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| Column | Value |
|---|---|
| Trial registration number | NCT05047601 |
|
Full text link
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
2021-09-17 |
|
Recruitment status
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
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
Last imported at : March 4, 2022, 9 p.m. Source : ClinicalTrials.gov |
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. |
|
Number of arms
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Pfizer |
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Inclusion age min
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Argentina;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;Japan;Malaysia;Mexico;Poland;Russia;South Africa;Spain;Thailand;Turkey;Ukraine;United States |
|
Type of patients
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
Close contacts to covid patients |
|
Severity scale
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Nov. 17, 2022, 4 a.m. Source : ClinicalTrials.gov |
2954 |
|
primary outcome
Last imported at : May 8, 2023, midnight Source : ClinicalTrials.gov |
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 |
|
Notes
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : May 8, 2023, midnight Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : Sept. 21, 2021, 5:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "every 12 hours from Day 1 through Day\u00a0", "treatment_id": 1663, "treatment_name": "Pf-07321332+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "very 12 hours from Day 1 through Day 10", "treatment_id": 1663, "treatment_name": "Pf-07321332+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |