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.
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. Clinical status (on a 7-point ordinal scale) at day 15
Clinical Status 7-point ordinal scale:
1. Not hospitalized, no limitations on activities
2. Not hospitalized, limitation on activities
3. Hospitalized, not requiring supplemental oxygen
4. Hospitalized, requiring supplemental oxygen
5. Hospitalized, on non-invasive ventilation or high flow oxygen devices
6. Hospitalized, on invasive mechanical ventilation or ECMO
7. Death
After enrollment and randomization there will be baseline and then daily assessments of
clinical status and test results and procedures during hospitalization. Course of HCQ
treatment is 5 days. Participants are followed daily during hospitalization. All procedures,
evaluations and treatment, including the hydroxychloroquine laboratory tests, and radiology
tests are part of the usual clinical care for COVID-19 patients. This study will only collect
the information obtained as part of hospital standard of care. If the information is not
available, it will not be obtained by any other mechanism. After discharge there is a follow
up telephone call at day 15 and day 28. Follow-up assessment includes any clinical events,
adverse events, and clinic or emergency visits or hospitalizations. Participants in the HCQ
arm have safety labs: CBC and Comprehensive Metabolic profile scheduled on day 7 and 14.
Drug: Hydroxychloroquine
oral tablet administered by hospital staff or if discharged before day 5 - self administered oral tablet
Other Name: Plaquenil
Inclusion Criteria:
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:
1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) or
2. 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 Criteria:
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
Queen's Medical Center
Honolulu, Hawaii, United States
Todd Seto, MD, Principal Investigator
Queen's Medical Center