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ウクライナにおける「MAF CAPSULES」を使用したCOVID-19臨床治験の最新情報(英文)

*現在、ウクライナにおいて新型コロナウィルス(COVID-19)入院患者へ「MAFシリーズ」の「MAF CAPSULES」を使用した臨床治験が行われており、初期報告内容は以下の通りです。英文となりますが、是非ご参照ください。

6-Jan-2021

Clinical trial using MAF for hospitalized COVID-19 patients in Ukraine

In June 2020 we applied to the COVID-19 Scientific Technical Triage of the US FDA for the evaluation of the rationale to study the efficacy of MAF Capsules in COVID-19 treatment. The US FDA in PreIND 151946 meeting response recommended a small proof of concept (POC) study as the initial step prior to the large-scale trial be run. The US FDA indicated recommendations including the major study endpoints addressing the investigation of MAF Capsules efficacy as a potential new drug was implemented in the proposed study design.
The recommended efficacy endpoints were also implemented in the open-label randomized clinical trial that started in Ukraine in November 2020 to assess the efficacy and safety of dietary supplements MAF Capsules, 148 mg and M Capsules, 148 mg in addition to standard of care (SOC) compared with SOC in the treatment of hospitalized non-critical COVID-19 patients.

Summary of preliminary results of clinical study
The ongoing interim study results showed a decrease in all-cause mortality and necessity of oxygen supply, as the mortality was 4/15 in the control group, vs 0/16 and 1/17 of currently enrolled patients in the MAF Capsules and M Capsules groups respectively. The mean duration of supplemental oxygen was 8.5 days in the control group, vs 4.1 and 5.1 days in the MAF Capsules and M Capsules groups respectively.
MAF Capsules, which is under investigational new drug process, is a dietary supplement that targets guts mucosal immunity to modulate macrophages functionality, limiting epithelial damage, and controlling inflammation response during COVID-19.

Clinical trial groups:
Control group
MAF Capsules (colostrum MAF) group
M Capsules (whey MAF) group

Patients randomized 1:1:1 to:
SOC (standard of care)
SOC plus MAF Capsules (148 mg, 3 caps. TID for 14 days)
SOC plus M Capsules (148 mg, 3 caps. TID for 14 days)

As compared to the control, both MAF groups showed a clear trend in decreasing mortality 
No adverse events
Decrease in the mortality rate
Decrease in necessity and duration of supplemental oxygen
Decrease in time to recovery
Decrease in time until hospital discharge
Preventing of respiratory failure
Restoring the base-line decreased lymphocytes count

→ “Clinical trial using MAF for hospitalized COVID-19 patients in Ukraine.”(PDF)