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

Phase 4

• Conditions: COVID-19
• Interventions: Drug: Placebo; Drug: Hydroxychloroquine

• Registration Number: NCT04429867
• Lead Sponsor: WellStar Health System

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.

Study Timeline

• Study Start: 2020-05-07
• Status Verified: 2020-06
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-11
• Last Update Submitted: 2020-06-11
• Study First Posted: 2020-06-12
• Last Update Posted: 2020-06-16
• Primary Completion: 2020-12-07
• Study Completion: 2020-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Hydroxychloroquine	Hydroxychloroquine	-

Primary Outcome Measures

Name	Time	Method
Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.	30 Days	The impact will be evaluated by comparing rates of a composite primary outcome in patients randomized to hydroxychloroquine versus those randomized to placebo. The composite outcome includes progression to severe/critical disease or death (including withdrawal of care/hospice transfer). Progression to severe/critical disease is defined by requiring oxygen delivery via high flow nasal cannula, non-rebreather mask, bipap, or transfer to intensive care (ICU) or intermediate care units (IMCU) due to COVID-19-related complications.

Secondary Outcome Measures

Name	Time	Method
Resolution of Symptoms	14 Days	Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.
30-Day Mortality	30 Days
Incidence of QTc >500ms after initiation of therapy	30 Days
Hospital length of stay	30 Days
Incidence of discontinuation of therapy	30 Days

Trial Locations

Locations (1)

Wellstar Kennestone Hospital; 🇺🇸 Marietta, Georgia, United States