CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 240 enrolled
Drug / intervention
PF-07817883 +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/NCT05799495
NCT05799495Phase 2Completed

A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO EVALUATE VIROLOGICAL RESPONSE AND SAFETY OF ORAL PF-07817883 IN NON-HOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19

Pfizer·interventional·Posted Apr 5, 2023·Updated Oct 9, 2024

In Brief

A Phase 2 clinical trial evaluating PF-07817883 and Placebo for SARS-CoV-2 Infection. Completed, enrolled 240 participants across 53 sites.

Detailed Summary

The purpose of the study is to understand the effects and safety of PF-07817883 treatment. The study wants to know how PF-07817883 treatment lowers the level of the virus that causes COVID 19. To understand that samples are collected from adult participants who have the symptoms of COVID 19 but are not hospitalized. The study is seeking for participants who: * are 18 years of age or older at the time of entering the study. * have a positive rapid antigen test within 48 hours before entering the study. Rapid antigen test is a test done to confirm the presence of a specific virus in the body. * have onset of signs or symptoms of COVID-19 within 5 days before entering the study. * have at least 1 of the specified signs or symptoms of COVID-19 present on the day of entering the study. Around 228 participants with a confirmed case of COVID 19 are planned to be taken into the study. Participants will be randomly grouped to receive PF-07817883. Three groups will receive 100, 300, 600mg of PF-07817883 and one of the groups will receive placebo (a pill that doesn't have any medicines) orally every 12 hours for 5 days. The study is going to last up to 5 weeks. This includes the initial period of selecting participants, participants receiving the medicine or the placebo and then a 4-week follow-up period after giving the participants the last medicine. The study team will monitor how each participant is doing with the study treatment during the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202420252026
First PostedApr 5, 2023
Enrollment StartMay 23, 2023
Primary CompletionSep 13, 2023
Study CompletionOct 11, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.2 years ago

Interventions

PF-07817883drug

Arm 1: low dose Arm 2: medium dose Arm 3: high dose

Placebodrug

Placebo