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

COVID-19 Clinical Trial

— HERO  

Official title:

Protecting Health Care Workers From COVID-19 With Hydroxychloroquine Pre-exposure Prophylaxis: A Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04352946
• Other study ID #: GFICOVID-19-1
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 24, 2020
• Est. completion date: August 24, 2020

Study information

• Verified date: April 2020
• Source: GeoSentinel Foundation
• Contact: Bradley A Connor, MD
• Phone: 9172138998
• Email: bconnor1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 374
• Est. completion date: August 24, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Health Care Worker
• Hydroxychloroquine
• Prophylaxis

Intervention

Drug:
• Hydroxychloroquine Pre-Exposure Prophylaxis
HCQ PreP 400mg daily
• Placebo oral tablet
Placebo tablets 400mg daily

Locations

Country	Name	City	State
United States	The New York Center for Travel and Tropical Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
GeoSentinel Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of HCW with plasma able to neutralize SARS-CoV-2 virus	Proportion of participants with plasma able to neutralize SARS-CoV-2 virus (plaque reduction neutralization test) in vitro.	90 days
Other	Number of participants with severity markers of host immune and endothelial activation	Number of participants with severity markers of host immune and endothelial activation measured at clinical presentation and their ability to predict severity and outcome.	90 days
Primary	Cumulative Incidence of COVID-19 Infection	Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers	90 days
Secondary	Adverse events incidence	Incidence of reported and grade of adverse events	90 days
Secondary	Duration of symptomatic COVID-19 disease	Duration in days of symptomatic COVID-19 disease in HCW who had disease	90 days
Secondary	Days hospitalized attributed to COVID-19	Duration in days of hospitalization attributed to COVID-19 disease in HCW who had disease	90 days
Secondary	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	90 days
Secondary	Mortality Incidence	Cumulative Incidence of Mortality attributed to COVID-19 disease in HCW who developed disease	90 days
Secondary	Days of work lost	Number of days unable to work attributed to COVID-19 in HCW who developed disease	90 days

External Links

•   coronavirus references