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The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | 30 Days | |
| 30-Day Mortality | 30 Days | |
| Resolution of Symptoms |
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Inclusion Criteria:
Admitted to Wellstar Kennestone Hospital
Age 18 years or older
Laboratory-confirmed COVID-19
At least 1 of the following:
Exclusion Criteria:
Unable to provide informed consent
Unable to take oral medication
Severe/critical COVID-19 disease at presentation
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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Placebo | Drug | Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses |
|
Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.
| 14 Days |
| Incidence of QTc >500ms after initiation of therapy | 30 Days |
| Incidence of discontinuation of therapy | 30 Days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |