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

JRCT ID: jRCTs071210011

Registered date:13/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19 pneumonia which does not require oxygen administration
• Date of first enrollment: 12/05/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

After obtaining consents, the subjects are randomly assigned to the following three groups at the time of allocation / registration.
A group : 800mg/day Clarithromycin administration group
B group : 400mg/day Clarithromycin administration group
C group : Control group (No medication or standard tratment of COVID-19)

Outcome(s)

• Primary Outcome: Days required to improve clinical symptoms by 50% or more from baseline (at registration)

Secondary Outcome

1. Days to recover the body temperature to below 37 degree after registration
2. Change in inflammatory cytokines in serum and nasal discharge from baseline
3. Proportion of subjects in whom all the clinical symptoms measured by the Severity Score are completely disappeared
4. Proportion of subjects in whom each clinical symptom measured by the Severity Score is improved 50% or more from baseline
5. Reduction rate of the SARS-CoV-2 virus from baseline
6. Change in serum IgG, IgM and IgA antibody from baseline
7. Recovery rate of peripheral blood lymphocyte
8. Proportion of subjects with oxygen administration who require follow-up
9. Other general blood markers and vital signs
10. Change in pneumonia image by chest radiography or chest CT

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Mukae Hiroshi
• Secondary Sponsor: Yamamoto Kazuko
• Source(s) of Monetary Support: Taisho Pharmaceutical Co., Ltd.