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.
NCT ID: NCT04535167
Last Updated: 2023-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2020-09-09
2021-06-07
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
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.
TREATMENT
TRIPLE
Study Groups
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PF-07304814
Part 1:
Cohort 1-5
Part 2:
Cohort 6-9
PF-07304814
PF-07304814 is an anti-viral, formulated for intravenous delivery
Placebo
Part 1:
Cohort 1-5
Part 2:
Cohort 6-9
Placebo
Placebo will be formulated for intravenous delivery
Interventions
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PF-07304814
PF-07304814 is an anti-viral, formulated for intravenous delivery
Placebo
Placebo will be formulated for intravenous delivery
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
79 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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El Camino Health
Mountain View, California, United States
Palo Alto Medical Foundation
Mountain View, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
UC Davis Health Investigational Drug Pharmacy
Sacramento, California, United States
UC Davis Medical Center
Sacramento, California, United States
Massachusetts General Hospital Translational and Clinical Research Center
Boston, Massachusetts, United States
Massachusetts General Hospital, Clinical Trials Pharmacy
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Regional One Health
Memphis, Tennessee, United States
University Hospital Brugmann
Brussels, , Belgium
Santa Casa De Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Countries
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References
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Robinson P, Toussi SS, Aggarwal S, Bergman A, Zhu T, Hackman F, Sathish JG, Updyke L, Loudon P, Krishna G, Clevenbergh P, Hernandez-Mora MG, Cisneros Herreros JM, Albertson TE, Dougan M, Thacker A, Baniecki ML, Soares H, Whitlock M, Nucci G, Menon S, Anderson AS, Binks M. Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Intravenous Infusions of PF-07304814 (Lufotrelvir) in Participants Hospitalized With COVID-19. Open Forum Infect Dis. 2023 Jul 10;10(8):ofad355. doi: 10.1093/ofid/ofad355. eCollection 2023 Aug.
Crosas-Molist E, Samain R, Kohlhammer L, Orgaz JL, George SL, Maiques O, Barcelo J, Sanz-Moreno V. Rho GTPase signaling in cancer progression and dissemination. Physiol Rev. 2022 Jan 1;102(1):455-510. doi: 10.1152/physrev.00045.2020. Epub 2021 Sep 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2020-003905-73
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4611001
Identifier Type: -
Identifier Source: org_study_id
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