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

• ClinicalTrials.gov Identifier: NCT04429867
• Recruitment Status: Unknown
• First Posted: June 12, 2020
• Last Update Posted: June 16, 2020
• Sponsor: WellStar Health System
• Information provided by (Responsible Party): WellStar Health System

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: Hydroxychloroquine; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 700 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
• Actual Study Start Date: May 7, 2020
• Estimated Primary Completion Date: December 7, 2020
• Estimated Study Completion Date: December 7, 2020

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease. [ Time Frame: 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 :

1. Hospital length of stay [ Time Frame: 30 Days ]
2. 30-Day Mortality [ Time Frame: 30 Days ]
3. Resolution of Symptoms [ Time Frame: 14 Days ]
   Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.
4. Incidence of QTc >500ms after initiation of therapy [ Time Frame: 30 Days ]
5. Incidence of discontinuation of therapy [ Time Frame: 30 Days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, Georgia

Wellstar Kennestone Hospital

Marietta, Georgia, United States, 30060

Sponsors and Collaborators

WellStar Health System

More Information

• Responsible Party: WellStar Health System
• ClinicalTrials.gov Identifier: NCT04429867
• Other Study ID Numbers: 1604885
• First Posted: June 12, 2020
• Last Update Posted: June 16, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

COVID-19; Coronavirus Infections; Coronaviridae Infections; Hydroxychloroquine; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents