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A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).

NCT04425538 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-04-20

Study results available
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Summary

The investigators hypothesize that early institution of TNFα inhibitor therapy in patients with severe COVID-19 infections will prevent further clinical deterioration and reduce the need for advanced cardiorespiratory support and early mortality. To address this hypothesis, a prospective, single center, phase 2 trial is proposed to assess the efficacy of infliximab or infliximab-abda in hospitalized adult patients with severe or critical COVID-19. Observations from this study will inform the conduct of prospective randomized controlled studies to follow.

Conditions

Interventions

DRUG

Infliximab

Either infliximab or infliximab-abda will be used at the discretion of the investigator

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Paul Mathew, MD · Tufts Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-01-22
Completion
2021-01-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT04425538 on ClinicalTrials.gov