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

• Status: Active, not recruiting
• Trial end date: 2020-12-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: WellStar Health System
• Treatments: Hydroxychloroquine

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)