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NCT04369742 · ClinicalTrials.gov registry record · Phase 2
Treating COVID-19 With Hydroxychloroquine (TEACH)
A Phase 2 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT04369742 is a Phase 2 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 128 participants.
The verdict
NCT04369742, a Phase 2 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study Summary
Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data suggesting a possible antiviral effect. However, HCQ's effect on COVID-19 in human infection remains unknown. To fill this knowledge gap, we will enroll 626 adult patients hospitalized with laboratory-confirmed COVID-19 and randomize them 1:1 to a five-day course of HCQ or placebo. Notable exclusion criteria include ICU admission or ventilation on enrollment, prior therapy with HCQ, and baseline prolonged qTC. Our primary endpoint is a severe disease progression composite outcome (death, ICU admission, mechanical ventilation, ECMO, , and/or vasopressor requirement) at the 14-day post-treatment evaluation. Notable secondary clinical outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support, and cytokine release syndrome (CRS) grading scale. Secondary exploratory objectives will examine SARS-CoV-2 viral eradication at the EOT, changes in COVID-19 putative prognostic markers and cytokine levels, and titers of anti-SARS-CoV-2 antibodies. This randomized trial will determine if HCQ is effective as treatment in hospitalized non-ICU patients with COVID-19.
Interventions
- DRUG Hydroxychloroquine (HCQ)
- DRUG Placebo: Calcium citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2020-04-15 |
| Est. Completion | 2021-04-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04369742
The ClinicalTrials.gov registry entry for NCT04369742 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hydroxychloroquine (HCQ) is the first listed.
NCT04369742 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04369742 about?
NCT04369742 is a clinical study titled "Treating COVID-19 With Hydroxychloroquine (TEACH)". Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data suggesting a possible antiviral effect. However, HCQ's effect on COVID-19 in human infection remains unknown. To fill this...
What is the current status of trial NCT04369742?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2020-04-15. Estimated completion is 2021-04-01.
What interventions are being tested in trial NCT04369742?
The interventions under investigation include: Hydroxychloroquine (HCQ) (DRUG), Placebo: Calcium citrate (DRUG).
Who is sponsoring clinical trial NCT04369742?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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