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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04429867
• Other study ID #: 1604885
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 7, 2020
• Est. completion date: December 7, 2020

Study information

• Verified date: June 2020
• Source: WellStar Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Disease Progression

Intervention

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

Locations

Country	Name	City	State
United States	Wellstar Kennestone Hospital	Marietta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
WellStar Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.	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.	30 Days
Secondary	Hospital length of stay		30 Days
Secondary	30-Day Mortality		30 Days
Secondary	Resolution of Symptoms	Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.	14 Days
Secondary	Incidence of QTc >500ms after initiation of therapy		30 Days
Secondary	Incidence of discontinuation of therapy		30 Days