chouV

NCT Number

NCT********

NCT********

Page 1

chouV

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

Page 2

chouV

Study URL Acronym Study Status

https://beta.clinicaltrials.gov/study/NCT04412252 WITHDRAWN

https://beta.clinicaltrials.gov/study/NCT04368728 COMPLETED

Page 3

chouV

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

Page 4

chouV

Study Results Conditions

NO COVID-19

NO SARS-CoV-2 Infection COVID-19

Page 5

chouV

Interventions

DRUG: Tofacitinib OTHER: Placebo

BIOLOGICAL: BNT162b1 BIOLOGICAL: BNT162b2 OTHER: Placebo BIOLOGICAL: BNT162b2SA

Page 6

chouV

Primary

Clinical

Percenta

Page 7

chouV

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

Page 8

chouV

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

Page 9

chouV

Phases Funder Type Study Type

PHASE2 INDUSTRY INTERVENTIONAL

PHASE2 PHASE3 INDUSTRY INTERVENTIONAL

Page 10

chouV

Study Design

Allocation: RANDOMIZED Intervention Model: PARALLEL Masking: DOUBLE (PARTICIPANT, INVESTIGATOR) Primary Purp

Allocation: RANDOMIZED Intervention Model: PARALLEL Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGA

Page 11

chouV

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

Page 12

chouV

Results First Posted Last Update Posted

2020-07-31

2023-02-28

Page 13

chouV

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

Page 14

chouV

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

Page 15

chouV

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

Page 16

chouV

for American Indian Health, Chinle, Arizona, 86503, United States The Pain Center of Arizona, Phoenix, Arizona, 85018, United States HO

Page 17

chouV

nix, Arizona, 85018, United States HOPE Research Institute, Phoenix, Arizona, 85023, United States Alliance for Multispecialty Research, L

Page 18

chouV

Alliance for Multispecialty Research, LLC, Tempe, Arizona, 85281, United States Whiteriver Indian Hospital, Whiteriver, Arizona, 85941, Unit

Page 19

chouV

spital, Whiteriver, Arizona, 85941, United States Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States Collaborative Neur

Page 20

chouV

801, United States Collaborative Neuroscience Research, LLC, Long Beach, California, 90806, United States Long Beach Clinical Trials Se

Page 21

chouV

d States Long Beach Clinical Trials Services Inc., Long Beach, California, 90806, United States Kaiser Permanente Los Angeles Medical Ce

Page 22

chouV

r Permanente Los Angeles Medical Center, Los Angeles, California, 90027, United States National Research Institute, Los Angeles, Californ

Page 23

chouV

search Institute, Los Angeles, California, 90057, United States Velocity Clinical Research, North Hollywood, North Hollywood, California, 91

Page 24

chouV

ywood, North Hollywood, California, 91606, United States Paradigm Clinical Research Center, Redding, California, 96001, United States Ka

Page 25

chouV

g, California, 96001, United States Kaiser Permanente Sacramento, Sacramento, California, 95815, United States Clinical and Translationa

Page 26

chouV

United States Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC), Sacramento, California, 95817, United S

Page 27

chouV

cramento, California, 95817, United States UC Davis Medical Center, Sacramento, California, 95817, United States California Research Fo

Page 28

chouV

United States California Research Foundation, San Diego, California, 92123-1881, United States Kaiser Permanente Santa Clara, Santa C

Page 29

chouV

ser Permanente Santa Clara, Santa Clara, California, 95051, United States Bayview Research Group, Valley Village, California, 91607, Uni

Page 30

chouV

, Valley Village, California, 91607, United States Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States Lynn Institut

Page 31

chouV

nia, 94598, United States Lynn Institute of Denver, Aurora, Colorado, 80012, United States Clinical Research Consulting, LLC, Milford, Con

Page 32

chouV

esearch Consulting, LLC, Milford, Connecticut, 06460, United States Yale Center for Clinical Investigations (CSRU), New Haven, Connecticu

Page 33

chouV

tions (CSRU), New Haven, Connecticut, 06519, United States Alliance for Multispecialty Research, Coral Gables, Florida, 33134, United St

Page 34

chouV

oral Gables, Florida, 33134, United States DeLand Clinical Research Unit, DeLand, Florida, 32720, United States Fleming Island Center for

Page 35

chouV

nited States Fleming Island Center for Clinical Research, Fleming Island, Florida, 32003, United States Indago Research & Health Center, I

Page 36

Contact this candidate