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.

NCT04535167

Last updated date
Study Location
Henry Ford Health System
Detroit, Michigan, 48202, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Viral Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-79 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Viral DiseaseFirst-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.
NCT04535167
  1. Detroit, Michigan
  2. Cheektowaga, New York
  3. Williamsville, New York
  4. Brussels,
  5. Brussels,
  6. Majadahonda, Madrid
  7. Barcelona,
  8. Madrid,
  9. Sevilla,
  10. Mountain View, California
  11. Mountain View, California
  12. Newport Beach, California
  13. Sacramento, California
  14. Fort Lauderdale, Florida
  15. Iowa City, Iowa
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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 MULTIPLE ASCENDING (120-HOUR, PART 2) INTRAVENOUS INFUSIONS OF PF-07304814 IN HOSPITALIZED PARTICIPANTS WITH COVID-19
Brief 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.
Detailed Description

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential 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)
Primary Purpose: Treatment
Condition  ICMJE Viral Disease
Intervention  ICMJE
  • Drug: PF-07304814
    PF-07304814 is an anti-viral, formulated for intravenous delivery
  • Drug: Placebo
    Placebo will be formulated for intravenous delivery
Study Arms  ICMJE
  • Experimental: PF-07304814

    Part 1:

    Cohort 1-5

    Part 2:

    Cohort 6-9

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

    Part 1:

    Cohort 1-5

    Part 2:

    Cohort 6-9

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 20, 2021)
72
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2020)
56
Estimated Study Completion Date  ICMJE May 19, 2021
Estimated Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Belgium,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04535167
Other Study ID Numbers  ICMJE C4611001
2020-003905-73 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP