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A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection

NCT05047601

CompletedPhase 2, Phase 3

Sponsor: Pfizer

Conditions: COVID-19

Interventions: PF-07321332, Placebo for PF-07321332, Placebo for Ritonavir, Ritonavir

Countries: United States, Argentina, Brazil, Bulgaria, Colombia, Czechia, Hungary, Japan

The purpose of this clinical trial is to learn whether the study medicine prevent symptoms of COVID-19 in adults who have been exposed to household member(s) with a confirmed symptomatic COVID-19 infection. All participants in the study will receive treatment for COVID-19 as needed, based on their regular doctor's recommendation. Two-thirds of participants will also receive two study medicines (PF-07321332 and ritonavir) by mouth twice a day for either five or ten days. We will compare the experiences of people receiving the study medicines to those of the people who do not. This will help us determine if the study medicines are safe and effective

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts with exposure within 96 hours to an individual who is symptomatic and recently tested positive for SARS CoV-2.
* Fertile participants must agree to use a highly effective method of contraception

Exclusion Criteria:

* History of SARS-CoV-2 infection in the past 6 months
* Experiencing measured fever (documented temperature \>38˚C or 100.4˚F) or other signs or symptoms consistent with COVID-19
* Known medical history of active liver disease
* Chronic Kidney Disease or have known moderate to severe renal impairment.
* Known Human Immunodeficiency Virus (HIV) infection with viral load \> 400 copies/ml within the last 6 months or taking prohibited medications for HIV treatment
* Suspected or confirmed concurrent active systemic infection
* Active cancer requiring treatment with prohibited medication.
* Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
* Has received approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products within 6 months of screening
* Has received any SARS-CoV-2 vaccine within 6 months prior to screening or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments through Day 38.
* Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
* Known or prior participation in this trial or another trial involving PF-07321332.
* Females who are pregnant or breastfeeding.

Locations (170)

Pelham, Alabama, United States
Tucson, Arizona, United States
Fullerton, California, United States
San Francisco, California, United States
Bradenton, Florida, United States
Brandon, Florida, United States
Brandon, Florida, United States
Coral Gables, Florida, United States
Cutler Bay, Florida, United States
Cutler Bay, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah Gardens, Florida, United States
Lutz, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
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