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Bucillamine in Treatment of Patients With COVID-19

NCT04504734 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 713

Last updated 2023-07-07

No results posted yet for this study

Summary

This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo. This dose has now been chosen as 600 mg. The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this study. Up to 1000 patients will be enrolled in this study. Patients will participate in the study approximately 45 days.

Conditions

  • Covid19

Interventions

DRUG

Bucillamine

100mg tablets

DRUG

Placebo

100mg tablets

DRUG

Bucillamine

200mg tablets

Sponsors & Collaborators

  • Revive Therapeutics, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-27
Primary Completion
2023-06-12
Completion
2023-06-12
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

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 NCT04504734 on ClinicalTrials.gov