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NCT04425538 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).
A Phase 2 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT04425538: Completed Phase 2 study, sponsored by Tufts Medical Center.
NCT04425538 is a Phase 2 study that has completed, run by Tufts Medical Center. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04425538, a Phase 2 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
Time to improvement in oxygenation (increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2)
Interventions
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2021-01-22 |
| Phase | Phase 2 |
What the finished NCT04425538 record still lists
NCT04425538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Infliximab is the first listed.
NCT04425538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04425538 about?
NCT04425538 is a clinical study titled "A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).". 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 cen...
What is the current status of trial NCT04425538?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2020-06-01. Estimated completion is 2021-01-22.
What interventions are being tested in trial NCT04425538?
The interventions under investigation include: Infliximab (DRUG).
Who is sponsoring clinical trial NCT04425538?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04425538's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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