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.
It is a 2-part study in hospitalized COVID-19 patients.
- Part 1 is to evaluate safety, tolerability, PK and markers of clinical activity of
escalating doses of PF-07304814 given as 24-hour IV infusion.
2 planned and 3 optional cohorts with 8 participants each are planned.
- Part 2 is to evaluate safety, tolerability, PK and markers of clinical activity of
escalating doses of PF- 07304814 given as 120-hour infusion.
2 planned and 2 optional cohorts with 8 participants each are planned
Drug: PF-07304814
PF-07304814 is an anti-viral, formulated for intravenous delivery
Drug: Placebo
Placebo will be formulated for intravenous delivery
- Inclusion Criteria:
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.
- Exclusion Criteria:
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.
El Camino Health
Mountain View, California, United States
Palo Alto Medical Foundation
Mountain View, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
UC Davis Health Investigational Drug Pharmacy
Sacramento, California, United States
UC Davis Medical Center
Sacramento, California, United States
Massachusetts General Hospital Translational and Clinical Research Center
Boston, Massachusetts, United States
Massachusetts General Hospital, Clinical Trials Pharmacy
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Regional One Health
Memphis, Tennessee, United States
University Hospital Brugmann
Brussels, Belgium
Santa Casa De Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario Virgen Del Rocio
Sevilla, Spain
Pfizer CT.gov Call Center, Study Director
Pfizer