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Treating COVID-19 With Hydroxychloroquine (TEACH)

Primary Purpose

COVID-19

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Hydroxychloroquine (HCQ)

Placebo: Calcium citrate

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria

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.

Sites / Locations

State University of New York (SUNY) Downstate Medical Center
NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydroxychloroquine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent of Participants With SAE Through Day 30

The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100)

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)

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)

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).

Secondary Outcome Measures

Hospital Length of Stay

LOS is defined as the interval (in days) that the patient was admitted to a non-rehabilitation floor, categorized as short (<7 days), moderate (7-10 days), or extended (>10 days)

Days of Fever

Defined as number of days with temperature >100.4 degrees Fahrenheit.

Days of Non-invasive Ventilator Use

Defined as days the patient is placed on non-invasive ventilator support (CPAP or BiPAP), excluding routine CPAP use for sleep apnea.

Days of Non-rebreather Mask Oxygen Supplementation

Defined as the number of days the subject was on a non-rebreather mask.

Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale

Grade 1 (mild) = able to be managed with nonparenteral supportive care, Grade 2 (moderate) = at least one of the following present (hospitalization needed for management of CRS-related symptoms, parenteral nutrition or supportive care required, signs of moderate/severe organ dysfunction), Grade 3 (severe) = hospitalization needed for management of at least one of the following (hypotension, hypoxia, organ dysfunction, coagulopathy), Grade 4 (life-threatening) = at least one of the following present (hypotension requiring high-dose vasopressors, hypoxia requiring mechanical ventilation).

Percent of Subjects With Q-T Interval, Corrected (qTC) Prolongation at End of Treatment (EOT)

(≥470 milliseconds in men; ≥480 milliseconds in women) on electrocardiogram at EOT (Day 6)

Percent of Patients Who Resulted in Mortality

Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100).

Percent of Participants Who Required ICU Admission

Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100).

Percent of Participants Who Required Invasive Mechanical Ventilation

Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100).

Percent of Participants Who Required Extracorporeal Membrane Oxygenation (ECMO)

Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100).

Percent of Participants With Hypotension Requiring Vasopressor Support

Individual component of severe disease progression composite endpoint evaluated. For incidence, the measure value is reported as a percentage (# of patients with outcome/ # of patients * 100)

Percent of Participants With SARS-CoV-2 Viral Eradication From Nasopharyngeal Specimens at EOT

Laboratory endpoint, measured by RT-PCR, reported as the percentage of negative results at day 6

Change in Alanine Aminotransferase (ALT) Levels

Biochemistry lab-work will be completed to obtain ALT levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Change in Aspartate Aminotransferase (AST) Levels

Biochemistry lab-work will be completed to obtain AST levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Change in Creatinine Levels

Biochemistry lab-work will be completed to obtain Creatinine levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Change in Glucose Levels

Biochemistry lab-work will be completed to obtain Glucose levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Change in White Blood Cell (WBC) Count

Hematology lab-work will be completed to obtain WBC count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Change in Hemoglobin Levels

Hematology lab-work will be completed to obtain hemoglobin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Change in Platelet Count

Hematology lab-work will be completed to obtain platelet count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Change in Total Bilirubin Levels

Biochemistry lab-work will be completed to obtain bilirubin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Change in Lactate Dehydrogenase (LDH) Levels

Biochemistry lab-work will be completed to obtain LDH levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Change in C-Reactive Protein (CRP) Levels

Biochemistry lab-work will be completed to obtain CRP levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Change in Interleukin 6 (IL-6) Levels

Biochemistry lab-work will be completed to obtain IL-6 levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).

Full Information

NCT ID

NCT04369742

First Posted

April 25, 2020

Last Updated

April 20, 2022

Sponsor

NYU Langone Health

Collaborators

State University of New York - Downstate Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04369742

Brief Title

Treating COVID-19 With Hydroxychloroquine (TEACH)

Official Title

Treating COVID-19 With Hydroxychloroquine: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial in Hospitalized Adults

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Terminated

Why Stopped

Investigator decision

Study Start Date

April 15, 2020 (Actual)

Primary Completion Date

April 1, 2021 (Actual)

Study Completion Date

April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

State University of New York - Downstate Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Placebo-controlled, Randomized

Masking

ParticipantCare Provider

Masking Description

Double-blind

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydroxychloroquine

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Hydroxychloroquine (HCQ)

Intervention Description

HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)

Intervention Type

Drug

Intervention Name(s)

Placebo: Calcium citrate

Intervention Description

Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5

Primary Outcome Measure Information:

Title

Percent of Participants With SAE Through Day 30

Description

The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100)

Time Frame

30 days

Title

Percent of Participants With Grade 3 or 4 AEs Through Day 30

Description

The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100)

Time Frame

30 days

Title

Percent of Participants With Discontinuation of Therapy (for Any Reason)

Description

The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100)

Time Frame

30 days

Title

Percent of Participants Showing a Severe Disease Progression Composite Outcome

Description

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Hospital Length of Stay

Description

LOS is defined as the interval (in days) that the patient was admitted to a non-rehabilitation floor, categorized as short (<7 days), moderate (7-10 days), or extended (>10 days)

Time Frame

30 days

Title

Days of Fever

Description

Defined as number of days with temperature >100.4 degrees Fahrenheit.

Time Frame

14 days

Title

Days of Non-invasive Ventilator Use

Description

Defined as days the patient is placed on non-invasive ventilator support (CPAP or BiPAP), excluding routine CPAP use for sleep apnea.

Time Frame

14 days

Title

Days of Non-rebreather Mask Oxygen Supplementation

Description

Defined as the number of days the subject was on a non-rebreather mask.

Time Frame

14 days

Title

Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale

Description

Time Frame

Day 1

Title

Percent of Subjects With Q-T Interval, Corrected (qTC) Prolongation at End of Treatment (EOT)

Description

(≥470 milliseconds in men; ≥480 milliseconds in women) on electrocardiogram at EOT (Day 6)

Time Frame

6 Days

Title

Percent of Patients Who Resulted in Mortality

Description

Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100).

Time Frame

30 days

Title

Percent of Participants Who Required ICU Admission

Description

Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100).

Time Frame

30 Days

Title

Percent of Participants Who Required Invasive Mechanical Ventilation

Description

Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100).

Time Frame

30 Days

Title

Percent of Participants Who Required Extracorporeal Membrane Oxygenation (ECMO)

Description

Individual component of severe disease progression composite endpoint evaluated. The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100).

Time Frame

30 Days

Title

Percent of Participants With Hypotension Requiring Vasopressor Support

Description

Individual component of severe disease progression composite endpoint evaluated. For incidence, the measure value is reported as a percentage (# of patients with outcome/ # of patients * 100)

Time Frame

30 Days

Title

Percent of Participants With SARS-CoV-2 Viral Eradication From Nasopharyngeal Specimens at EOT

Description

Laboratory endpoint, measured by RT-PCR, reported as the percentage of negative results at day 6

Time Frame

6 days

Title

Change in Alanine Aminotransferase (ALT) Levels

Description

Time Frame

Baseline, 6 days

Title

Change in Aspartate Aminotransferase (AST) Levels

Description

Time Frame

Baseline, 6 days

Title

Change in Creatinine Levels

Description

Time Frame

Baseline, 6 days

Title

Change in Glucose Levels

Description

Time Frame

Baseline, 6 days

Title

Change in White Blood Cell (WBC) Count

Description

Time Frame

Baseline, 6 days

Title

Change in Hemoglobin Levels

Description

Time Frame

Baseline, 6 days

Title

Change in Platelet Count

Description

Time Frame

Baseline, 6 days

Title

Change in Total Bilirubin Levels

Description

Time Frame

Baseline, 6 days

Title

Change in Lactate Dehydrogenase (LDH) Levels

Description

Time Frame

Baseline, 6 days

Title

Change in C-Reactive Protein (CRP) Levels

Description

Time Frame

Baseline, 6 days

Title

Change in Interleukin 6 (IL-6) Levels

Description

Time Frame

Baseline, 6 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Mulligan, MD, FIDSA

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

State University of New York (SUNY) Downstate Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11203

Country

United States

Facility Name

NYU Langone Health

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

Requests should be directed to mark.mulligan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Treating COVID-19 With Hydroxychloroquine (TEACH)

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