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

NCT ID: NCT04267822

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2023-07-31

Brief 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. 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.

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.

Conditions

RSV Infection; Stem Cell Transplant Complications; Lower Resp Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RV521 Capsules

RV521 is formulated as a dry powder blend of RV521 drug substance with mannitol as excipient. They are a white, opaque capsule and administered orally.

Group Type: EXPERIMENTAL

RV521 oral tablet

Intervention Type: DRUG

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

RV521 Placebo Capsules

RV521 placebo capsules will contain mannitol and microcrystalline cellulose only. They are a white, opaque capsule and administered orally.

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

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

Interventions

RV521 oral tablet

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

Intervention Type: DRUG

Placebo oral tablet

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

Intervention Type: DRUG

Other Intervention Names

sisunatovir; vehicle

Eligibility Criteria

Exclusion Criteria

1. Diagnosed with Chronic Graft-vs-Host Disease (GVHD), or

2. Has used systemic corticosteroids in the 30 days prior to RSV infection

2. Has moderate to severe immunocompromise, defined as a score ≥ 5 on the ISI-RSV and/or an ALC of ≤ 500 cells/ mm3

3. Documentation of positive RSV infection in the upper airway

1. 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.

2. Receiving a prescription, OTC, or herbal medication that is a potent inducer or inhibitor of CYP3A4, within 2 weeks of Randomization.

3. 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.

4. Known chronic infection with hepatitis B, C, or HIV.

5. Is in the pre-engraftment period during RSV infection.

6. Admitted to the hospital primarily for lower respiratory tract disease of any cause as determined by the Investigator.

7. Any condition requiring mechanical ventilation or vasopressor support at the time of randomization.

8. Clinically significant bacteremia or fungemia within 5 days prior to Screening that has not been adequately treated.

9. Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to Screening that has not been adequately treated.

10. Excessive nausea/vomiting at Screening or an inability to swallow capsules.

11. Elevation of hepatic enzymes or renal compromise.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PfizerCT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Other Identifiers

C5241011

Identifier Type: OTHER

Identifier Source: secondary_id

REVC006

Identifier Type: -

Identifier Source: org_study_id