Status:
COMPLETED
Anti-inflammatory Clarithromycin for Improving COVID-19 Infection Early
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Conditions:
COVID-19
Virus Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Humanity is experiencing since December 2019 a new pandemic by the novel SARS Coronavirus-19 (SARS-CoV-2). As of March 25 2020 418,099 documented case were reported worldwide; 18,608 patients died. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04398004
Start Date
May 6 2020
End Date
November 30 2020
Last Update
January 11 2021
Active Locations (9)
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1
COVID-19 Department, General Hospital of Attica SISMANOGLEIO-AMALIA FLEMING
Marousi, Athens, Greece, 15126
2
2nd Department of Internal Medicine, General Hospital of Nikaia
Piraeus, Attica, Greece, 18454
3
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Alexandroupoli, Greece, 68100
4
1st University Department of Internal Medicine, LAIKO General Hospital of Athens
Athens, Greece, 11527