First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics of PF-07304814 In Hospitalized Participants With COV

An experimental treatment called Remdesivir was provided on a compassionate-use basis to patients hospitalized with COVID-19, an illness caused by infection with SARS-CoV-2.

Study Type/Phase: 1b
Status: Completed; Not Recruiting

The purpose of this study is to evaluate the safety, effectiveness, and dosing of an investigational drug called PF-07304814 for SARS-CoV-2 infection. This is a Phase 1 trial that will occur in two parts. A Phase 1 trial is the first step in involving human subjects to test an investigational drug. During Part 1 of this study, subjects will be administered the drug intravenously over a period of 24 hours to determine an appropriate dosing of the drug. This will be followed by Part 2, an extended infusion, where the drug will be administered intravenously over 5 days based on the determined dosage in Part 1.

There remains an urgent need for additional safe and effective therapeutic interventions for COVID-19 that shortens time to clinical recovery and prevents the progression of infection to more serious disease and death. The function of PF-07304814 is to inhibit the activity of an enzyme (SARS 3CL protease) that is essential in the life cycle of SARS-CoV-2, thus preventing viral replication. This drug has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19. Subjects will be followed for at least 28 days post treatment. Participants may be asked to provide biological samples including blood, urine, nasal, and saliva swabs for study analysis which may provide a greater understanding of the study intervention.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Between the ages of 18 and 75 years of age weighing at least 50 kg and BMI <35 kg/m2
  • Willing to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations, and other study procedures
  • SARS-CoV-2 infection confirmed by PCR test ≤3 days before screening
  • Currently hospitalized for COVID-19, with mild or moderate disease
  • Symptoms consistent with mild or moderate COVID-19
  • Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  • Evidence of critical illness
  • With pre-existing moderate to severe cardiovascular disease, uncontrolled diabetes, or severe asthma or severe chronic obstructive pulmonary disease
  • Known medical history of recent acute or chronic liver disease, including chronic or active hepatitis B or C infection, or primary biliary cirrhosis
  • Known HIV infection and/or who are receiving a boosted anti-retroviral treatment regimen
  • Known medical history of ischemic heart disease, heart failure, dysrhythmia or other pre-existing cardiac condition that may confuse interpretation of ECG or cardiovascular findings
  • Known medical history of recurrent seizures
  • Confirmed concurrent active systemic infection other than COVID-19
  • Current diagnosis of cancer, unless in remission and untreated
  • Concurrent treatment with other agents that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4
  • Received systemic oral, intravenous, or intramuscular corticosteroid therapy within the previous 28 days, except as required for COVID-19 treatment
  • AST or ALT level≥3 x ULN
  • Bilirubin level≥1.5 x ULN
  • CLcr< mL/min using Crockcroft-Gault equation
  • Absolute neutrophil count <1000/mm3
  • Positive pregnancy test
  • Breastfeeding woman

Principal Investigator

Ganesh Krishna, MD

Sponsor

Pfizer Inc.

Contact

Karen Ng, Clinical Research Coordinator
Taft Center for Clinical Research
650-962-4463
karen_ng@elcaminohealth.org

 

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

 

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