A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients

Stopped early · Phase 3

Conditions studied: COVID-19

In brief

This study is a randomized, open label clinical trial to evaluate the safety and efficacy of hydroxychloroquine (HCQ) plus usual care compared to usual care in approximately 350 hospitalized patients diagnosed with COVID-19. The study will be a 2-arm, non-blinded comparison between open label hydroxychloroquine and usual care. The course of treatment (HCQ) is five days. Participants will be followed to study day 28.

Key facts

Study ID

NCT04345692

Run by

Queen's Medical Center

People needed

17

Starts

2020-03-26

Expected to finish

2020-08-31

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• i. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
• ii. Understands and agrees to comply with planned study procedures. iii. Male or female adult ≥18 - 95 years of age at time of enrolment. iv. Laboratory-confirmed SARS-CoV-2 infection in any specimen < 5 days prior to randomization.
• v. At least one of the following:
• Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) or
• Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤94% on room air vi. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.

You may not qualify if…

• i. History of liver failure ii. History of stage 4 severe chronic kidney disease or requiring dialysis iii. Self-reported pregnant or breast feeding. iv. Allergy to hydroxychloroquine or choloroquine v. Known contraindication to hydroxychloroquine, including retinopathy, G6PD deficiency, QT prolongation

Where it is running

• Queen's Medical Center — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

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