Clinical trial NCT04429867: Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
Official title: Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: WellStar Health System
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
timeFrame: 30 Days
Secondary outcomes:
measure: Hospital length of stay
timeFrame: 30 Days
measure: 30-Day Mortality
timeFrame: 30 Days
measure: Resolution of Symptoms
timeFrame: 14 Days
measure: Incidence of QTc >500ms after initiation of therapy
timeFrame: 30 Days
measure: Incidence of discontinuation of therapy
timeFrame: 30 Days
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Wellstar Kennestone Hospital
state: Georgia
Study officials:
References: