COVID-19
Conditions
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.
Interventions
DRUGHydroxychloroquine
Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
DRUGPlacebo
Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
Sponsors
WellStar Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease. | 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
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | 30 Days | — |
| 30-Day Mortality | 30 Days | — |
| Resolution of Symptoms | 14 Days | 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 | 30 Days | — |
| Incidence of discontinuation of therapy | 30 Days | — |
Countries
United States
Outcome results
None listed