Efficacy of clarithromycin in patients with mild COVID-19 pneumonia not receiving oxygen administration: protocol for an exploratory, multicentre, open-label, randomised controlled trial (CAME COVID-19 study)
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Abstract
The COVID-19 pandemic has emerged worldwide. Although several medications have been approved for treating moderate-to-severe COVID-19, very few treatment strategy has been established for patients with mild COVID-19 who do not require oxygen administration. Clarithromycin is a macrolide antimicrobial agent that has been widely used for bacterial respiratory infectious diseases. Clarithromycin also acts an immunomodulating drug and suppresses cytokine storms in viral respiratory diseases, including influenza. In this study, we aim to evaluate the efficacy of clarithromycin in patients with mild COVID-19.
Methods and analysis
This is an exploratory, multicentre, open-label, randomised controlled trial. This study was initiated in May 2021 and will end in July 2022. Patients with mild COVID-19 pneumonia who do not require oxygen administration will be enrolled and randomly assigned in a 1:1:1 ratio to group A (administration of clarithromycin 800 mg/day), group B (administration of clarithromycin 400 mg/day) or group C (standard treatment without clarithromycin). The planned number of enrolled patients is 60 (20 patients × three groups). The primary endpoint is the number of days required to improve the clinical symptoms as measured by the severity score. Secondary endpoints include days for recovery of the body temperature, proportion of patients with oxygen administration, inflammatory cytokines, viral load, serum immunoglobulins, peripheral blood lymphocytes, blood biomarkers and pneumonia infiltrations.
Ethics and dissemination
The study protocol was approved by the Clinical Research Review Board of Nagasaki University in accordance with the Clinical Trials Act in Japan. The study will be conducted in accordance with the Declaration of Helsinki, the Clinical Trials Act and other current legal regulations in Japan. Written informed consent will be obtained from all the participants. The results of this study will be reported as journal publications.
Trial registration number
jRCTs071210011.
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SciScore for 10.1101/2021.06.02.21258257: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Study design and setting: “The 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” (CAME COVID study) was initiated in May 2021, after the approval by the Clinical Research Review Board in Nagasaki University in March, 2021 and the registration/publication at the Japan Registry of Clinical Trials (jRCT) (registration number: jRCTs071210011) in April, 2021.
Consent: As shown in Figure 1, subjects who are eligible for this study will be asked to participate in this study, and informed consent will be obtained prior to the …SciScore for 10.1101/2021.06.02.21258257: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Study design and setting: “The 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” (CAME COVID study) was initiated in May 2021, after the approval by the Clinical Research Review Board in Nagasaki University in March, 2021 and the registration/publication at the Japan Registry of Clinical Trials (jRCT) (registration number: jRCTs071210011) in April, 2021.
Consent: As shown in Figure 1, subjects who are eligible for this study will be asked to participate in this study, and informed consent will be obtained prior to the registration/randomization.Sex as a biological variable (creatinine is more than twice the upper limit of normal in each medical institution, and estimated glomerular filtration rate is less than 30 ml/min/1.73 m2); 8) patients whose peripheral blood neutrophils are less than 1,000/µL; 9) patients who have a history of hypersensitivity to macrolide antimicrobial agents; 10) patients who are pregnant or breastfeeding; 11) patients who have a history of vaccination against COVID-19; and 12) patients with other conditions that the investigator thinks may render them inappropriate to participate in the study. Randomization Study design and setting: “The 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” (CAME COVID study) was initiated in May 2021, after the approval by the Clinical Research Review Board in Nagasaki University in March, 2021 and the registration/publication at the Japan Registry of Clinical Trials (jRCT) (registration number: jRCTs071210011) in April, 2021. Blinding not detected. Power Analysis Sample size calculation: Since no clinical trial has evaluated the effect of clarithromycin on COVID-19 pneumonia, no reference data are available for the statistical sample size calculation in this study. Cell Line Authentication Authentication: Table 1 shows the schedule of assessments performed at each observation point, including the mandatory and optional assessments. 2) Inspection of subjects’ characteristics (height, weight, body mass index, onset of COVID-19, detection date of SARS-CoV-2, date of hospitalization, anamnesis and comorbidity); 4) vital signs (body temperature, systolic blood pressure, diastolic blood pressure, pulse, percutaneous oxygen saturation, and frequency of breath); 7) hematology tests (red blood cell, hemoglobin, hematocrit, white blood cell, neutrophil, lymphocyte, eosinophil, monocyte, basophil, and platelet); 8) general blood biochemical tests (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-guanosine triphosphate, total cholesterol, total protein, albumin, blood urea nitrogen, creatinine-estimated glomerular filtration rate based on creatinine, lactate dehydrogenase, creatine phosphokinase, brain natriuretic peptide, troponin T, C-reactive protein, procalcitonin, ferritin, Na, pH, and hemoglobin A1c); 9) blood coagulation tests (prothrombin time, activated partial thromboplastin time, and d-dimer); 10) chest radiography and computerized tomography; and 14) inspection of medications of other pharmaceutical agents are conducted by general inspection and interview. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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