HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial (HERO)
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|ClinicalTrials.gov Identifier: NCT04352946|
Recruitment Status : Not yet recruiting
First Posted : April 20, 2020
Last Update Posted : April 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prophylaxis COVID-19 Health Care Worker Hydroxychloroquine||Drug: Hydroxychloroquine Pre-Exposure Prophylaxis Drug: Placebo oral tablet||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||374 participants|
|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.|
|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|
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
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
- Cumulative Incidence of COVID-19 Infection [ Time Frame: 90 days ]Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers
- Adverse events incidence [ Time Frame: 90 days ]Incidence of reported and grade of adverse events
- Duration of symptomatic COVID-19 disease [ Time Frame: 90 days ]Duration in days of symptomatic COVID-19 disease in HCW who had disease
- 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
- 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
- Mortality Incidence [ Time Frame: 90 days ]Cumulative Incidence of Mortality attributed to COVID-19 disease in HCW who developed disease
- Days of work lost [ Time Frame: 90 days ]Number of days unable to work attributed to COVID-19 in HCW who developed disease
- 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.
- 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.
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
|Contact: Bradley A Connor, MDemail@example.com|
|Contact: Marina Rogova, RNfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Marina Rogova, RN 8434247542 firstname.lastname@example.org|
|Sub-Investigator: William MacLeod, ScD|
|Sub-Investigator: Robert S Brown, Jr, MD|
|Sub-Investigator: Kevin Kain, MD|
|Sub-Investigator: Megan Landes, MD|
|Principal Investigator:||Bradley A Connor, MD||Dr. Bradley A. Connor|