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

JRCT ID: jRCT2031210349

Registered date:28/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 02/10/2021
• Target sample size: 2880
• Countries of recruitment: United States,Japan,Brazil,Japan,South Africa,Japan,Puerto Rico,Japan,Spain,Japan,Hungary,Japan,Ukraine,Japan,Poland,Japan,Bulgaria,Japan,Turkey,Japan,Mexico,Japan,Argentina,Japan,Columbia,Japan,Taiwan,Japan,Republic of Korea,Japan,Malaysia,Japan,Czech Republic,Japan,Russian Federation,Japan,Thailand,Japan
• Study type: Interventional

Intervention(s)

Participants will receive study drug every 12 hours in one of the following regimen:
PF-07321332/ritonavir from Day 1 to Day 5, followed by placebo from Day 6 to Day 10
or
PF-07321332/ritonavir from Day 1 to Day 10
or
Placebo for 10 days from Day 1 to Day 10

Outcome(s)

• Primary Outcome: 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 ]

Secondary Outcome

*Percentage of participants who experience adverse events from Day 1 through Day 38.

Of the participants who have a negative RT-PCR result at baseline and who are at increased risk of severe COVID-19 illness:
*Proportion of participants with symptomatic, RT-PCR or Rapid Antigen Test confirmed SARS-CoV-2 infection from Day 1 through Day 14.
*Proportion of participants with COVID-19 related hospitalization or death from any cause by Day 28.

In participants by RT-PCR status at enrolment:
*Proportion of participants with symptomatic or asymptomatic RT-PCR or Rapid Antigen Test confirmed SARS-CoV-2 infection from Day 1 through Day 14.

Of the participants who have a negative RT-PCR result at baseline:
*Time to RT-PCR confirmed SARS-CoV-2 infection from Day 1 through Day 14
*Compare the duration of COVID-19 related signs and symptoms from Day 1 through Day 28.
*Compare the severity of COVID-19 related signs and symptoms from Day 1 through Day 28.
*Pharmacokinetics of PF-07321332 (Day 1 post dose and Day 5 pre dose).
*All cause mortality in participants from Day 1 through Day 38.
*Viral titers measured via RT-PCR in nasal swabs from Day 1 through Day 14.
*Number of days of hospital and ICU stay in participants with COVID-19 related hospitalization from Day 1 through Day 28.
*Number of COVID-19 related medical visits from Day 1 through Day 28.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

*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

Exclude criteria

*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

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): 2021-002894-24