Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-Cov-2 Virus (COVID-19)

• Status: Active, not recruiting
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

Summary

Coronavirus (COVID-19) is a somewhat new and recognized infectious disease that is now spreading to several countries in the world, including Brazil. Hydroxychloroquine and azithromycin may be useful for treating those patients.

COALITION I study aims to compared standard of care, hydroxychloroquine plus azithromycin and hydroxychloroquine monotherapy for treatment of hospitalized patients with COVID-19.

COALITION I will recruit 630 patients with infection by COVID-19 (210 per arm). Ordinal endpoint of status at 15 days will be the primary endpoint.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital do Coracao
• Collaborators: Brazilian Research In Intensive Care Network; EMS; Hospital Israelita Albert Einstein; Hospital Sirio-Libanes
• Treatments: Azithromycin; Hydroxychloroquine

Criteria

Inclusion Criteria:

• Patients with suspected or confirmed COVID-19 admitted to inpatient units and intensive care units

Exclusion Criteria:

• Need for oxygen supplementation > 4 litters per min

• Patients using a high-flow nasal catheter

• Patients using non-invasive mechanical ventilation

• Patients using invasive mechanical ventilation

• Males and females aged < 18 years

• Pregnancy

• Allergy to chloroquine or derivatives

• Allergy to azithromycin

• Patients that have already received more than one dose of either azithromycin or hydroxychloroquine before enrollment

• Patients with respiratory symptoms for more than 14 days