COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04535167

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ClinicalTrials.gov_Inquiries@pfizer.com

2020-09-01

Completed

RCT

Randomized

Factorial

Blind label

multi-center

Treatment

inclusion criteria: male or female participants between the ages of 18 and 79 years. confirmed sars-cov-2 infection. hospitalized for covid-19. symptoms consistent with covid-19 indicated by at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath, new loss of taste and smell, nausea, chills, fatigue, rhinorrhea, diarrhea, vomiting or radiographic infiltrates by imaging consistent with covid-19 total body weight >=50 kg (110 lb), bmi <40 kg/m2; bmi <35 kg/m2 for 76- 79 years.

evidence of critical illness, defined by at least one of the following: respiratory failure, multi-organ dysfunction/failure, cardiac failure or septic shock participants that are anticipated by the study investigator to progress to critical disease, including mechanical ventilation, within 24 hours of enrolment participants with pre-existing moderate to severe cardiovascular disease, uncontrolled diabetes, or severe asthma or severe copd. 3.participants with a known medical history of recent acute or chronic liver disease (other than nash), chronic or active hepatitis b or c infection, or primary biliary cirrhosis. 4.participants with a known medical history of ischemic heart disease, heart failure, dysrhythmia or other pre-existing cardiac condition. 5. participants with known hiv infection, acute or chronic history of hepatitis b or c. 6.participants with a known medical history of recurrent seizures. 7. participants with history of venous thromboembolic event, including deep venous thrombosis or pulmonary embolism 8.confirmed concurrent active systemic infection other than covid-19. 9.current diagnosis of cancer, unless in remission and untreated. 10.other medical or psychiatric condition including recent or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation 11.females who are pregnant or breastfeeding.

2

Pfizer

18

75

Belgium;Brazil;Spain;United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

26

Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 1: SAD;Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 2: MAD;Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD;Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD;Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD;Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD;Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD;Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD;Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD;Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD;Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD;Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD;Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD;Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD;Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD;Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD;Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD;Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD;Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD;Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD

None

Phase 1

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