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

Pfizer

Status and phase: Completed; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: Ritonavir; Drug: PF-07321332; Drug: Placebo for Ritonavir; Drug: Placebo for PF-07321332

Study type: Interventional

Funder types: Industry

Identifiers

NCT05047601

C4671006

2021-002894-24 (EudraCT Number)

EPIC-PEP (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 2,954 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,954 participants in 3 patient groups, including a placebo group

PF-07321332/ritonavir (5 days)

Experimental group

Description:

Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10

Treatment:

Drug: Ritonavir

Drug: Placebo for Ritonavir

Drug: PF-07321332

Drug: Placebo for PF-07321332

PF-07321332/ritonavir (10-Day)

Experimental group

Description:

Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10.

Treatment:

Drug: Ritonavir

Drug: PF-07321332

Placebo

Placebo Comparator group

Description:

Participants will receive placebo every 12 hours from Day 1 through Day 10.

Treatment:

Drug: Placebo for Ritonavir

Drug: Placebo for PF-07321332