Evaluation of the safety and efficacy of isotretinoin in treatment of COVID-19 : A randomized controlled clinical trial.

Abstract

The pandemic of SARS-CoV2 is not only limited to the health issues and fatalities encountered in a worldwide overwhelming burden but also the social, economic, and well-being devastation. Many trials were done to find a safe and reliable therapy for COVID-19. Isotretinoin was reported as a possible therapy for COVID-19 through the mining of post-transcriptomic and genomic datasets, which revealed isotretinoin as a potent down-regulator of the ACE2 protein the crucial gateway of SARS-CoV2 to hijack host cells. A total of 106 patients with mild to moderate COVID-19 were recruited. Patients were randomized into two groups and treated with the Standard Care (STD) protocol of the Ministry of Health, Egypt, or the STD in combination with isotretinoin (0.5 mg/kg/day) for 5 days. The study involved 66 (63 %) females and 39 (37 %) males, median age 42 years (interquartile 32-55.5 y). The main findings revealed a significant reduction in the time to improvement in the isotretinoin-treated (6.6 ± 2 d) compared to the STD-treated patients (10.4 ± 3.3). Survival analysis (HR: 4.1, 95 % CI: 2.5-6.6) in comparison to the STD-treated patients. The main adverse event reported during the therapeutic duration was the dryness of the skin, which was of acceptable tolerability through skin care instructions to the patients. The data presented herein highlights the efficacy of isotretinoin in the management of mild to moderate COVID-19 patients with a significant reduction of the time to recovery. The adverse events reported were tolerable and did not outweigh the therapeutic benefits.