COVID-19Phase 2NCT04369742
Treating COVID-19 With Hydroxychloroquine (TEACH)
A Phase 2 study testing Hydroxychloroquine (HCQ) in people with COVID-19, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine (HCQ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2020to 1 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
State University of New York (SUNY) Downstate Medical Center
Brooklyn, New York, 11203
NYU Langone Health
New York, New York, 10016
About this study
Official title: Treating COVID-19 With Hydroxychloroquine: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial in Hospitalized Adults
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
- COVID-19
- Being tested
- Hydroxychloroquine (HCQ), Placebo: Calcium citrate
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine (HCQ)Drug
HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)
Placebo: Calcium citrateDrug
Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Not described Receives: Drug: Hydroxychloroquine (HCQ) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo: Calcium citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With SAE Through Day 30
The measure value is reported as a percentage (# of patients with outcome/ # of patients * 100)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 14 days
Secondary outcomes (23)
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)
Measured: 30 days
Days of Fever
Defined as number of days with temperature >100.4 degrees Fahrenheit.
Measured: 14 days
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.
Measured: 14 days
Days of Non-rebreather Mask Oxygen Supplementation
Defined as the number of days the subject was on a non-rebreather mask.
Measured: 14 days
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).
Measured: Day 1
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)
Measured: 6 Days
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).
Measured: 30 days
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).
Measured: 30 Days
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).
Measured: 30 Days
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).
Measured: 30 Days
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)
Measured: 30 Days
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
Measured: 6 days
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).
Measured: Baseline, 6 days
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).
Measured: Baseline, 6 days
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).
Measured: Baseline, 6 days
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).
Measured: Baseline, 6 days
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).
Measured: Baseline, 6 days
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).
Measured: Baseline, 6 days
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).
Measured: Baseline, 6 days
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).
Measured: Baseline, 6 days
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).
Measured: Baseline, 6 days
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).
Measured: Baseline, 6 days
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).
Measured: Baseline, 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start15 Apr 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Why it stopped: Investigator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled, Randomized
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center
- Responsible party
- Sponsor
- Investigators
- Mark Mulligan, MD, FIDSA, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369742
- Sponsor's protocol ID
- 20-00463
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2020
- Last updated
- 22 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating COVID-19 With Hydroxychloroquine: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial in Hospitalized Adults
- ClinicalTrials.gov ID
- NCT04369742
- Acronym / sponsor ID
- 20-00463
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator decision
- Enrolment
- 128 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Posted 22 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Placebo-controlled, Randomized
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: Hydroxychloroquine (HCQ) |
| Placebo | Placebo comparator | Drug: Placebo: Calcium citrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine (HCQ)HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5) | Drug | Hydroxychloroquine |
| Placebo: Calcium citrateCalcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5 | Drug | Placebo |
Primary outcome
Percent of Participants With SAE Through Day 30
Time frame: 30 days
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
Time frame: 30 days
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)
Time frame: 30 days
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
Time frame: 14 days
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).
23 secondary outcomes
Hospital Length of Stay
Time frame: 30 days
Days of Fever
Time frame: 14 days
Days of Non-invasive Ventilator Use
Time frame: 14 days
Days of Non-rebreather Mask Oxygen Supplementation
Time frame: 14 days
Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale
Time frame: Day 1
Percent of Subjects With Q-T Interval, Corrected (qTC) Prolongation at End of Treatment (EOT)
Time frame: 6 Days
Percent of Patients Who Resulted in Mortality
Time frame: 30 days
Percent of Participants Who Required ICU Admission
Time frame: 30 Days
Percent of Participants Who Required Invasive Mechanical Ventilation
Time frame: 30 Days
Percent of Participants Who Required Extracorporeal Membrane Oxygenation (ECMO)
Time frame: 30 Days
Percent of Participants With Hypotension Requiring Vasopressor Support
Time frame: 30 Days
Percent of Participants With SARS-CoV-2 Viral Eradication From Nasopharyngeal Specimens at EOT
Time frame: 6 days
Change in Alanine Aminotransferase (ALT) Levels
Time frame: Baseline, 6 days
Change in Aspartate Aminotransferase (AST) Levels
Time frame: Baseline, 6 days
Change in Creatinine Levels
Time frame: Baseline, 6 days
Change in Glucose Levels
Time frame: Baseline, 6 days
Change in White Blood Cell (WBC) Count
Time frame: Baseline, 6 days
Change in Hemoglobin Levels
Time frame: Baseline, 6 days
Change in Platelet Count
Time frame: Baseline, 6 days
Change in Total Bilirubin Levels
Time frame: Baseline, 6 days
Change in Lactate Dehydrogenase (LDH) Levels
Time frame: Baseline, 6 days
Change in C-Reactive Protein (CRP) Levels
Time frame: Baseline, 6 days
Change in Interleukin 6 (IL-6) Levels
Time frame: Baseline, 6 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Mulligan, MD, FIDSA principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine (HCQ) in people with COVID-19, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants With SAE Through Day 30 (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.