Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ)
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|ClinicalTrials.gov Identifier: NCT04334148|
Recruitment Status : Completed
First Posted : April 6, 2020
Results First Posted : October 7, 2021
Last Update Posted : October 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Hydroxychloroquine Drug: Placebo oral tablet||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1360 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind, placebo-controlled, randomized clinical trial.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)|
|Actual Study Start Date :||April 22, 2020|
|Actual Primary Completion Date :||December 10, 2020|
|Actual Study Completion Date :||January 9, 2021|
Active Comparator: Hydroxychloroquine
Hydroxychloroquine tablet 600mg bid loading dose on day 1 followed by 400mg on days 2-30.
oral self administered tablet
Other Name: Plaquenil
Placebo Comparator: Placebo
Matching placebo tablets
Drug: Placebo oral tablet
oral self administered tablet
- Number of Participants With Clinical Infection With COVID-19 Infection [ Time Frame: 30 days ]This measure was a combination of confirmed infection and suspected infection. Confirmed clinical infection was defined as new-onset of fever or cough or dyspnea AND confirmed COVID-19 positive test result via local PCRI testing. Suspected infection was defined as new-onset fever or cough or dyspnea without local PCR testing due to local restrictions and/or testing policies.
- Number of Participants With COVID-19 Viral Shedding [ Time Frame: 30 days ]Number of participants with COVID-19 infection shedding via Covance swab PCR testing
- Number of Participants With Serious Adverse Events (SAEs) or Hydroxychloroquine-Associated Events of Special Interest (EOSIs) [ Time Frame: 30 days ]Safety and Tolerability as determined by subject reported serious adverse events (SAEs) and hydroxychloroquine-associated events of special interest. EOSIs include: arrhythmias (ventricular), hepatic failure, bone marrow failure, aplastic anemia, prolonged QT interval, angioedema, dermatitis exfoliative, acute generalized exanthematous pustulosis, psychosis, suicidal ideation, seizure, methemoglobinemia.
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): NCT04334148
|Principal Investigator:||Adrian Hernandez, MD||Duke University|