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

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ClinicalTrials.gov Identifier: NCT04345692
Recruitment Status : Terminated (RECOVERY Trial results - no efficacy)
First Posted : April 14, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Queen's Medical Centre

Tracking Information
First Submitted Date  ICMJE April 9, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE March 26, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
  • 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
  • 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
  • Hospitalization [ Time Frame: up to day 28 ]
    Duration of hospitalization (days)
  • Mortality [ Time Frame: up to day 28 ]
    28-day mortality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
Official Title  ICMJE A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: Hydroxychloroquine
oral tablet administered by hospital staff or if discharged before day 5 - self administered oral tablet
Other Name: Plaquenil
Study Arms  ICMJE
  • Experimental: Hydroxychloroquine
    Hydroxychloroquine 400 mg 2x day by mouth on day 1, followed by 200 mg 2x day by mouth days 2-5
    Intervention: Drug: Hydroxychloroquine
  • No Intervention: Usual Care
    usual care for hospitalized patients diagnosed with COVID-19
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 13, 2020)
17
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2020)
350
Actual Study Completion Date  ICMJE August 31, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04345692
Other Study ID Numbers  ICMJE RA-2020-018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Queen's Medical Centre
Study Sponsor  ICMJE Queen's Medical Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Todd Seto, MD Queen's Medical Centre
PRS Account Queen's Medical Centre
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP