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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05799495 | A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized | PHASE2 | COMPLETED | 240 | — | — | May 23, 2023 | Oct 11, 2023 | Oct 9, 2024 | 53 | United States |
Change from baseline in SARS-CoV-2 RNA level at Day 5 was analyzed using Mixed Effects Repeated Measures (MMRM) model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (\<=3 versus \[vs.\] \>3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4\*log10 copies/milliliter, missing, or not detected.
| Arm | Type | Description |
|---|---|---|
| Arm 1: low dose | EXPERIMENTAL | - |
| Arm 2: medium dose | EXPERIMENTAL | - |
| Arm 3: high dose | EXPERIMENTAL | - |
| Arm 4: Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-07817883 | DRUG | Arm 1: low dose Arm 2: medium dose Arm 3: high dose |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Participants ≥18 to \<65 years of age at the time of the Screening Visit. * WOCBP may be enrolled. * All fertile participants must agree to use a highly effective method of contraception. 2. Confirmed SARS-CoV-2 infection as determined by RAT in NP specimen collected w...