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Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429867
Recruitment Status : Active, not recruiting
First Posted : June 12, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
WellStar Health System

Brief Summary:
The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Placebo Phase 4

Detailed Description:
This study will utilize a randomized, placebo-controlled, double-blinded design. Patients admitted with confirmed COVID-19, and at least 1 of the following: requiring oxygen supplementation (≤4 liters of oxygen via nasal cannula or increase from baseline), bilateral infiltrates on CT/CXR, age >65, diabetes, hypertension, BMI > 35, chronic lung disease, cardiovascular disease, chronic kidney disease, cancer (hematologic malignancies, lung cancer, and metastatic disease), will be randomized in a 1:1 fashion to hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses or placebo at a matching schedule.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
Actual Study Start Date : May 7, 2020
Estimated Primary Completion Date : December 7, 2020
Estimated Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine Drug: Hydroxychloroquine
Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses

Placebo Comparator: Placebo Drug: Placebo
Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses




Primary Outcome Measures :
  1. Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease. [ Time Frame: 30 Days ]
    The impact will be evaluated by comparing rates of a composite primary outcome in patients randomized to hydroxychloroquine versus those randomized to placebo. The composite outcome includes progression to severe/critical disease or death (including withdrawal of care/hospice transfer). Progression to severe/critical disease is defined by requiring oxygen delivery via high flow nasal cannula, non-rebreather mask, bipap, or transfer to intensive care (ICU) or intermediate care units (IMCU) due to COVID-19-related complications.


Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: 30 Days ]
  2. 30-Day Mortality [ Time Frame: 30 Days ]
  3. Resolution of Symptoms [ Time Frame: 14 Days ]
    Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.

  4. Incidence of QTc >500ms after initiation of therapy [ Time Frame: 30 Days ]
  5. Incidence of discontinuation of therapy [ Time Frame: 30 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to Wellstar Kennestone Hospital
  • Age 18 years or older
  • Laboratory-confirmed COVID-19
  • At least 1 of the following:

    1. Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from baseline
    2. Bilateral infiltrates on CXR or CT of chest
    3. Age 65 or older
    4. Diabetes
    5. Hypertension
    6. BMI > 35
    7. Chronic lung disease
    8. Cardiovascular disease
    9. Chronic kidney disease
    10. Cancer (hematologic malignancies, lung cancer, and metastatic disease)

Exclusion Criteria:

  • Unable to provide informed consent
  • Unable to take oral medication
  • Severe/critical COVID-19 disease at presentation

    1. Intensive care or intermediate care required at admission or within 48 hours
    2. Requiring oxygen supplementation via high flow nasal cannula, bipap, or non-rebreather mask at admission or within 48 hours
  • Likelihood of survival <48 hours in the opinion of the primary physician or transitioned to comfort measures within 48 hours of admission
  • Inability to take hydroxychloroquine due to allergy, QTc > 500 ms (male) or 520 ms (female) prior to initiation of hydroxychloroquine, pre-existing retinopathy, known G6PD deficiency, known porphyria, or significant drug- drug interactions
  • Pregnant or breastfeeding
  • Severe liver disease (Child-Pugh Class C)

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): NCT04429867


Locations
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United States, Georgia
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Sponsors and Collaborators
WellStar Health System
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Responsible Party: WellStar Health System
ClinicalTrials.gov Identifier: NCT04429867    
Other Study ID Numbers: 1604885
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 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.: No
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents