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RSV InfectionPhase 2REVIRAL2NCT04267822

Study of RV521 in the Treatment of Adult Subjects Who Have Undergone HCT With an URTI With RSV

A Phase 2 study testing RV521 oral tablet in people with RSV Infection and Stem Cell Transplant Complications, run by Pfizer.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RV521 is to being developed to treat RSV infection and disease in susceptible individuals at high risk for complications. This is an international, multicenter, placebo-controlled study. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
RV521 oral tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
15 Jun 2020to 31 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has undergone autologous or allogeneic HCT using any conditioning regimen within 1 year of randomization. Subjects who have undergone HCT more than 1 year before Randomization are eligible if all other inclusion/exclusion criteria are satisfied and under at least one of the following conditions:
  • Diagnosed with Chronic Graft-vs-Host Disease (GVHD), or
  • Has used systemic corticosteroids in the 30 days prior to RSV infection
  • Has moderate to severe immunocompromise, defined as a score ≥ 5 on the ISI-RSV and/or an ALC of ≤ 500 cells/ mm3
  • Documentation of positive RSV infection in the upper airway

Who cannot join

  • Use of non-marketed investigational agents within 30 days, OR use of an investigational monoclonal anti-RSV antibodies within 4 months or 5 half-lives of screening, whichever is longer, OR use of any investigational RSV vaccines after HCT.
  • Receiving a prescription, OTC, or herbal medication that is a potent inducer or inhibitor of CYP3A4, within 2 weeks of Randomization.
  • Receiving a prescription, OTC, or herbal medication that is a substrate of CYP3A4 with a narrow therapeutic index where monitoring blood levels is not possible.
  • Known chronic infection with hepatitis B, C, or HIV.
  • Is in the pre-engraftment period during RSV infection.
  • Admitted to the hospital primarily for lower respiratory tract disease of any cause as determined by the Investigator.
Show all 11Show fewer
  • Any condition requiring mechanical ventilation or vasopressor support at the time of randomization.
  • Clinically significant bacteremia or fungemia within 5 days prior to Screening that has not been adequately treated.
  • Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to Screening that has not been adequately treated.
  • Excessive nausea/vomiting at Screening or an inability to swallow capsules.
  • Elevation of hepatic enzymes or renal compromise.

About this study

Official title: Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, and Efficacy of RV521 in the Treatment of Adult Subjects Who Have Undergone Hematopoietic Cell Transplantation (HCT) With a Documented Upper Respiratory Tract Infection (URTI) With Respiratory Syncytial Virus (RSV)

RV521 is to being developed to treat RSV infection and disease in susceptible individuals at high risk for complications. This is an international, multicenter, placebo-controlled study. Eligible subjects are adults with a documented symptomatic RSV infection who have undergone HCT transplantation and are moderately to severely immunocompromised. Qualified subjects will be randomized in a 1:1 ratio to receive RV521 or placebo, twice daily for 10 days.

Read the detailed description

The purpose of this study is to compare the viral load, safety, tolerability, and clinical efficacy of RV521 compared to placebo. This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled study. Up to 200 adult subjects with a documented symptomatic RSV URTI who have undergone HCT within 1 year of randomization and who are moderately to severely immunocompromised will be randomized.

Qualified subjects will be randomized in a 1:1 ratio to receive RV521 capsules or matching placebo twice daily for 10 days. After the completion of the 10-day double-blind treatment period, subjects will be followed for an additional 28 days. Study drug may be taken on an outpatient or inpatient basis, depending on clinical status and site practices. Randomization will be stratified by type of HCT graft and ALC count. There are 9 clinic visits planned for this study.

Being tested
RV521 oral tablet, Placebo oral tablet
Keywords
RV521, lower respiratory tract complication, HCT, hematopoietic cell transplantation, LRTI, Respiratory tract infection, immunocompromise
Medical subject headings
Respiratory Syncytial Virus Infections, Respiratory Tract Infections

What participants receive

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

  • RV521 oral tabletDrug

    Also called sisunatovir

    Each RV521 dose is four 50 mg dry powder blend capsules, taken orally twice daily for 10 days (20 doses total; 80 capsules total)

  • Placebo oral tabletDrug

    Also called vehicle

    Each placebo dose is four capsules, taken orally twice daily for 10 days (20 doses total; 80 capsules total)

Study groups in NCT04267822
Study groupRoleWhat they receive
RV521 CapsulesExperimentalRV521 is formulated as a dry powder blend of RV521 drug substance with mannitol as excipient. They are a white, opaque capsule and administered orally.
Receives: Drug: RV521 oral tablet
RV521 Placebo CapsulesPlacebo comparatorRV521 placebo capsules will contain mannitol and microcrystalline cellulose only. They are a white, opaque capsule and administered orally.
Receives: Drug: Placebo oral tablet

What is being measured

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

  1. Proportion of subjects with a progression to Lower Respiratory Tract Complication (LRTC) during the study

    Progression to LRTC during the study defined as one of the following:

    • Primary LRTI caused by RSV
    • Secondary bacterial LRTI
    • LRTI caused by another pathogen
    • LRTC of unknown etiology

    Measured: Pre-dose baseline (Day 1) through Visit 8 (Day 28)

  2. Change in RSV nasal viral load (via RT-qPCR)

    RSV change measured by the time-weighted average (DAVG) viral load using RT qPCR

    Measured: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)

Secondary outcomes (24)

  1. Percent of participants who experience AEs, TEAEs, SAEs and withdrawals due to TEAEs

    Safety analyses will include a summary of AEs, including but not limited to n (%) of subjects in each treatment group and overall.

    Measured: First dose of study drug through Visit 8 (Day 28)

  2. Evaluate safety and tolerability of RV521 by assessing changes from baseline in systolic and diastolic BP (vital sign parameters)

    BP will be collected in mm Hg. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.

    Measured: Baseline through Visit 8 (Day 28)

  3. Evaluate safety and tolerability of RV521 by assessing changes from baseline in body temperature (vital sign parameters)

    Body Temperature will be collected in degrees Fahrenheit (°F) or degrees Celsius (°C). Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.

    Measured: Baseline through Visit 8 (Day 28)

  4. Evaluate safety and tolerability of RV521 by assessing changes from baseline in respiration rate (vital sign parameters)

    Respiration rate will be measured in breaths per minute. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.

    Measured: Baseline through Visit 8 (Day 28)

  5. Evaluate safety and tolerability of RV521 by assessing changes from baseline in pulse/heart rate (vital sign parameters)

    Heart rate will be measured in beats per minute. Quantitative variables will be summarized used the statistics n, mean, standard deviation, median, minimum and maximum.

    Measured: Baseline through Visit 8 (Day 28)

  6. Evaluate safety and tolerability of RV521 by assessing changes from baseline weight/BMI

    Weight and height will be collected and combined to report BMI

    Measured: Baseline through Visit 8 (Day 28)

  7. Evaluate the proportion of subjects with changes and shifts in hematology/clinical chemistry/urinalysis laboratory values (laboratory tests read by a central lab) from baseline.

    Results at each visit will be summarized using the statistics n, mean, standard deviation, median, minimum and maximum. Also, change from baseline will also be summarized by post baseline visits.

    Measured: Collected at Visit 2/Day 1 (pre-dose), Visit 4/Day 3, Visit 6/Day 14 and Visit 8/Day 28

  8. Evaluate the proportion of subjects with changes in ECG measurements and changes in clinical impression from baseline

    ECGs will be taken with a centrally supplied ECG machine and electronically transmitted to a central ECG repository. ECG will only be evaluated by the Investigator for normal, abnormal NCS and abnormal CS.

    Parameters collected will be:

    • Ventricular Heart Rate (bpm)
    • PR Interval (msec)
    • QRS Interval (msec)
    • QT Interval (msec)
    • QTcB Interval (msec)

    Results at each visit will be summarized using the statistics: n (number of observations), mean, SD, median, minimum and maximum.

    Measured: Measurements will be taken at Day 1/Visit 2 (pre-dose and at 5-hours post-dose), on Day 3/Visit 4 (at 5 hours post-dose), and at Visit 6 (Day 14)

  9. Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by RT-qPCR

    Nasal swabs will be collected for analysis of viral load and RSV F protein gene sequencing at a central laboratory. Viral load will be assessed at intervals from nasal swabs by RT-qPCR.

