) for 5 days |
| Placebo (PBO) twice daily (BID) for 5 days | Placebo comparator | Drug: Placebo (PBO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Able to provide informed consent prior to initiation of any study procedures.
- ≥18 years of age at Screening.
- Study treatment is expected to begin within ≤168 hours from first symptom onset.
- Ability to swallow pills.
- Documentation of confirmed active SARS-CoV-2 infection, as determined by a molecular or non-molecular ("rapid") test conducted at any clinic or laboratory that had a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent from a sample collected ≤96 hours prior to study entry.
Key exclusion criteria (14 listed)
- Need for hospitalization or immediate medical attention in the clinical opinion of the study investigator.
- Hemoglobin <10 g/dL in men and <9 g/dL in women.
- Platelet count <100,000/ µL or received a platelet transfusion within 5 days prior to enrollment.
- Was on dialysis or has an estimated glomerular filtration rate <30 mL/min/1.73 m^2
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >3x upper limit normal (ULN).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molnupiravir 200 mgOral capsule of molnupiravir | Drug | Molnupiravir 200 mg |
| Molnupiravir 400 mgOral capsule of molnupiravir | Drug | Molnupiravir 400 mg |
| Molnupiravir 800 mgOral capsule of molnupiravir | Drug | Molnupiravir 800 mg |
| Placebo (PBO)placebo oral capsule | Drug | Placebo (PBO) twice daily (BID) for 5 days |
Primary outcome
Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs
Time frame: 28 days
The number of participants until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test. Non detectable defined as "a viral load below the limit of quantification
Time to Clearance of SARS-CoV-2 in Nasopharyngeal Swabs
Time frame: 28 days
The distribution of days until first non-detectable SARS-CoV-2 in nasopharyngeal (NP) swabs will be estimated for each randomized arm (drug versus placebo), using Kaplan-Meier methods with a corresponding log-rank test. Non detectable defined as "a viral load below the limit of quantification
Number of Participants With Adverse Events (AEs) Grade 3 or Higher or Leading to Discontinuation of Study Treatment
Time frame: 28 days
1) any AEs leading to early discontinuation of blinded treatment (active or placebo), 2) study drug-related discontinuation of treatment, 3) new grade 3 or higher AEs (not already present at baseline), and 4) study drug-related new grade 3 or higher AEs.
1 secondary outcome
Number of Participants With Any Adverse Events (AEs), Grade 2 or Higher
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35022711Mollan KR, Eron JJ, Krajewski TJ, Painter W, Duke ER, Morse CG, Goecker EA, Premkumar L, Wolfe CR, Szewczyk LJ, Alabanza PL, Loftis AJ, Degli-Angeli EJ, Brown AJ, Dragavon JA, Won JJ, Keys J, Hudgens MG, Fang L, Wohl DA, Cohen MS, Baric RS, Coombs RW, Sheahan TP, Fischer WA. Infectious Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Virus in Symptomatic Coronavirus Disease 2019 (COVID-19) Outpatients: Host, Disease, and Viral Correlates. Clin Infect Dis. 2022 Aug 24;75(1):e1028-e1036. doi: 10.1093/cid/ciab968.
- Derived from this study: PubMed 34159342Fischer W, Eron JJ, Holman W, Cohen MS, Fang L, Szewczyk LJ, Sheahan TP, Baric R, Mollan KR, Wolfe CR, Duke ER, Azizad MM, Borroto-Esoda K, Wohl DA, Loftis AJ, Alabanza P, Lipansky F, Painter WP. Molnupiravir, an Oral Antiviral Treatment for COVID-19. medRxiv [Preprint]. 2021 Jun 17:2021.06.17.21258639. doi: 10.1101/2021.06.17.21258639.
- Derived from this study: PubMed 34100024Mollan KR, Eron JJ, Krajewski TJ, Painter W, Duke ER, Morse CG, Goecker EA, Premkumar L, Wolfe CR, Szewczyk LJ, Alabanza PL, Loftis AJ, Degli-Angeli EJ, Brown AJ, Dragavon JA, Won JJ, Keys J, Hudgens MG, Fang L, Wohl DA, Cohen MS, Baric RS, Coombs RW, Sheahan TP, Fischer WA 2nd. Infectious SARS-CoV-2 Virus in Symptomatic COVID-19 Outpatients: Host, Disease, and Viral Correlates. medRxiv [Preprint]. 2021 Jun 25:2021.05.28.21258011. doi: 10.1101/2021.05.28.21258011.
- Derived from this study: PubMed 33273742Cox RM, Wolf JD, Plemper RK. Therapeutically administered ribonucleoside analogue MK-4482/EIDD-2801 blocks SARS-CoV-2 transmission in ferrets. Nat Microbiol. 2021 Jan;6(1):11-18. doi: 10.1038/s41564-020-00835-2. Epub 2020 Dec 3.
- Benson et al, 2020. Society of Family Planning interim clinical recommendationsLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for SARS-CoV-2 Infection, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Molnupiravir 200 mg, Molnupiravir 400 mg and Molnupiravir 800 mg in people with SARS-CoV-2 Infection, COVID-19, run by Ridgeback Biotherapeutics, LP at 10 sites in United States.
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 25 inclusion and 14 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: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 16 Feb 2022). 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?
Number of Participants Until First Non-detectable SARS-CoV-2 in Nasopharyngeal (NP) Swabs (time frame: 28 days). The study lists 3 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 NCT04405570, which also lists 4 linked publications.
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 16 Feb 2022.