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

NCT04352946 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: GFICOVID-19-1
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

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).

Conditions

Prophylaxis; COVID-19; Health Care Worker; Hydroxychloroquine

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of COVID-19 Infection

  Incidence of symptomatic and asymptomatic COVID-19 infection in health care workers

  90 days

Secondary Outcomes (6)

• Adverse events incidence

  90 days

• Duration of symptomatic COVID-19 disease

  90 days

• Days hospitalized attributed to COVID-19

  90 days

• Number or respiratory failure attributable to COVID-19 disease

  90 days

• Mortality Incidence

  90 days

Other Outcomes (2)

• Proportion of HCW with plasma able to neutralize SARS-CoV-2 virus

  90 days

• Number of participants with severity markers of host immune and endothelial activation

  90 days

Study Arms (2)

Hydrocholoroquine Pre-exposure prophylaxis

EXPERIMENTAL

HCQ will be administered as 400mg orally once for 60 days.

Drug: Hydroxychloroquine Pre-Exposure Prophylaxis

Placebo

PLACEBO COMPARATOR

Placebo will be administered as 400mg orally once for 60 days.

Drug: Placebo oral tablet

Interventions

Hydroxychloroquine Pre-Exposure Prophylaxis DRUG

HCQ PreP 400mg daily

Also known as: Hydroxychloroquine PreP, HCQ PreP

Hydrocholoroquine Pre-exposure prophylaxis

Placebo oral tablet DRUG

Placebo tablets 400mg daily

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GeoSentinel Foundation: lead

Study Sites (1)

The New York Center for Travel and Tropical Medicine

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bradley A Connor, MD

  Dr. Bradley A. Connor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bradley A Connor, MD

CONTACT

9172138998; bconnor1@gmail.com

Marina Rogova, RN

CONTACT

8434247542; marina.rogova@connormd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine, Weill Cornell Medicine

Model Details: HCW are randomized to either the study drug (HCQ) or placebo.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: April 24, 2020
• Primary Completion: June 24, 2020
• Study Completion: August 24, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From July 1, 2020 until December 31, 2020
• Access Criteria: from our web site

Locations

US (1)