Trial · NCT05047601
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
NCT05047601, Phase 2, Phase 3, Completed, Pfizer; results first posted 2023-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT05047601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05047601
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT05047601
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 2,954 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- COVID-19
- Interventions
- PF-07321332, Placebo for PF-07321332, Placebo for Ritonavir, Ritonavir
- First posted
- 2021-09-17
- Last updated
- 2023-05-06
- Other registries' IDs
- eudract:2021-002894-24
- Results first posted
- 2023-05-06
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | From Day 1 to Day 14 | Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | From start of study intervention (Day 1) up to end of safety follow-up (Day 38) | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure. |
| 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 | From Day 1 to Day 14 | Percentage of participants who had a symptomatic RT-PCR or RAT confirmed SARS-Cov-2 infection were reported in this outcome measure. The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. Index case was defined as participants with symptomatic COVID-19. |
| 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 | From Day 1 to Day 28 | The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. |
| 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 | From Day 1 to Day 14 | Percentage of participants who had asymptomatic RT-PCR or RAT confirmed SARS-CoV-2 infection through day 14 among participants with negative RT-PCR at baseline were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19. |
| Secondary | Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 14 | Number of days between first dose and confirmation of the SARS-CoV-2 infection by RT-PCR or RAT was reported in this outcome measure. |
| 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 | From Day 1 to Day 14 | Percentage of participants with a positive RT-PCR result at baseline who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19. |
| 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 | From Day 1 to Day 14 | Percentage of participants with a negative, positive, or missing RT-PCR result at baseline, who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19. |
| 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 | From Day 1 to Day 28 | Participants were categorized according to severity of signs and symptoms as no, mild, moderate, severe in this outcome measure. The 12 signs and symptoms included stuffy or runny nose, sore throat, shortness of breath or difficulty breathing, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea. Participants recorded their daily severity rating of their symptoms over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. |
| 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 | From Day 1 to Day 28 | This outcome measure has been reported in terms of number of participants according to days of symptomatic SARS-CoV-2 infection through Day 28. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | From Day 1 to Day 14 | Modified Intent-To-Treat (mITT) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | From start of study intervention (Day 1) up to end of safety follow-up (Day 38) | Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | From Day 1 to Day 14 | Modified Intent-To-Treat (mITT2) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline and were at increased risk of severe COVID-19 illness. | Percentage of participants | NUMBER |
| 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 | From Day 1 to Day 28 | mITT2 population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline and were at increased risk of severe COVID-19 illness. | Percentage of participants | NUMBER |
| 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 | From Day 1 to Day 14 | mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 14 | mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. | Days | MEDIAN |
| 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 | From Day 1 to Day 14 | mITT1 population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a positive RT-PCR result at baseline. | Percentage of participants | NUMBER |
| 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 | From Day 1 to Day 14 | Modified Intent-To-Treat (mITT3) population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative, positive or missing RT-PCR result at baseline. | Percentage of Participants | NUMBER |
| 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 | From Day 1 to Day 28 | mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. | Percentage of participants | NUMBER |
| 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 | From Day 1 to Day 28 | mITT population included all participants randomly assigned to study intervention who received at least 1 dose of study intervention and had a negative RT-PCR result at baseline. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group205
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 2.607 | Percentage of participants | ||
| 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 | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 2.410 | Percentage of participants | ||
| 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 | Placebo | 3.929 | Percentage of participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | TEAEs | 218 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | TEAEs | 212 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Placebo | TEAEs | 195 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | SAEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | SAEs | 1 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Placebo | SAEs | 2 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | AEs led to discontinuation of study | 0 | Participants |
1 to 10 of 205Source ClinicalTrials.gov
See all 205 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 921 | |
| Overall Study | STARTED | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 917 | |
| Overall Study | STARTED | Placebo | 898 | |
| Overall Study | Treated | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 913 | |
| Overall Study | Treated | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 911 | |
| Overall Study | Treated | Placebo | 897 | |
| Overall Study | COMPLETED | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 877 | |
| Overall Study | COMPLETED | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 864 | |
| Overall Study | COMPLETED | Placebo | 863 | |
| Overall Study | NOT COMPLETED | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 44 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 23 | 912 | |
| other | Diarrhoea | Gastrointestinal disorders | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 22 | 911 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 15 | 898 | |
| other | Nausea | Gastrointestinal disorders | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 16 | 912 | |
| other | Nausea | Gastrointestinal disorders | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 12 | 911 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 14 | 898 | |
| other | Asthenia | General disorders | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 10 | 912 | |
| other | Asthenia | General disorders | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 7 | 911 | |
| other | Asthenia | General disorders | Placebo | 17 | 898 | |
| other | COVID-19 | Infections and infestations | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 27 | 912 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 0 | 912 |
| Total, all-cause mortality | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 0 | 911 |
| Total, all-cause mortality | Placebo | 0 | 898 |
| Total, other adverse events | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 176 | 912 |
| Total, other adverse events | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 173 | 911 |
| Total, other adverse events | Placebo | 152 | 898 |
| Total, serious adverse events | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 5 Days | 3 | 912 |
| Total, serious adverse events | Nirmatrelvir (PF-07321332) 300 mg + Ritonavir 100 mg 10 Days | 1 | 911 |
| Total, serious adverse events | Placebo | 2 | 898 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39018532 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05047601
GET https://conductscience.org/api/trials/v1/NCT05047601/results?page=2