CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
Upamostat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05954286
NCT05954286Phase 2Completed
CompareCT.gov

Master Protocol for Early Treatment and Post-Exposure Prophylaxis of COVID-19 Adaptive Platform Trial PROTECT-APT 1

Henry M. Jackson Foundation for the Advancement of Military Medicine·interventional·Posted Jul 20, 2023·Updated Apr 17, 2026

In Brief

A Phase 2 clinical trial evaluating Upamostat and Placebo (PO) for SARS-CoV-2. Completed, enrolled 92 participants across 6 sites in 4 countries.

Detailed Summary

This study is an adaptive, randomized, double blind, platform trial evaluating promising investigational products (IP) for safety and efficacy as early outpatient treatment and post-exposure prophylaxis for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2
CountriesSouth Africa, Thailand, Uganda, United States
CollaboratorsJoint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies, RedHill Biopharma Limited, FHI Clinical, Inc.

Timeline

Phase 2CompletedFinished
202420252026
First PostedJul 20, 2023
Enrollment StartJan 29, 2024
Primary CompletionApr 24, 2025
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 2.9 years ago

Interventions

Upamostatdrug

Upamostat is available as a hydrogen sulphate salt (also designated as WX-671.1). WX-671.1 is a white to yellowish powder which is freely soluble in dimethyl sulfoxide and soluble in ethanol. The drug substance is very slightly soluble in water or 0.1 M HCl.

Placebo (PO)drug

Oral Capsules