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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05011513 |
|
Full text link
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : July 12, 2022, 1:30 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
2021-08-18 |
|
Recruitment status
Last imported at : Oct. 7, 2022, 8 a.m. Source : ClinicalTrials.gov |
Terminated |
|
Study design
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - confirmed sars-cov-2 infection 5 days prior to randomization - initial onset of covid-19 signs/symptoms within 5 days of randomization - fertile participants must agree to use a highly effective method of contraception |
|
Exclusion criteria
Last imported at : April 14, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
has at least one underlying medical condition associated with an increased risk of developing severe illness from covid-19 history of or need for hospitalization for the medical treatment of covid-19 prior diagnosis of sars-cov-2 infection (reinfection) known medical history of liver disease receiving dialysis or have known renal impairment known human immunodeficiency virus (hiv) infection with viral load > 400 copies/ml or taking prohibited medications for hiv treatment suspected or confirmed concurrent active systemic infection other than covid-19 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 or is expected to receive monoclonal antibody treatment or convalescent covid-19 plasma has received any sars-cov-2 vaccine within 12 months of screening participating in another interventional clinical study with an investigational compound or device, including those for covid-19 known prior participation in this trial or other trial involving pf-07321332 oxygen saturation of < 92% on room air females who are pregnant or breastfeeding |
|
Number of arms
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Pfizer |
|
Inclusion age min
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 7, 2022, 8 a.m. Source : ClinicalTrials.gov |
Argentina;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;Japan;Republic of Korea;Malaysia;Mexico;Poland;Puerto Rico;Romania;Slovakia;South Africa;Spain;Thailand;Turkey;Ukraine;United States |
|
Type of patients
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : Aug. 17, 2023, 10:09 a.m. Source : ClinicalTrials.gov |
1440 |
|
primary outcome
Last imported at : Aug. 17, 2023, 10:09 a.m. Source : ClinicalTrials.gov |
Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28 |
|
Notes
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Aug. 17, 2023, 10:09 a.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
|
Arms
Last imported at : Aug. 23, 2021, 7 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "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"}] |