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Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia

NCT04469114 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2021-08-09

No results posted yet for this study

Summary

Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to progression to more severe lung disease and acute respiratory distress syndrome (ARDS) in patients with COVID-19. The purpose of the study is to assess the safety and efficacy of tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized participants with COVID-19 pneumonia.

Conditions

  • Covid19

Interventions

DRUG

Tofacitinib 10 mg

Tofacitinib 10mg administered orally twice daily for 14 days or until hospital discharge

DRUG

Placebo

Tofacitinib-matching placebo administered orally twice daily for 14 days or until hospital discharge

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Hospital Israelita Albert Einstein

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2021-01-09
Completion
2021-01-09
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04469114 on ClinicalTrials.gov