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

NCT04345692 | Terminated Phase 3 FDA Drug

• 1 other identifier: RA-2020-018
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• i. Clinical status

  Clinical Status (on a 7-point ordinal scale) at day 15 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

  Clinical Status (on a 7-point ordinal scale) at day 15

Secondary Outcomes (4)

• Oxygenation

  up to day 28

• Mechanical Ventilation

  up to day 28

• Hospitalization

  up to day 28

• Mortality

  up to day 28

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

Hydroxychloroquine 400 mg 2x day by mouth on day 1, followed by 200 mg 2x day by mouth days 2-5

Drug: Hydroxychloroquine

Usual Care

NO INTERVENTION

usual care for hospitalized patients diagnosed with COVID-19

Interventions

Hydroxychloroquine DRUG

oral tablet administered by hospital staff or if discharged before day 5 - self administered oral tablet

Also known as: Plaquenil

Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Queen's Medical Center: lead

Study Sites (1)

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Todd Seto, MD

  Queen's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, 2 arm, open label hydroxychloroquine plus usual care compared to usual care in hospitalized patients

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: March 26, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)