First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.
NCT04535167
ABOUT THIS STUDY
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1. Male or female participants between the ages of 18 and 79 years.
2. Confirmed SARS-CoV-2 infection.
3. Hospitalized for COVID-19.
4. 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
5. Total body weight >=50 kg (110 lb), BMI <40 kg/m2; BMI <35 kg/m2 for 76- 79 years.
-
1. Evidence of critical illness, defined by at least one of the following:
Respiratory failure, Multi-organ dysfunction/failure, Cardiac failure or septic
shock
2. Participants that are anticipated by the study Investigator to progress to
critical disease, including mechanical ventilation, within 24 hours of enrolment
3. 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.
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Descriptive Information | |||||
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Brief Title ICMJE | First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19. | ||||
Official Title ICMJE | A PHASE 1B, 2-PART, DOUBLE-BLIND, PLACEBO-CONTROLLED, SPONSOR-OPEN STUDY, TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE ASCENDING (24-HOUR, PART 1) AND EXTENDED (120-HOUR, PART 2) INTRAVENOUS INFUSIONS OF PF-07304814 IN HOSPITALIZED PARTICIPANTS WITH COVID-19 | ||||
Brief Summary | It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients hospitalized with SARS-CoV-2 virus infection. | ||||
Detailed Description | It is a 2-part study in hospitalized COVID-19 patients.
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Intervention Model Description: Part 1 will have 2 planned cohorts. Each escalating cohort will be initiated for enrollment after assessment of safety, tolerability and PK data from previous cohorts by an independent IRC and is deemed acceptable. Part 2 will have 2 planned cohort and each escalating cohort will be initiated after all safety, tolerability and PK data from previous cohort is evaluated and is deemed acceptable by a competent regulatory authority. Primary Purpose: Treatment | ||||
Condition ICMJE | Viral Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 72 | ||||
Original Estimated Enrollment ICMJE | 56 | ||||
Estimated Study Completion Date ICMJE | July 5, 2021 | ||||
Estimated Primary Completion Date | July 5, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 79 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04535167 | ||||
Other Study ID Numbers ICMJE | C4611001 2020-003905-73 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |