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.
Condition: Viral Disease
MeSH terms: COVID-19; Virus Diseases
Intervention: PF-07304814; Placebo
Intervention description: PF-07304814 is an anti-viral, formulated for intravenous delivery; Placebo will be formulated for intravenous delivery
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial 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.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: COVID-19; SARS-COV-2

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.
    

Eligibility criteria:

        -  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.