Back to resultsHEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial (HERO)
Primary Purpose
Prophylaxis, COVID-19, Health Care Worker
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine Pre-Exposure Prophylaxis
Placebo oral tablet
Sponsored by
About this trial
This is an interventional prevention trial for Prophylaxis
Eligibility Criteria
Inclusion Criteria:
- 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).
- Age ≥18 years.
- Ability to communicate with study staff in English
Exclusion Criteria:
- Known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds.
- Current use of hydroxychloroquine for the treatment of a medical condition.
- 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.
- Known pre-existing retinopathy of the eye.
- 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).
- 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.
Sites / Locations
- The New York Center for Travel and Tropical Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydrocholoroquine Pre-exposure prophylaxis
Placebo
Arm Description
HCQ will be administered as 400mg orally once for 60 days.
Placebo will be administered as 400mg orally once for 60 days.
Outcomes
Primary Outcome Measures
Cumulative Incidence of COVID-19 Infection
Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers
Secondary Outcome Measures
Adverse events incidence
Incidence of reported and grade of adverse events
Duration of symptomatic COVID-19 disease
Duration in days of symptomatic COVID-19 disease in HCW who had disease
Days hospitalized attributed to COVID-19
Duration in days of hospitalization attributed to COVID-19 disease in HCW who had disease
Number or respiratory failure attributable to COVID-19 disease
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
Mortality Incidence
Cumulative Incidence of Mortality attributed to COVID-19 disease in HCW who developed disease
Days of work lost
Number of days unable to work attributed to COVID-19 in HCW who developed disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04352946
Brief Title
HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial
Acronym
HERO
Official Title
Protecting Health Care Workers From COVID-19 With Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2020 (Anticipated)
Primary Completion Date
June 24, 2020 (Anticipated)
Study Completion Date
August 24, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
GeoSentinel Foundation
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis, COVID-19, Health Care Worker, Hydroxychloroquine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
HCW are randomized to either the study drug (HCQ) or placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
374 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrocholoroquine Pre-exposure prophylaxis
Arm Type
Experimental
Arm Description
HCQ will be administered as 400mg orally once for 60 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered as 400mg orally once for 60 days.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Pre-Exposure Prophylaxis
Other Intervention Name(s)
Hydroxychloroquine PreP, HCQ PreP
Intervention Description
HCQ PreP 400mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Other Intervention Name(s)
Placebo
Intervention Description
Placebo tablets 400mg daily
Primary Outcome Measure Information:
Title
Cumulative Incidence of COVID-19 Infection
Description
Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Adverse events incidence
Description
Incidence of reported and grade of adverse events
Time Frame
90 days
Title
Duration of symptomatic COVID-19 disease
Description
Duration in days of symptomatic COVID-19 disease in HCW who had disease
Time Frame
90 days
Title
Days hospitalized attributed to COVID-19
Description
Duration in days of hospitalization attributed to COVID-19 disease in HCW who had disease
Time Frame
90 days
Title
Number or respiratory failure attributable to COVID-19 disease
Description
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
Time Frame
90 days
Title
Mortality Incidence
Description
Cumulative Incidence of Mortality attributed to COVID-19 disease in HCW who developed disease
Time Frame
90 days
Title
Days of work lost
Description
Number of days unable to work attributed to COVID-19 in HCW who developed disease
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Proportion of HCW with plasma able to neutralize SARS-CoV-2 virus
Description
Proportion of participants with plasma able to neutralize SARS-CoV-2 virus (plaque reduction neutralization test) in vitro.
Time Frame
90 days
Title
Number of participants with severity markers of host immune and endothelial activation
Description
Number of participants with severity markers of host immune and endothelial activation measured at clinical presentation and their ability to predict severity and outcome.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Age ≥18 years.
Ability to communicate with study staff in English
Exclusion Criteria:
Known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds.
Current use of hydroxychloroquine for the treatment of a medical condition.
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.
Known pre-existing retinopathy of the eye.
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).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bradley A Connor, MD
Phone
9172138998
Email
bconnor1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Rogova, RN
Phone
8434247542
Email
marina.rogova@connormd.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley A Connor, MD
Organizational Affiliation
Dr. Bradley A. Connor
Official's Role
Principal Investigator
Facility Information:
Facility Name
The New York Center for Travel and Tropical Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley A Connor, MD
Phone
212-988-2800
Email
bconnor1@gmail.com
First Name & Middle Initial & Last Name & Degree
Marina Rogova, RN
Phone
8434247542
Email
marina.rogova@connormd.com
First Name & Middle Initial & Last Name & Degree
William MacLeod, ScD
First Name & Middle Initial & Last Name & Degree
Robert S Brown, Jr, MD
First Name & Middle Initial & Last Name & Degree
Kevin Kain, MD
First Name & Middle Initial & Last Name & Degree
Megan Landes, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
supporting made available to other researchers
IPD Sharing Time Frame
From July 1, 2020 until December 31, 2020
IPD Sharing Access Criteria
from our web site
IPD Sharing URL
http://www.geosentinel.com
Links:
URL
https://www.nih.gov/coronavirus
Description
coronavirus references
Learn more about this trial
HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial
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