| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 23.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10084460 |
| E.1.2 | Term | COVID-19 treatment |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| •To compare the efficacy of 5-day and 10-day regimens of PF-07321332/ritonavir versus placebo in preventing symptomatic RT-PCR confirmed SARS-CoV-2 infection in adult participants who have a negative RT-PCR result at baseline and who are household contacts of an individual with symptomatic COVID-19. |
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| E.2.2 | Secondary objectives of the trial |
•To describe the safety and tolerability of 5-day and 10-day regimens of PF-07321332/ritonavir relative to placebo in adult participants who have a negative or positive RT-PCR result at baseline and who are household contacts of an individual with symptomatic COVID-19.
•To compare the efficacy of 5-day and 10-day regimens of PF 07321332/ritonavir versus placebo in preventing symptomatic RT PCR confirmed SARS CoV-2 infection in adult participants who have a negative RT-PCR result at baseline, who are at increased risk of severe COVID-19 illness, and who are household contacts of an individual with symptomatic COVID-19.
•To compare the efficacy of 5-day and 10-day regimens of PF 07321332/ritonavir versus placebo in preventing SARS CoV-2 infection in adult participants who have a negative or positive RT-PCR result at baseline and who are household contacts of an individual with symptomatic COVID-19.
*details of remaining objectives in Protocol |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1.Participants ≥18 years of age (or the minimum country specific age of consent if >18) at the screening visit.
•WOCBP may be enrolled.
•All fertile participants must agree to use a highly effective method of contraception.
2.Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3.Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts (ie, living in the same residence, see Appendix 13) of an individual who is symptomatic and recently tested positive for SARS-CoV-2 (ie, index case: patient with symptomatic COVID-19). To be included in the study, participants must be randomized within 24 hours of their negative SARS-CoV-2 rapid antigen test and within 96 hours of collection of the index case’s first positive SARS-CoV-2 test.
Note: The index case will have confirmation of SARS-CoV-2 infection by RT-PCR or other molecular or antigen tests that detect viral RNA or protein (see Section 8.1.5).
Note: Participants with a negative screening SARS-CoV-2 local rapid antigen test result and whose baseline RT-PCR result is returned as positive would be allowed to remain on treatment in the study.
Note: Asymptomatic is defined as having no signs/symptoms consistent with COVID-19 and symptomatic is defined as having at least 1 of the specified signs or symptoms consistent with COVID-19 (see Appendix 9).
4.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.
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| E.4 | Principal exclusion criteria |
1.History of SARS-CoV-2 infection as determined by a molecular test (antibody, antigen, or nucleic acid) from any specimen collected at any time before or during the screening visit.
2.Experiencing measured fever (documented temperature >38˚C or 100.4˚F) or other signs or symptoms consistent with COVID-19.
3.Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, or primary biliary cirrhosis, ChildPugh Class B or C, or acute liver failure.
4.CKD or have known moderate to severe renal impairment.
5.Known HIV infection with viral load >400 copies/mL within the last 6 months or taking prohibited medications for HIV treatment (from known medical history within past 6 months of the screening visit)
6.Suspected or confirmed concurrent active systemic infection that may interfere with the evaluation of response to the study intervention.
7.Active cancer, other than localized skin cancer, requiring treatment (including palliative treatment) that must be administered/continued during the trial period.
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.Has 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.
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.
13.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.
14.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 (includes partial or full vaccinations for multiple-dose vaccines).
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 End of Study visit.
16.Previous administration with an investigational drug within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
17.Known or prior participation in this trial or another trial involving PF-07321332.
18.Participants with known history of any of the following abnormalities in clinical laboratory tests (within 6 months of the screening visit):
•AST or ALT level ≥2.5 X ULN;
•Total bilirubin level ≥2 X ULN (≥ 3X ULN for Gilbert’s syndrome);
•eGFR <45 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula46
•Absolute neutrophil count <1,000/mm3.
Note: If the investigator suspects the participant may have any of the above laboratory values, confirmatory tests should be performed at screening to confirm eligibility before the first dose of study intervention.
19.Females who are pregnant or breastfeeding.
20.Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Of the participants who have a negative RT-PCR result at baseline:
•Proportion of participants who develop a symptomatic, RT-PCR confirmed SARS-CoV-2 infection through Day 14. |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
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| E.5.2 | Secondary end point(s) |
•Incidence of TEAEs
•Incidence of SAEs and AEs leading to discontinuation.
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 confirmed SARS-CoV-2 infection through Day 14.
•Proportion of participants with COVID-19 related hospitalization or death from any cause by Day 28.
Of the participants who have a negative RT-PCR result at baseline:
•Proportion of participants with asymptomatic RT-PCR confirmed SARS-CoV-2 infection through Day 14.
•Time to RT-PCR confirmed SARS-CoV-2 infection through Day 14.
Of the participants who have a positive RT-PCR result at baseline:
•Proportion of participants with symptomatic RT-PCR confirmed SARS-CoV-2 infection through Day 14.
Of the participants who have a negative or positive RT-PCR result at baseline:
•Proportion of participants with symptomatic RT-PCR confirmed SARS-CoV-2 infection through Day 14.
Of the participants who have a negative RT-PCR result at baseline:
•Proportion of participants with no, mild, moderate, or severe signs and symptoms attributed to COVID-19 through Day 28.
•Number of days of symptomatic SARS-CoV-2 infection through Day 28.
•PF-07321332 PK in plasma and whole blood (if feasible).
Of the participants who have a negative RT-PCR result at baseline:
•Proportion of participants with death (all-cause) through Day 38.
Of the participants who have a negative RT-PCR result at baseline:
•Viral titers measured via RT-PCR in nasal swabs over time.
Of the participants who have a negative RT-PCR result at baseline:
•Number of days of hospital and ICU stay in participants with COVID 19 related hospitalization through Day 28.
•Number of COVID-19 related medical visits through Day 28.
Of the participants who have a negative RT-PCR result at baseline:
•Number of COVID-19 related medical visits through Day 28.
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
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| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 46 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Brazil |
| China |
| Colombia |
| India |
| Japan |
| Korea, Republic of |
| Malaysia |
| Mexico |
| Peru |
| Puerto Rico |
| Russian Federation |
| South Africa |
| Taiwan |
| Thailand |
| Turkey |
| Ukraine |
| United States |
| Bulgaria |
| Hungary |
| Poland |
| Spain |
| Czechia |
| Argentina |
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| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 2 |
| E.8.9.1 | In the Member State concerned days | 8 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 2 |
| E.8.9.2 | In all countries concerned by the trial days | 8 |
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