CLARITHROMYCIN IN COVID-19

Phase 1

• Conditions: Management of infection by SARS-CoV-2 (COVID-19); MedDRA version: 20.0Level: LLTClassification code 10035738Term: Pneumonia viral NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001882-36-GR
• Lead Sponsor: Hellenic Institute for the Study of Sepsis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-30
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

• Age below 18 years
• Denial of written informed consent
• Presence of severe respiratory failure
• Intake of any macrolide for the current episode of infection under study
• Intake of hydroxychloroquine or chloroquine phosphate.
• Oral or intravenous intake of corticosteroids defined as any more than 0.4mg/kg daily intake of equivalent prednisone for the last 3 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 ECG =500 msec or history of known congenital long QT syndrome
• Pregnancy or lactation

Study & Design

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