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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345692
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Queen's Medical Centre

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, 2 arm, open label hydroxychloroquine plus usual care compared to usual care in hospitalized patients
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
Actual Study Start Date : March 26, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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 Name: Plaquenil

No Intervention: Usual Care
usual care for hospitalized patients diagnosed with COVID-19



Primary Outcome Measures :
  1. i. Clinical status [ Time Frame: Clinical Status (on a 7-point ordinal scale) at day 15 ]

    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


Secondary Outcome Measures :
  1. Oxygenation [ Time Frame: up to day 28 ]
    Oxygenation free days in the first 28 days Incidence and duration of new oxygen use during the study

  2. Mechanical Ventilation [ Time Frame: up to day 28 ]
    Ventilator free days in the first 28 days Incidence and duration of new mechanical ventilation use during hospitalization

  3. Hospitalization [ Time Frame: up to day 28 ]
    Duration of hospitalization (days)

  4. Mortality [ Time Frame: up to day 28 ]
    28-day mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345692


Contacts
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Contact: Todd Seto, MD 808 354-3533 tseto@queens.org
Contact: May Vawer, RN 808 691-7185 mvawer@queens.org

Locations
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United States, Hawaii
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Todd Seto, MD    808-354-3533    tseto@queens.org   
Contact: May Vawer, RN    808 691-7185    mvawer@queens.org   
Sponsors and Collaborators
Queen's Medical Centre
Investigators
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Principal Investigator: Todd Seto, MD Queen's Medical Centre
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Responsible Party: Queen's Medical Centre
ClinicalTrials.gov Identifier: NCT04345692    
Other Study ID Numbers: RA-2020-018
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents