Phase 3
N=2,736
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
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT05047601 ↗Enrolled (actual)
2,736
Serious AEs
0.2%
Results posted
May 2023
Primary outcome: Primary: Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline — 2.607; 2.410; 3.929 Percentage of participants — p=0.1722
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PF-07321332 (Drug); Placebo for PF-07321332 (Drug); Placebo for Ritonavir (Drug); Ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline |
2.607; 2.410; 3.929 | 0.1722 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation |
218; 212; 195; 3; 1; 2 | — |
| SECONDARY Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness |
2.871; 2.645; 3.465 | 0.6766 |
| SECONDARY Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness |
0; 0; 0.165 | — |
| SECONDARY Percentage of Participants With Asymptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline |
2.014; 1.928; 3.095 | 0.1869 |
| SECONDARY Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline |
NA; NA; NA | 0.0368 sig |
| SECONDARY Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Positive RT-PCR at Baseline |
28.947; 45.833; 37.931 | 0.4126 |
| SECONDARY Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative, Positive or Missing RT-PCR at Baseline |
3.712; 4.848; 5.269 | 0.1333 |
| SECONDARY Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline |
81.517; 83.373; 81.667; 7.820; 8.193; 7.619 | — |
| SECONDARY Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline |
1; 7; 2; 2; 0; 1 | — |
| SECONDARY Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332) |
1489; 1472; 1688; 1657 | — |
| SECONDARY Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline |
0; 0; 0 | — |
| SECONDARY Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline |
0.042; 0.035; 0.038; 0.078; 0.053; 0.108 | — |
| SECONDARY Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline |
4.870; 4.470; 4.837; 3.286; 2.724; 3.104 | — |
| SECONDARY Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline |
844; 830; 840; 0; 0; 0 | — |
| SECONDARY Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline |
0.0067; 0.0057; 0.0066 | 0.7991 |
Summary
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
Eligibility Criteria
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 in the past 6 months
- 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 requiring treatment with prohibited medication.
- 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 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.
Data sourced from ClinicalTrials.gov (NCT05047601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.