CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Hydroxychloroquine Sulfate (HCQ)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04345653
NCT04345653Phase 2Completed

Feasibility, Safety and Early Efficacy Trial of Hydroxychloroquine as Primary Prevention of Corona Virus Disease 2019 in High Risk Health Care Providers

Hackensack Meridian Health·interventional·Posted Apr 14, 2020·Updated May 12, 2021

In Brief

A Phase 2 clinical trial evaluating Hydroxychloroquine Sulfate (HCQ) for Covid19. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The study proposes to conduct an open-label Phase II trial to evaluate the feasibility, safety and early efficacy of hydroxychloroquine (HCQ) administration in reduction of transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and development of Corona Virus Disease 2019 (COVID-19) in high-risk, healthy acute care provider participants exposed, directly or indirectly, to COVID-19 patients. There is a more than 50 years track record of safety of HCQ for treatment and prevention of various disease states. Early data on use of HCQ for COVID treatment suggests anti-viral activity and immunomodulatory properties for reducing inflammation associated with COVID-19.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 14, 2020
Enrollment StartApr 14, 2020
Primary CompletionJun 5, 2020
Study CompletionMay 10, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.2 years ago

Interventions

Hydroxychloroquine Sulfate (HCQ)drug

Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.