Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UC Davis
Dates
study started
estimated completion

Description

Summary

It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients with SARS-CoV-2 virus infection and with mild-to-moderate symptoms.

Official Title

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 MILD TO MODERATE COVID-19

Details

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.
  • planned and 1 optional cohorts with 8 participants each are planned

Keywords

Viral Disease COVID-19 SARS-COV-2 Virus Diseases

Eligibility

You can join if…

Open to people ages 18-75

  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.

You CAN'T join if...

  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.

Locations

  • UC Davis Health Investigational Drug Pharmacy not yet accepting patients
    Sacramento California 95817 United States
  • UC Davis Medical Center not yet accepting patients
    Sacramento California 95817 United States
  • Hoag Memorial Hospital Presbyterian not yet accepting patients
    Newport Beach California 92663 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT04535167
Phase
Phase 1
Study Type
Interventional
Last Updated