A Phase 2/3 Efficacy And Safety Study Of PF-07321332/Ritonavir in Nonhospitalized High Risk Adult Participants With COVID 19
- Conditions
- Coronavirus Disease 2019 (COVID-19)MedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-002895-38-BG
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 3000
1. Participants =18 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.Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19 including:
- =60 years of age;
- BMI >25;
- Current smoker (cigarette smoking within the past 30 days) and history of at least 100 lifetime cigarettes;
- Immunosuppressive disease (eg, bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening medications:
o Has received corticosteroids equivalent to prednisone =20 mg daily for at least 14 consecutive days within 30 days prior to study entry.
o Has received treatment with biologics (eg, infliximab, ustekinumab), immunomodulators (eg, methotrexate, 6MP, azathioprine) or cancer chemotherapy within 90 days prior to study entry.
o HIV infection with CD4 cell count <200 mm3 and a viral load less than 400 copies/mL
- 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 provided the participant does not meet Exclusion Criterion 5;
- 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 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]).
5. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
6. 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.
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 2700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
1. History of hospitalization for the medical treatment of COVID-19.
2. Current need for hospitalization or anticipated need for hospitalization within 48 hours after randomization in the clinical opinion of the site investigator (see Section 8.1.2.)
3. Prior to current disease episode, any confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any specimen collection.
4. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh Class B or C, or acute liver failure.
5. Receiving dialysis or have known moderate to severe renal impairment [ie, eGFR <45 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula]
6. Known HIV infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment from known medical history within past 6 months of the screening visit) (Appendix 8).
7. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
8. 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.
9. History of hypersensitivity or other contraindication to any of the components of the study intervention, as determined by the investigator.
10. 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 inappropriate for the study.
11. Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance and for which elevated plasma concentrations may be associated with serious and/or life-threatening events during treatment and for 4 days after the last dose of PF-07321332/ritonavir (See Appendix 8).
12. Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days prior to first dose of PF-07321332/ritonavir and during study treatment (see Appendix 8).
13. Has received or is expected to receive convalescent COVID-19 plasma.
14. Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit.
15. Is unwilling to abstain from participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 therapeutics, through the long-term follow-up visit.
16. Previous administration with any investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
17. Known prior participation in this trial or other trial involving PF-07321332.
18. Known history of any of the following abnormalities in clinical laboratory tests (within past 6 months of the screening visit):
- AST or ALT level =2.5 X ULN;
- Total bilirubin =2 X ULN (=3 X ULN for Gilbert’s syndrome);
- Absolute neutrophil count <1000/mm3.
- GFR <45 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula30
Note: If the investigator suspects the pa
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method