Clinical trial NCT04345692: A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
Official title: A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Queen's Medical Center
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, 2 arm, open label hydroxychloroquine plus usual care compared to usual care in hospitalized patients
Primary purpose: TREATMENT

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 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.

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: i. Clinical status
timeFrame: Clinical Status (on a 7-point ordinal scale) at day 15
Secondary outcomes:
measure: Oxygenation
timeFrame: up to day 28
measure: Mechanical Ventilation
timeFrame: up to day 28
measure: Hospitalization
timeFrame: up to day 28
measure: Mortality
timeFrame: up to day 28
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
Study officials:
affiliation: Queen's Medical Center
name: Todd Seto, MD
role: PRINCIPAL_INVESTIGATOR
References: