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

NCT ID: NCT04429867

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-07
• Study Completion Date: 2020-12-07

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hydroxychloroquine

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses

Interventions

Hydroxychloroquine

Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses

Intervention Type: DRUG

Placebo

Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

WellStar Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Countries

United States

Other Identifiers

1604885

Identifier Type: -

Identifier Source: org_study_id