MedTrace Logo

Treating COVID-19 With Hydroxychloroquine (TEACH)

NCT04369742 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2022-04-22

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • State University of New York - Downstate Medical Center

    collaborator OTHER

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Mark Mulligan, MD, FIDSA · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2021-04-01
Completion
2021-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT04369742 on ClinicalTrials.gov