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

NCT04267822 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-08

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

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)

DRUG

Placebo oral tablet

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

Sponsors & Collaborators

Principal Investigators

  • PfizerCT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2023-06-30
Completion
2023-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04267822 on ClinicalTrials.gov