Study Stopped
Investigator decision
Treating COVID-19 With Hydroxychloroquine (TEACH)
1 other identifier
interventional
128
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Apr 2020
Typical duration for phase_2 covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2020
CompletedFirst Submitted
Initial submission to the registry
April 25, 2020
CompletedFirst Posted
Study publicly available on registry
April 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedResults Posted
Study results publicly available
April 22, 2022
CompletedApril 22, 2022
April 1, 2022
12 months
April 25, 2020
March 31, 2022
April 20, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Percent of Participants With SAE Through Day 30
The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100)
30 days
Percent of Participants With Grade 3 or 4 AEs Through Day 30
The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100)
30 days
Percent of Participants With Discontinuation of Therapy (for Any Reason)
The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100)
30 days
Percent of Participants Showing a Severe Disease Progression Composite Outcome
Including any of the following: mortality, ICU admission, invasive mechanical ventilation, ECMO, and/or hypotension requiring vasopressor support by the 14-day post-treatment evaluation (PTE). The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100).
14 days
Secondary Outcomes (23)
Hospital Length of Stay
30 days
Days of Fever
14 days
Days of Non-invasive Ventilator Use
14 days
Days of Non-rebreather Mask Oxygen Supplementation
14 days
Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale
Day 1
- +18 more secondary outcomes
Study Arms (2)
Hydroxychloroquine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)
Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
Eligibility Criteria
You may qualify if:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Hospitalized adult (≥18 years old) with symptoms consistent with COVID-19 including but not limited to any of the following: fever (documented or subjective), cough, dyspnea, diarrhea, nausea, diffuse myalgias, and/or anosmia
- Informed consent signed by patient
- Positive SARS-CoV-2 RT-PCR testing (nasopharyngeal, oropharyngeal, sputum and/or bronchoalveolar lavage) o The testing may:
- Occur up to ≤72h prior to informed consent of participation in the study
- Be undertaken either on-site or in an external laboratory certified by New York State to run testing for SARS-CoV-2
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Presence of the primary endpoint (ICU admission, mechanical ventilation, ECMO, and/or vasopressor requirement) at time of randomization.
- Treatment with CQ or HCQ within the 30 days prior to the start of the study drug treatment.
- Participation in a clinical trial to investigate a non-FDA approved drug with the intent to treat SARS-CoV-2 within the 30 days prior to the start of the study drug treatment.
- Unable to take oral medications.
- History of allergic reaction or intolerance to CQ or HCQ.
- Baseline corrected qT interval \>470 milliseconds (male) or \>480 milliseconds (female), history of congenital qT prolongation, and/or history of cardiac arrest.
- Concomitant therapy with flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, or pimozide
- History of retinal disease including a documented history of diabetic retinopathy.
- Known history of G6PD deficiency.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
State University of New York (SUNY) Downstate Medical Center
Brooklyn, New York, 11203, United States
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Mulligan, MD
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Mulligan, MD, FIDSA
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2020
First Posted
April 30, 2020
Study Start
April 15, 2020
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
April 22, 2022
Results First Posted
April 22, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- Requests should be directed to mark.mulligan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[contact information for PI or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.