NCT04334148

Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine

Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,360 (actual)
• Sponsor: Adrian Hernandez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. Course of treatment is 30 days.

Detailed description

This is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to COVID-19. Eligible participants will be randomly assigned (1:1) to either treatment group (HCQ) or placebo in a double-blind fashion. After enrollment, baseline assessments will include nasopharyngeal swab for COVID-19 and a blood sample to detect seroconversion to COVID-19. For convenience, follow-up will be performed weekly through a direct to participant portal. A call center will provide support for any missed visits. Follow-up includes screening for any COVID-19 clinical infections, other respiratory infections, clinical events, adverse events, and Quality of Life (QoL) assessments. Course of treatment is 30 days. Participants are followed via survey weekly. At the end of treatment participants will return for repeat nasopharyngeal swab for COVID-19 and a blood sample to detect seroconversion to COVID-19. There will be one last contact at 8 weeks (2 months) from baseline.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	oral self administered tablet
DRUG	Placebo oral tablet	oral self administered tablet

Timeline

• Start date: 2020-04-22
• Primary completion: 2020-12-10
• Completion: 2021-01-09
• First posted: 2020-04-06
• Last updated: 2021-10-12
• Results posted: 2021-10-07

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated drug study