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

Ведущий спонсор: Pfizer

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

• COVID-19

Тип вмешательства: Drug

Название вмешательства: PF-07321332

Описание: PF-07321332

Тип вмешательства: Drug

Название вмешательства: Placebo for PF-07321332

Описание: Placebo

Тип вмешательства: Drug

Название вмешательства: Placebo for Ritonavir

Описание: Placebo

Тип вмешательства: Drug

Название вмешательства: Ritonavir

Описание: Ritonavir

Критерии:

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.

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

N/A

Здоровые волонтеры:

No

Фамилия: Pfizer CT.gov Call Center

Телефон: 1-800-718-1021

Argentina

Brazil

Bulgaria

Colombia

Czechia

Hungary

Japan

Korea, Republic of

Malaysia

Mexico

Poland

Puerto Rico

Russian Federation

South Africa

Spain

Taiwan

Thailand

Turkey

Ukraine

United States

2022-01-01

Тип: Sponsor

• Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)

• COVID-19

Метка: PF-07321332/ritonavir (5 days)

Тип: Experimental

Описание: 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

Метка: PF-07321332/ritonavir (10-Day)

Тип: Experimental

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

Метка: Placebo

Тип: Placebo Comparator

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

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Описание модели вмешательства: Eligible participants who are asymptomatic household contacts of an individual with symptomatic COVID-19 will be randomized (1:1:1) to receive orally every 12 hours: PF-07321332/ritonavir for 5 days followed by placebo for 5 days or PF-07321332/ritonavir for 10 days or Placebo for 10 days

Первичное назначение: Prevention

Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Описание маскировки: Double Blind Double Dummy