A Post-Exposure Prophylaxis Study of PF-07321332/Ritonavir in Adult Household Contacts of an Individual With Symptomatic COVID-19

• Status: Recruiting
• Trial end date: 2021-12-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of PF-07321332/ritonavir as postexposure prophylaxis for adult household contacts of a patient with COVID-19

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Ritonavir

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

• 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, other than localized skin cancer

• 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

• Has received or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments during the study period

• 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.