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

NCT04429867 | Unknown Phase 4 FDA Drug

• 1 other identifier: 1604885
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hospital length of stay

  30 Days

• 30-Day Mortality

  30 Days

• Resolution of Symptoms

  14 Days

• Incidence of QTc >500ms after initiation of therapy

  30 Days

• Incidence of discontinuation of therapy

  30 Days

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses

Hydroxychloroquine

Placebo DRUG

Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to Wellstar Kennestone Hospital
• Age 18 years or older
• Laboratory-confirmed COVID-19
• At least 1 of the following:
• Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from baseline
• Bilateral infiltrates on CXR or CT of chest
• Age 65 or older
• Diabetes
• Hypertension
• BMI \> 35
• Chronic lung disease
• Cardiovascular disease
• Chronic kidney disease
• Cancer (hematologic malignancies, lung cancer, and metastatic disease)

You may not qualify if:

• Unable to provide informed consent
• Unable to take oral medication
• Severe/critical COVID-19 disease at presentation
• Intensive care or intermediate care required at admission or within 48 hours
• 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)

Sponsors & Collaborators

• WellStar Health System: lead

Study Sites (1)

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: May 7, 2020
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)