Coronavirus Disease 2019 (COVID-19) MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants =18 to =59 years of age (or the minimum country specific age of consent if >18) at the time of the Screening Visit. •WOCBP may be enrolled. •All fertile participants must agree to use a highly effective method of contraception. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. 2. Confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen collected within 5 days prior to randomization. Note: RT-PCR is the preferred method; however, with evolving approaches to confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed. The test result must be available to confirm eligibility. Participants may be enrolled based on positive results of a rapid SARS-CoV-2 antigen test performed at screening. 3. Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified signs/symptoms attributable to COVID-19 present on the day of randomization (see Appendix 9 for criteria). 4. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. 5. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Please refer to section 5.1 of the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 226
Exclusion criteria
Exclusion criteria: 1. Has at least 1 characteristic or underlying medical condition (self-report is acceptable) associated with an increased risk of developing severe illness from COVID-19 including: Note: Participants with these conditions who have received at least 1 dose of a SARS CoV-2 vaccine are considered to be at lower risk of developing severe disease and are therefore considered eligible. •BMI >25; •Current smoker (cigarette smoking within the past 30 days) and history of at least 100 lifetime cigarettes; •Chronic lung disease (if asthma, requires daily prescribed therapy); •Known diagnosis of hypertension; •CVD, defined as history of any of the following: myocardial infarction, stroke, TIA, HF, angina with prescribed nitroglycerin, CABG, PCI, carotid endarterectomy, and aortic bypass; •Type 1 or Type 2 diabetes mellitus; •CKD; • Sickle cell disease; • Neurodevelopmental disorders (eg, cerebral palsy, Down’s syndrome) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes and severe congenital anomalies); •Active cancer other than localized skin cancer, including those requiring treatment (including palliative treatment), as long as the treatment is not among the prohibited medications that must be administered/continued during the trial period; •Medical-related technological dependence (eg, CPAP [not related to COVID-19]). 2.Immunosuppressive disease (eg, bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening medications: •Has received corticosteroids equivalent to prednisone =20 mg daily for at least 14 consecutive days within 30 days prior to study entry; •Has received treatment with biologics (eg, infliximab, ustekinumab, etc.), immunomodulators (eg, methotrexate, 6MP, azathioprine, etc), or cancer chemotherapy within 90 days prior to study entry’; •HIV infection with CD4+ cell count 400 copies/ml or taking prohibited medications for HIV treatment (Appendix 8). 9. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention. 10. Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator. 11. History of hypersensitivity or other contraindication to any of the components of the study intervention, as determined by the investigator. 12. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of PF-07321332/ritonavir to placebo for the treatment of symptomatic COVID-19 in nonhospitalized adult participants with COVID-19 who are at low risk of progression to severe disease.;Secondary Objective: - To describe the safety and tolerability of PF-07321332/ritonavir relative to placebo in the treatment of nonhospitalized symptomatic adult participants with COVID-19 who are at low risk of progression to severe disease. - To compare PF-07321332/ritonavir to placebo for the duration and severity of signs and symptoms in nonhospitalized symptomatic adult participants with COVID-19 who are at low risk of progression to severe disease. - To compare PF-07321332/ritonavir versus placebo for COVID-19 related medical visits in nonhospitalized adult participants with COVID-19 who are at low risk of progression to severe disease. - To compare PF-07321332/ritonavir versus placebo for hospitalization and all-cause mortality in nonhospitalized adult participants with COVID-19 who are at low risk of progression to severe disease. *details of remaining objectives in Protocol;Primary end point(s): Time (days) to sustained alleviation of all targeted COVID-19 signs/symptoms through Day 28.;Timepoint(s) of evaluation of this end point: - through day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Incidence of TEAEs. •Incidence of SAEs and AEs leading to discontinuations •Proportion of participants with severe signs/symptoms attributed to COVID-19 through Day 28. •Time (days) to sustained resolution of all targeted COVID-19 signs/symptom through Day 28. •Duration of each targeted COVID 19 sign/symptom. •Progression to a worsening status in 1 or more self reported COVID 19 associated symptoms through Day 28. •Proportion of participants with a resting peripheral oxygen saturation =95% at Days 1 and 5. •Number of COVID-19 related medical visits through Day 28. •Number of days in hospital and ICU stay in participants with COVID-19 related hospitalization through Day 28. •Proportion of participants with COVID-19 related hospitalization or death from any cause through Day 28. •Proportion of participants with death (all cause) through Week 24. •PF-07321332 PK in plasma and whole blood (if feasible). •Viral titers measured via RT-PCR in nasal swabs over time.;Timepoint(s) of evaluation of this end point: •throughout study •throughout study •through Day 28. • through Day 28. •through Day 28. •throughout study • through Day 28. •at Days 1 and 5. • through Day 28. • through Day 28. • through Day 28. •through Week 24. • throughout study • throughout study | — |
Countries
Argentina, Brazil, Bulgaria, China, Colombia, Czechia, Czech Republic, Hungary, India, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Peru, Poland, Puerto Rico, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed