A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients (OAHU-COVID19)

A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: Hydroxychloroquine

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Queen's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydroxychloroquine; Hydroxychloroquine 400 mg 2x day by mouth on day 1, followed by 200 mg 2x day by mouth days 2-5	Drug: Hydroxychloroquine; oral tablet administered by hospital staff or if discharged before day 5 - self administered oral tablet; Other Names: Plaquenil
No Intervention: Usual Care; usual care for hospitalized patients diagnosed with COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
i. Clinical status	Clinical Status (on a 7-point ordinal scale) at day 15; Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death	Clinical Status (on a 7-point ordinal scale) at day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation	Oxygenation free days in the first 28 days Incidence and duration of new oxygen use during the study	up to day 28
Mechanical Ventilation	Ventilator free days in the first 28 days Incidence and duration of new mechanical ventilation use during hospitalization	up to day 28
Hospitalization	Duration of hospitalization (days)	up to day 28
Mortality	28-day mortality	up to day 28

Collaborators and Investigators

• Sponsor: Queen's Medical Center
• Investigators: Principal Investigator: Todd Seto, MD, Queen's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines; Aminoquinolines; Chloroquine; Hydroxychloroquine
• Other Study ID Numbers: RA-2020-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes