Trials / Terminated
TerminatedNCT04369742
Treating COVID-19 With Hydroxychloroquine (TEACH)
Treating COVID-19 With Hydroxychloroquine: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial in Hospitalized Adults
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hydroxychloroquine (HCQ) | HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5) |
| DRUG | Placebo: Calcium citrate | Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5 |
Timeline
- Start date
- 2020-04-15
- Primary completion
- 2021-04-01
- Completion
- 2021-04-01
- First posted
- 2020-04-30
- Last updated
- 2022-04-22
- Results posted
- 2022-04-22
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04369742. Inclusion in this directory is not an endorsement.