First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending Dose And Extended Infusion of PF 07304814 In Hospitalized Participants With COVID-19.

It is a 2-part study in mild to moderate 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 infusions.

  3 planned and 2 optional cohorts with 8 participants each are planned.

• Part 2 is to evaluate safety, tolerability, PK and markers of clinical activity with extended 120-hour IV infusion of PF 07304814.

  1. planned and 1 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

• Experimental: PF-07304814

  Part 1:

  Cohort 1-5

  Part 2:

  Cohort 6,7

  Intervention: Drug: PF-07304814
• Placebo Comparator: Placebo

  Part 1:

  Cohort 1-5

  Part 2:

  Cohort 6,7

  Intervention: Drug: Placebo

• Inclusion Criteria:

  1. Male or female participants between the ages of 18 and 75 years.
  2. Confirmed SARS-CoV-2 infection as determined by standard RT- PCR assay.
  3. Hospitalized for COVID-19, with mild or moderate disease (8-point ordinal scale categories 4 to 7).
  4. Symptoms consistent with mild or moderate COVID-19 indicated by at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, shortness of breath (at rest or with exertion), or dyspnea.
  5. Total body weight >=50 kg (110 lb), BMI <35 kg/m2.

• 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 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 known HIV infection.
  5. Participants with a known medical history of ischemic heart disease, heart failure, dysrhythmia or other pre-existing cardiac condition.
  6. Participants with a known medical history of recurrent seizures.
  7. Confirmed concurrent active systemic infection other than COVID-19.
  8. Current diagnosis of cancer, unless in remission and untreated.
  9. Other medical or psychiatric condition including recent or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation
  10. Previous administration with any investigational drug (including Remdesivir, convalescent sera or Monoclonal antibody treatment for COVID-19 if not local standard of care) within 30 days.