Back to resultsHydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Admitted to Wellstar Kennestone Hospital
- Age 18 years or older
- Laboratory-confirmed COVID-19
At least 1 of the following:
- Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from baseline
- Bilateral infiltrates on CXR or CT of chest
- Age 65 or older
- Diabetes
- Hypertension
- BMI > 35
- Chronic lung disease
- Cardiovascular disease
- Chronic kidney disease
- 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
- Intensive care or intermediate care required at admission or within 48 hours
- 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)
Sites / Locations
- Wellstar Kennestone Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydroxychloroquine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
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
Hospital length of stay
30-Day Mortality
Resolution of Symptoms
Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.
Incidence of QTc >500ms after initiation of therapy
Incidence of discontinuation of therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04429867
Brief Title
Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
Official Title
Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2020 (Actual)
Primary Completion Date
December 7, 2020 (Anticipated)
Study Completion Date
December 7, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
WellStar Health System
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
Primary Outcome Measure Information:
Title
Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
Description
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.
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Hospital length of stay
Time Frame
30 Days
Title
30-Day Mortality
Time Frame
30 Days
Title
Resolution of Symptoms
Description
Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.
Time Frame
14 Days
Title
Incidence of QTc >500ms after initiation of therapy
Time Frame
30 Days
Title
Incidence of discontinuation of therapy
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admitted to Wellstar Kennestone Hospital
Age 18 years or older
Laboratory-confirmed COVID-19
At least 1 of the following:
Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from baseline
Bilateral infiltrates on CXR or CT of chest
Age 65 or older
Diabetes
Hypertension
BMI > 35
Chronic lung disease
Cardiovascular disease
Chronic kidney disease
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
Intensive care or intermediate care required at admission or within 48 hours
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)
Facility Information:
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
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