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HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial (HERO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04352946
Recruitment Status : Not yet recruiting
First Posted : April 20, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Bradley A. Connor, M.D., GeoSentinel Foundation

Brief Summary:
This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic. 374 health care workers will be randomized at a 1:1 allocation between the intervention and placebo arms and followed for 90 days. The cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI).

Condition or disease Intervention/treatment Phase
Prophylaxis COVID-19 Health Care Worker Hydroxychloroquine Drug: Hydroxychloroquine Pre-Exposure Prophylaxis Drug: Placebo oral tablet Phase 3

Detailed Description:

This is a double-blinded, randomized placebo-controlled trial to determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily, for health care workers in the hospital reduces symptomatic and asymptomatic COVID-19 disease during the pandemic.

Secondary outcomes include 1) Adverse events; 2) Duration of symptomatic COVID-19 disease; 3) Days hospitalized attributed to COVID-19; 4) Respiratory failure attributable to COVID-19 disease requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation; 5) Mortality attributed to COVID-19 disease, and; 6) Number of days unable to work attributed to COVID-19. Laboratory markers within participants with confirmed COVID-19 will also be explored.

A total of 374 HCW will be randomized using a fixed 1:1 allocation ratio with randomization in permuted block of varying sizes from four to eight will be used to ensure equal allocation to each group. The study population will be health care workers at the New York Presbyterian Hospital - Cornell Campus and they will participate in the study for 90 days.

To determine if the intervention has been successful, the cumulative incidence of COVID-19 infection in the intervention group will be compared to the cumulative incidence of COVID-19 in the placebo group with relative (risk ratio and 95% CI) and absolute measures (risk difference and 95% CI). Investigators will also calculate adjusted risk ratios and risk differences including job class as a covariate and any other baseline clinical and demographic characteristics that are not balanced between the treatment and placebo arms using a log-binomial regression model.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: HCW are randomized to either the study drug (HCQ) or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants in the study will be randomized to either the investigational drug (HCQ) or placebo. The investigational drug and placebo will have identical appearance and be taken at the same frequency and dosage. The administration of the drug and assessment will be blinded. Study arms will be unmasked at the end of the study for the final analysis.
Primary Purpose: Prevention
Official Title: Protecting Health Care Workers From COVID-19 With Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Trial
Estimated Study Start Date : April 24, 2020
Estimated Primary Completion Date : June 24, 2020
Estimated Study Completion Date : August 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydrocholoroquine Pre-exposure prophylaxis
HCQ will be administered as 400mg orally once for 60 days.
Drug: Hydroxychloroquine Pre-Exposure Prophylaxis
HCQ PreP 400mg daily
Other Names:
  • Hydroxychloroquine PreP
  • HCQ PreP

Placebo Comparator: Placebo
Placebo will be administered as 400mg orally once for 60 days.
Drug: Placebo oral tablet
Placebo tablets 400mg daily
Other Name: Placebo




Primary Outcome Measures :
  1. Cumulative Incidence of COVID-19 Infection [ Time Frame: 90 days ]
    Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers


Secondary Outcome Measures :
  1. Adverse events incidence [ Time Frame: 90 days ]
    Incidence of reported and grade of adverse events

  2. Duration of symptomatic COVID-19 disease [ Time Frame: 90 days ]
    Duration in days of symptomatic COVID-19 disease in HCW who had disease

  3. Days hospitalized attributed to COVID-19 [ Time Frame: 90 days ]
    Duration in days of hospitalization attributed to COVID-19 disease in HCW who had disease

  4. Number or respiratory failure attributable to COVID-19 disease [ Time Frame: 90 days ]
    Number of HCW with respiratory failure attributable to COVID-19 disease requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation in HCW who developed disease

  5. Mortality Incidence [ Time Frame: 90 days ]
    Cumulative Incidence of Mortality attributed to COVID-19 disease in HCW who developed disease

  6. Days of work lost [ Time Frame: 90 days ]
    Number of days unable to work attributed to COVID-19 in HCW who developed disease


Other Outcome Measures:
  1. Proportion of HCW with plasma able to neutralize SARS-CoV-2 virus [ Time Frame: 90 days ]
    Proportion of participants with plasma able to neutralize SARS-CoV-2 virus (plaque reduction neutralization test) in vitro.

  2. Number of participants with severity markers of host immune and endothelial activation [ Time Frame: 90 days ]
    Number of participants with severity markers of host immune and endothelial activation measured at clinical presentation and their ability to predict severity and outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Health care worker (HCW) at the hospital who work on a "full time" basis during the study period. For the purposes of the study, "health care workers" are physicians, nurses, nurse practitioners, physician assistants, respiratory therapists, X-ray technicians, social workers and support staff (including but not limited to house-keeping, and porters).
  2. Age ≥18 years.
  3. Ability to communicate with study staff in English

Exclusion Criteria:

  1. Known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds.
  2. Current use of hydroxychloroquine for the treatment of a medical condition.
  3. Known prolonged QT syndrome, or concomitant medications which simultaneously may prolong the QTC that cannot be temporarily suspended/replaced. These are including but not limited to Class IA, IC and III antiarrhythmics; certain antidepressants, antipsychotics, and anti-infectives; domperidone; 5-hydroxytryptamine (5-HT)3 receptor antagonists; kinase inhibitors; histone deacetylase inhibitors beta-2 adrenoceptor agonists.
  4. Known pre-existing retinopathy of the eye.
  5. Disclosure of self-administered use of hydroxychloroquine or chloroquine currently under investigation <4 weeks prior to study. This window is intended to account for the drug half-life of HCQ (21 days).
  6. Baseline symptom of COVID-19 disease at enrollment and baseline viral detection specimen positive for SARS-COV-2. All participants with COVID-19 symptoms at enrollment will be directed to have confirmatory testing (within the department or occupational health as per the site guidelines). Participants who are negative for SARS-COV-2 will be redirected to enrollment procedures, those testing positive will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352946


Contacts
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Contact: Bradley A Connor, MD 9172138998 bconnor1@gmail.com
Contact: Marina Rogova, RN 8434247542 marina.rogova@connormd.com

Locations
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United States, New York
The New York Center for Travel and Tropical Medicine
New York, New York, United States, 10022
Contact: Bradley A Connor, MD    212-988-2800    bconnor1@gmail.com   
Contact: Marina Rogova, RN    8434247542    marina.rogova@connormd.com   
Sub-Investigator: William MacLeod, ScD         
Sub-Investigator: Robert S Brown, Jr, MD         
Sub-Investigator: Kevin Kain, MD         
Sub-Investigator: Megan Landes, MD         
Sponsors and Collaborators
GeoSentinel Foundation
Investigators
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Principal Investigator: Bradley A Connor, MD Dr. Bradley A. Connor
Additional Information:
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Responsible Party: Bradley A. Connor, M.D., Clinical Professor of Medicine, Weill Cornell Medicine, GeoSentinel Foundation
ClinicalTrials.gov Identifier: NCT04352946    
Other Study ID Numbers: GFICOVID-19-1
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: supporting made available to other researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: From July 1, 2020 until December 31, 2020
Access Criteria: from our web site
URL: http://www.geosentinel.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents