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PROTECT-APT 1: Early Treatment and Post-Exposure Prophylaxis of COVID-19

NCT05954286 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-04-17

Study results available
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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).

Conditions

Interventions

DRUG

Upamostat

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.

DRUG

Placebo (PO)

Oral Capsules

Sponsors & Collaborators

  • Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies

    collaborator OTHER_GOV

  • RedHill Biopharma Limited

    collaborator INDUSTRY

  • FHI Clinical, Inc.

    collaborator UNKNOWN

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2025-04-24
Completion
2025-04-24
FDA Drug
Yes

Countries

  • United States
  • South Africa
  • Thailand
  • Uganda

Study Locations

More Related Trials

Entities

Diseases

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 NCT05954286 on ClinicalTrials.gov