MLC901 in hypoxic-ischemic brain injury patients: A double-blind, randomized placebo-controlled pilot study.

BACKGROUND: Hypoxic-ischemic brain injury (HIBI) is a disabling consequence of cardiopulmonary resuscitation, which has no direct treatment except supportive care. Many studies have used pharmacological agents to reduce or stop this disability. MLC901 is a traditional Chinese medicine showing neuroprotective and regenerative effects on focal and global ischemia in previous animal and human studies. We designed an experimental, randomized, double-blind, placebo-controlled study to analyze MLC901 efficacy in HIBI patients. METHODS: In a randomized, placebo-controlled trial, 35 patients with HIBI were randomly designated to receive either MLC901 or placebo capsules 3 times per day over 6 months. We assessed the 2 groups by modified Rankin Scale and Glasgow Outcome Scale at baseline, and follow-up visits in 3rd month, and 6th-month after injury. RESULTS: Thirty-one patients completed this study. There was no significant difference in baseline characteristics between the 2 groups as regards age, gender, time of resuscitation, the interval between injury and start of the intervention, and the length of intensive care unit stay. Both the placebo and intervention groups improved during the investigation. However, the Glasgow Outcome Scale and modified Rankin Scale scales were significantly improved in the MLC901 group compared to the placebo after 6 months (P < .05) with close to no adverse effects. No major side effect was reported. CONCLUSION: MLC901 has shown, compared to placebo, a statistically better improvement at 6 months in neurological functions of patients with HIBI.

Combined Therapy of Ciclosporin Plus Favipiravir in the Management of Patients with Severe COVID-19, not Responding to Dexamethasone: A non-Controlled Prospective Trial.

BACKGROUND: Regarding the COVID-19 pandemic, potential therapeutic agents are being evaluated almost every day. Ciclosporin, a calcineurin inhibitor, is characterized by beneficial antiviral and immunomodulatory effects. The present study aimed to evaluate the efficacy of ciclosporin in managing COVID-19. METHODS: This study was a prospective non-controlled clinical trial carried out on 20 patients. Confirmed COVID-19 patients received two doses of ciclosporin (10 mg/kg and 5 mg/kg injections) 24 h apart. Mortality rate and the lengths of intensive care unit (ICU) and hospital stays were assessed for all 20 patients. RESULTS: The mortality rate and the need for mechanical ventilation were calculated as 50%. The percentage of ICU admission was 70%. The lengths of ICU and hospital stays were 8.13 ± 6.81 and 14.25 ± 8.55 days, respectively. The levels of ferritin and white blood cells were significantly higher after injecting the second dose of ciclosporin. Seven patients (35%) had radiologically improved lungs after ciclosporin therapy. CONCLUSION: It seems that the protocol of two doses of ciclosporin in combination with favipiravir does not have favorable effects among COVID-19 patients that do not respond to dexamethasone. Controlled trials are needed to confirm the results.

Efficacy and Safety of MLC601 in Patients with Mild to Moderate Alzheimer Disease: An Extension 4-Year Follow-Up Study.

BACKGROUND AND AIM: Alzheimer disease (AD) is the most common cause of dementia. Currently, there is no disease-modifying therapy for AD. We aimed to evaluate the long-term efficacy and safety of MLC601 in the treatment of AD. METHODS: In this open-label extension study, patients with mild to moderate AD according to DSM-IV criteria were recruited. Patients received MLC601 capsules 3 times a day for 4 years. Cognitive function was assessed every 6 months using Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) scores. Safety profiles, including adverse events (AEs), and treatment-related abnormality in laboratory tests were also reported. RESULTS: Of a total of 122 patients, 105 completed the study. The mean age was 66.8 ± 6.3 years at the beginning of the study. Sixty-five (61.9%) were female. The mean (±SD) change in MMSE and ADAS-Cog scores at the end of the study was 2.1 (±3.8) and -5.1 (±8.7), respectively. Repeated measure analysis revealed a statistically significant change in both scores (p < 0.001). No patient left the study due to an AE. No abnormality was noted in lab tests. Gastrointestinal symptoms were the most commonly reported AEs. CONCLUSION: The efficacy of treating AD patients with MLC601 over 4 years has been demonstrated in the present study. Overall, it seems that the safety and efficacy of MLC601 is promising compared to currently prescribed treatments.