Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05954286 | PROTECT-APT 1: Early Treatment and Post-Exposure Prophylaxis of COVID-19 | PHASE2 | COMPLETED | 92 | — | — | Jan 29, 2024 | Apr 24, 2025 | Apr 17, 2026 | 6 | United States, South Africa +2 |
Defined as the number of days from randomization within a PSA to the first day the participant reports all symptoms as mild or none for at least 3 consecutive days. Symptoms will be assessed via completion of a Screening Symptom Questionnaire at Enrollment and then a Daily Follow Up Symptom Questionnaire.
| Arm | Type | Description |
|---|---|---|
| Early Treatment: Upamostat 400 mg | EXPERIMENTAL | 400 mg (2 x 200 mg) capsules administered orally once daily for 14 days |
| Early Treatment: Placebo Oral Capsule | PLACEBO_COMPARATOR | The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way. |
| Name | Type | Description |
|---|---|---|
| Upamostat | DRUG | 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 |
Population A: Symptomatic adults seeking care or testing for COVID-19 Inclusion Criteria: 1. Age ≥ 18 years 2. Positive molecular or antigen diagnostic test for SARS-CoV-2 at study enrollment or within ≤ 5 days prior to enrollment 3. Presence of two or more Screening Symptoms listed in Supplement ...