COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2031210349

Clinical Trials Information Desk

clinical-trials@pfizer.com

2021-09-28

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

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

*History of SARS-CoV-2 infection in the past 6 months*Experiencing measured fever (>38 degrees) 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 a viral load greater than 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 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

3

Kawai Norisuke

18

100

Argentina;Brazil;Bulgaria;Czech Republic;Democratic People's Republic of Korea;Hungary;Japan;Malaysia;Mexico;Poland;Puerto Rico;Russia;South Africa;Spain;Taiwan;Thailand;Turkey;Ukraine;United States

Close contacts to covid patients

N/A

2880

Proportion of participants who have a negative reverse transcription polymerase chain reaction (RT-PCR) result at baseline who develop a symptomatic; RT-PCR or rapid antigen test confirmed SARS-CoV-2 infection. [ Time Frame: Day 1 through Day 14 ]

Phase 3

[{"arm_notes": "PF-07321332/ritonavir from Day 1 to Day 5, followed by placebo from Day 6 to Day 10", "treatment_id": 1663, "treatment_name": "Pf-07321332+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "PF-07321332/ritonavir from Day 1 to Day 10", "treatment_id": 1663, "treatment_name": "Pf-07321332+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]