CAM (Clarithromycin) Effectivity for COVID-19 pneumonia which does not require oxygen administration; multicenter, randomized-controlled, open-label, 3-armed parallel group comparison, exploratory trial

Not Applicable

• Conditions: COVID-19 pneumonia which does not require oxygen administration; COVID-19, Clarith, Clarithromycin, Macrolide antimicrobial agents

• Registration Number: JPRN-jRCTs071210011
• Lead Sponsor: Mukae Hiroshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients who meet all of the following criteria are included in this study:
1. Patients who were detected SARS-CoV-2 in PCR tests or LAMP method within 3 days before the informed consent.
2. Patients with pneumonia image by routine chest radiography or chest CT.
3. Japanese patients who are aged of 20 years or older.
4. Patients who give their written consent form to participate in the study.

Exclusion Criteria

Patients who fall into any of the following criteria are excluded from participating in the study:
1. Patients who has the symptom 8 days or longer.
2. Patients who are treated by macrolide antimicrobial agents.
3. Patients who are treated by steroids (except inhalants) or immunosuppressive agents
4. Patients who are diagnosed with influenza.
5. Patients whose SPO2 is less than or equal to 93%. (at room)
6. Patients with hepatic dysfunction. (AST / ALT more than 5 times of the facility standard value or Child-Pugh B/C)
7. Patients with renal dysfunction. (Cre more than twice of the facility standard value and eGFR<30ml/min)
8. Patients whose peripheral blood neutrophils are less than 1,000/uL.
9. Patients who have history of hypersensitivity to macrolide antimicrobial agents.
10. Patients who are pregnant, breastfeeding.
11. Patients who have been vaccinated against COVID-19 in the past.
12. Patients with other conditions that the investigator thinks inappropriate to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified