Status:
TERMINATED
A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
Lead Sponsor:
Queen's Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
18-95 years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
The overall objective is to evaluate the clinical efficacy and safety of hydroxychloroquine (HCQ) relative to standard of care among 350 hospitalized adult patients who have COVID-19. Primary Aim i. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04345692
Start Date
March 26 2020
End Date
August 31 2020
Last Update
November 17 2020
Active Locations (1)
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1
Queen's Medical Center
Honolulu, Hawaii, United States, 96813