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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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

Key facts

Study ID

NCT05047601

Run by

Pfizer

People needed

2954

Starts

2021-09-09

Expected to finish

2022-04-12

Last updated by the study team

2023-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Institute for Liver Health dba Arizona Clinical Trials — Tucson, Arizona, United States
• Ascada Health PC — Fullerton, California, United States
• Optimus Medical Group — San Francisco, California, United States
• Synergy Healthcare — Bradenton, Florida, United States
• MOORE Clinical Research, Inc. — Brandon, Florida, United States
• TrueBlue Clinical Research — Brandon, Florida, United States
• Herco Medical and Research Center Inc — Coral Gables, Florida, United States
• Advance Clinical Research Group — Cutler Bay, Florida, United States
• Beautiful Minds Clinical Research Center — Cutler Bay, Florida, United States
• Qway Research — Hialeah, Florida, United States
• Eastern Research Inc — Hialeah, Florida, United States
• Inpatient Research Clinic — Hialeah, Florida, United States
• Doral Medical Research,LLC — Hialeah, Florida, United States
• Unlimited Medical Research Group, LLC — Hialeah Gardens, Florida, United States
• ASCLEPES Research Centers — Lutz, Florida, United States
• Angels Clinical Research Institute — Miami, Florida, United States
• LCC Medical Research Institute, LLC — Miami, Florida, United States
• Premium Medical Research Corp — Miami, Florida, United States
• Global Health Clinical Trials Corp — Miami, Florida, United States
• South Florida Research Center, Inc. — Miami, Florida, United States
• University of Miami Health System — Miami, Florida, United States
• I.V.A.M. Clinical & Investigational Center, LLC — Miami, Florida, United States
• Medical Research of Westchester Inc — Miami, Florida, United States
• C'A Research — Miami, Florida, United States
• Cahaba Research Inc — Pelham, Alabama, United States

Full record on ClinicalTrials.gov

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