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

WellStar Health System

Status and phase: Unknown; Phase 4

Conditions: COVID-19

Treatments: Drug: Hydroxychloroquine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04429867

1604885

Details and patient eligibility

About

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

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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700 participants in 2 patient groups, including a placebo group

Hydroxychloroquine

Experimental group

Treatment:

Drug: Hydroxychloroquine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo