Clinical Research Part Time
Resume:
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NCT Number
NCT********
NCT********
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Study Title
Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Hea
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Study URL Acronym Study Status
https://beta.clinicaltrials.gov/study/NCT04412252 WITHDRAWN
https://beta.clinicaltrials.gov/study/NCT04368728 COMPLETED
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Brief Summary
The study is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel group study of the safety and e
Participants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR or other commercially available
Eligible participants will be randomized on Day 1 in a 1:1 ratio to the tofacitinib treatment group or the placebo treatment group
Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up v
An independent, external DSMB will be convened to oversee the safety of participants and make recommendations regarding
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy
The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded c
The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates agains
* As a 2-dose (separated by 21 days) schedule;
* At various different dose levels in Phase 1;
* As a booster;
* In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: â ¥12 years of age \[stratified as 12-15,
The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg.
Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of th
In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, a
The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who wi
To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of
To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet spec
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Study Results Conditions
NO COVID-19
NO SARS-CoV-2 Infection COVID-19
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Interventions
DRUG: Tofacitinib OTHER: Placebo
BIOLOGICAL: BNT162b1 BIOLOGICAL: BNT162b2 OTHER: Placebo BIOLOGICAL: BNT162b2SA
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Primary
Clinical
Percenta
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Secondary Outcome Measures
Clinical status using ordinal scale, Ordinal scale of disease severity. The scale is as follows: 1) Death; 2) Hospitalized, o
In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs, As measured at the central lab
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Other Outcome Measures Sponsor Collaborators Sex Age
s follows: 1) Death; 2) Hospitalized, o Pfizer ALL ADULT, OLDER_ADULT
d as GMTs, As measured at the central labor
BioNTech SE Pfizer ALL CHILD, ADULT, OLDER_ADULT
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Phases Funder Type Study Type
PHASE2 INDUSTRY INTERVENTIONAL
PHASE2 PHASE3 INDUSTRY INTERVENTIONAL
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Study Design
Allocation: RANDOMIZED Intervention Model: PARALLEL Masking: DOUBLE (PARTICIPANT, INVESTIGATOR) Primary Purp
Allocation: RANDOMIZED Intervention Model: PARALLEL Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGA
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Other IDs Start Date Primary Completion Date Completion Date First Posted
A3921377 2020-07-06 2020-09-16 2020-10-18 2020-06-02
C4591001 202*-******-** 2020-04-29 2023-02-10 2023-02-10 2020-04-30
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Results First Posted Last Update Posted
2020-07-31
2023-02-28
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Locations
Hartford Hospital (HH), Hartford, Connecticut, 06102, United States University of Iowa Hospitals & Clinics Investigational Drug
North Alabama Research Center, LLC, Athens, Alabama, 35611, United States Birmingham Clinical Research Unit, Birmingha
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Study Documents
United States Ochsner LSU Health Shreveport Academic Medical Center, Shreveport, Louisiana, 71103, United States University Hospitals
35802, United States Alliance for Multispecialty Research, LLC, Mobile, Alabama, 36608, United States Chinle Comprehensive Health Care
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ited States University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States
nle Comprehensive Health Care Facility, Chinle, Arizona, 86503, United States Johns Hopkins Center for American Indian Health, Chinle, A
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for American Indian Health, Chinle, Arizona, 86503, United States The Pain Center of Arizona, Phoenix, Arizona, 85018, United States HO
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nix, Arizona, 85018, United States HOPE Research Institute, Phoenix, Arizona, 85023, United States Alliance for Multispecialty Research, L
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Alliance for Multispecialty Research, LLC, Tempe, Arizona, 85281, United States Whiteriver Indian Hospital, Whiteriver, Arizona, 85941, Unit
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spital, Whiteriver, Arizona, 85941, United States Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States Collaborative Neur
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801, United States Collaborative Neuroscience Research, LLC, Long Beach, California, 90806, United States Long Beach Clinical Trials Se
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d States Long Beach Clinical Trials Services Inc., Long Beach, California, 90806, United States Kaiser Permanente Los Angeles Medical Ce
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r Permanente Los Angeles Medical Center, Los Angeles, California, 90027, United States National Research Institute, Los Angeles, Californ
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search Institute, Los Angeles, California, 90057, United States Velocity Clinical Research, North Hollywood, North Hollywood, California, 91
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ywood, North Hollywood, California, 91606, United States Paradigm Clinical Research Center, Redding, California, 96001, United States Ka
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g, California, 96001, United States Kaiser Permanente Sacramento, Sacramento, California, 95815, United States Clinical and Translationa
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United States Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC), Sacramento, California, 95817, United S
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cramento, California, 95817, United States UC Davis Medical Center, Sacramento, California, 95817, United States California Research Fo
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United States California Research Foundation, San Diego, California, 92123-1881, United States Kaiser Permanente Santa Clara, Santa C
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ser Permanente Santa Clara, Santa Clara, California, 95051, United States Bayview Research Group, Valley Village, California, 91607, Uni
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, Valley Village, California, 91607, United States Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States Lynn Institut
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nia, 94598, United States Lynn Institute of Denver, Aurora, Colorado, 80012, United States Clinical Research Consulting, LLC, Milford, Con
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esearch Consulting, LLC, Milford, Connecticut, 06460, United States Yale Center for Clinical Investigations (CSRU), New Haven, Connecticu
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tions (CSRU), New Haven, Connecticut, 06519, United States Alliance for Multispecialty Research, Coral Gables, Florida, 33134, United St
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oral Gables, Florida, 33134, United States DeLand Clinical Research Unit, DeLand, Florida, 32720, United States Fleming Island Center for
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nited States Fleming Island Center for Clinical Research, Fleming Island, Florida, 32003, United States Indago Research & Health Center, I
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