    Measured: Pre-dose baseline (Day 1) and every visit through Visit 8 (Day 28)

  10. Relationship between plasma exposures of RV521 and RSV viral loads measured in nasal swabs by CBIA

    Nasal swabs will be collected for analysis of viral load and RSV F protein gene sequencing at a central laboratory. Viral load will be assessed at intervals from nasal swabs by CBIA.

    Measured: Pre-dose baseline (Day 1) and every visit through Visit 8 (Day 28)

  11. Mean change in RSV viral load assessed via CBIA

    change measured by the time weighted average (DAVG) viral load using CBIA

    Measured: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)

  12. Mean change from baseline in viral RNA shedding

    RSV assessed via nasal swabs collected at each visit and analyzed at a central laboratory.

    Measured: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)

  13. Proportion of subjects who no longer shed RSV assessed by both RT-qPCR and CBIA at each timepoint

    RSV assessed via nasal swabs collected at each visit and analyzed at a central laboratory.

    Measured: Pre-dose baseline (Day 1) through study completion; up to Visit 8 (Day 28)

  14. Time to improvement in RSV-related symptoms

    Defined as all symptoms present at initiation of therapy are mild or no longer present. (absent/resolved)

    Measured: Daily from baseline (Day 1) through Visit 8 (Day 28)

  15. Time to total resolution of all RSV-related symptoms

    Defined as all symptoms are no longer present.

    Measured: Daily from baseline (Day 1) through Visit 8 (Day 28)

  16. Proportion of days with lowest daily SpO2 ≥ 90% on room air

    SpO2 measured at every visit. For subjects on oxygen or who are mechanically ventilated may have this waived.

    Measured: Daily from baseline (Day 1) through Visit 8 (Day 28)

  17. Number of days where supplementary oxygen was required

    Use of daily supplementary oxygen will be collected throughout the study.

    Measured: Baseline (Day 1) through Visit 8 (Day 28)

  18. Proportion of subjects who require hospitalization during the study

    Daily hospitalization utilization will be collected

    Measured: Baseline (Day 1) through Visit 8 (Day 28)

  19. Mean number of days of hospitalization during the study

    Daily hospitalization utilization will be collected

    Measured: Baseline (Day 1) through Visit 8 (Day 28)

  20. Proportion of subjects requiring ICU

    Daily ICU utilization will be collected

    Measured: Baseline (Day 1) through Visit 8 (Day 28)

  21. Mean number of days in ICU

    Daily ICU utilization will be collected

    Measured: Baseline (Day 1) through Visit 8 (Day 28)

  22. Proportion of subjects requiring mechanical ventilation

    Daily mechanical ventilation requirements will be collected

    Measured: Baseline (Day 1) through Visit 8 (Day 28)

  23. Number of subjects who experience death (all-cause mortality)

    Patient outcome will be followed and collected

    Measured: First dose of study drug through Visit 8 (Day 28)

  24. Number of subjects who experience death attributable to LRTC

    Patient outcome will be followed and collected

    Measured: First dose of study drug through Visit 8 (Day 28)

Timeline

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

  1. First posted13 Feb 2020
  2. Study start15 Jun 2020 (estimated)
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion31 Jul 2023 (estimated)

Why it stopped: No recruitment

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
Parallel groups
Model description
A Phase 2, international, multicenter, randomized, double-blind, placebo-controlled study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04267822
Sponsor's protocol ID
REVC006
Other IDs
C5241011
Acronym
REVIRAL2
Status last verified
May 2023
First submitted
5 Feb 2020
Last updated
8 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
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 oral tablet in people with RSV Infection and Stem Cell Transplant Complications, run by Pfizer.

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 5 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: withdrawn, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Proportion of subjects with a progression to Lower Respiratory Tract Complication (LRTC) during the study (time frame: Pre-dose baseline (Day 1) through Visit 8 (Day 28)). The study lists 2 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 NCT04267822.

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 8 May 2023.

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