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Antiviral
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
Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), day 3, day 10 and day 14
Summary
This trial is testing a new medicine called PF-07817883 to see if it can lower the amount of COVID-19 virus in adults who have symptoms but are not hospitalized. The goal is to help these people recover faster by reducing the virus levels in their bodies.
Eligible Conditions
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1), day 3, day 10 and day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), day 3, day 10 and day 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in Logarithm Base 10 (Log10) Transformed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribo Nucleic Acid (RNA) Level on Day 5
Secondary study objectives
Change From Baseline in Log10 Transformed SARS-CoV-2 RNA Level on Days 3, 10 and 14
Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities
Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities
+3 moreSide effects data
From 2023 Phase 2 trial • 240 Patients • NCT057994953%
Alanine aminotransferase increased
3%
Supraventricular extrasystoles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
PF-07817883 300mg
PF-07817883 600mg
PF-07817883 100mg
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 3: high doseExperimental Treatment1 Intervention
Group II: Arm 2: medium doseExperimental Treatment1 Intervention
Group III: Arm 1: low doseExperimental Treatment1 Intervention
Group IV: Arm 4: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07817883
2022
Completed Phase 2
~370
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,669 Previous Clinical Trials
17,861,684 Total Patients Enrolled
73 Trials studying COVID-19
4,913,665 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,686 Total Patients Enrolled
56 Trials studying COVID-19
4,902,536 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another infection in your body that could affect how well the study treatment works.You have a type of cancer in your blood or immune system, or you are taking medication that weakens your immune system for another type of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 3: high dose
- Group 2: Arm 4: Placebo
- Group 3: Arm 1: low dose
- Group 4: Arm 2: medium dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.