COVID-19: addition of azithromycin to chloroquine treatment

Phase 1

• Conditions: COVID-19; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001527-14-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-06
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Proven diagnosis of COVID-19 by positive PCR in any specimen < 48 hours prior to randomization.
•Age = 18 year
•Hospitalized patients with illness of any duration, and SpO2 = 94% on room air

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•Severe hypoxemic respiratory failure expected to die < 72 hours after admission
•ICU admission < 72 hours
•Allergy for chloroquine or azithromycin
•Pregnancy
•QT-prolongation: pre-existent: QTc males >450ms, QTc females > 470ms at day 1 and at day 2
•Myasthenia gravis
•Epilepsy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified