Efficacy, Safety of Baricitinib plus Remdesivir versus Standard Therapy (Remdesivir) in Patients with Severe COVID-19 Infection in Third Wave of Epidemics in Myanmar: Case Control Study

Abstract

Background: Coronavirus disease 2019 (COVID-19) has been a major threat to health around the world as it causes significant morbidity and mortality. SARS-CoV-2 infection induces severe inflammation in lungs and multi-organs; therefore, the Janus kinase (JAK) inhibitor known as baricitinib was proposed as a treatment for COVID-19 because of its anti-inflammatory and potential antiviral effects. It may improve survival in patients with severe Covid-19 infection. The efficacy and safety of Baricitinib therapy in severe COVID-19 infection in Myanmar was not known clearly. Methods: A case control study was conducted in COVID-19 treatment centers in Myanmar- Yangon and Nay Pyi Taw, from June to October 2021. Baricitinib 4 mg daily for 14 days was given to the patients with severe COVID-19 infection as an add on therapy to Standard treatment group (Remdesivir). The primary outcome was survival status; survive or non-survive. The secondary outcome was duration of hospital stay, the requirement for oxygen therapy at Day 7 (improved or not), changes in chest radiograph at Day 14 (improved, same or worse), and changes in inflammatory markers (CPR and LDH). Patient data were stratified by age, sex, body weight, co-morbidities and immune status (immunocompromised or normal immune status). Data were collected by using standardized forms and analysis was done. Results: A total of 64 patients with severe COVID-19 infection were enrolled. Base line characteristics in both groups, Baricitinib group (n =32) and Standard treatment group (n = 32), were comparable. Nearly 53% of patients in Baricitinib group and 59% of patients in Standard treatment group survived; however, mean duration of hospital stay was shorter in Baricitinib group (15.53 ± 6.83 days versus 22.25 ± 11.17 days; p < 0.001). Improvement in oxygen supplementation, radiological changes and changes in inflammatory markers were not different in both groups. Minor side effects like giddiness, appetite loss and insomnia were noted in Baricitinib group. Conclusions: In treating patients with severe COVID-19 infection, the survival rate was not different between Baricitinib group (Baricitinib plus Remdesivir) and Standard treatment group (Remdesivir). In survivors, those in Baricitinib group had shorter duration of hospital stays; quick recovery time and accelerating improvement in clinical status