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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Hydroxychloroquine
  • Drug: Hydroxychloroquine
    Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
Placebo Comparator
Placebo
  • Drug: Placebo
    Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses

Recruiting Locations

More Details

NCT ID
NCT04429867
Status
Unknown status
Sponsor
WellStar Health System

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.