Anti-inflammatory Clarithromycin for Improving COVID-19 Infection Early

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Recent information appearing from different countries suggest that treatment of Coronavirus disease 2019 (COVID-19) with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin to treatment regimen of COVID-19 is associated with early clinical improvement and attenuation of the high inflammatory burden of the host. The study will not comprise a placebo-comparator group since this is considered inappropriate in an era of a pandemic with substantial global mortality.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Institute for the Study of Sepsis
• Treatments: Clarithromycin

Criteria

Inclusion Criteria:

• Age ≥18 years

• Male of female gender

• Written informed consent provided by the patients or by a first-degree relative in case of patients unable to consent

• In case of women, unwillingness to remain pregnant during the study period achieved either by their partner using condom or by themselves using oral contraceptives.

• Confirmed infection by SARS-CoV-2 virus

• Infection of the upper respiratory tract or of the lower respiratory tract

Exclusion Criteria:

• Age below 18 years

• Denial of written informed consent

• Intake of any macrolide for the current episode of infection under study

• Intake of hydroxychloroquine or chloroquine phosphate.

• Presence of severe respiratory failure

• Oral or intravenous intake of corticosteroids defined as any more than 0.4mg/kg daily intake of equivalent prednisone for the last 15 days

• Neutropenia defined as an absolute neutrophil count below 1,000/mm3

• Presence of any contraindications for the study drugs as stated in local label information

• QTc interval at rest electrocardiogram ≥500 msec or history of known congenital long QT syndrome

• Pregnancy or lactation