Efficacy and safety of in asymptomatic and mild-to-moderate cases of coronavirus disease-19: A randomized controlled pilot study.

Background: Currently, there is no approved treatment for the management of coronavirus disease (COVID-19). Drug repurposing of existing medications could be a possible way to find out a novel therapeutic entity to combat the COVID-19.

Aim: To determine the clinical efficacy and safety of an Ayurveda intervention () in asymptomatic and mild-to-moderate cases of COVID-19.

Materials And Methods: This was an open-label randomized controlled pilot study with a sample size of 30 participants (15 in each arm). The participants were asymptomatic or mild to moderate cases of COVID-19. 500 mg twice daily for 10 days was administered in the study group and Hydroxychloroquine for 5 days in the control group. Paracetamol, Vitamin C, Multivitamin, and Zinc were also provided in the control group. The main outcome measures were to negative real-time reverse transcription-polymerase chain reaction (RT-PCR) assay for COVID-19, proportion of participants with negative RT-PCR for COVID-19 at 5 and 10 day, proportion of participants with clinical recovery, improvement in laboratory parameters, and incidence of adverse drug reaction/adverse event (ADR/AE). The results of RT-PCR and clinical recovery were compared between groups using Chi-square test. The data related to laboratory parameters were compared within group using paired sample -test/Wilcoxon signed-rank test and between groups using independent sample -test/Mann-Whitney test.

Results: The proportion of participants with negative RT-PCR for COVID-19 in the group (93.3%) was better as compared to the control group (66.6%) till 10 day of the study period. Though, the results are statistically not significant ( = 0.068). All the symptomatic patients in the group clinically recovered whereas one patient remained symptomatic in the control group on the 5 day. No symptoms of COVID-19 were observed at 10 day in both the groups. No ADR/serious adverse event were observed during the study period in either of the groups.

Conclusion: In this study on asymptomatic and mild to moderate cases of COVID-19, numerically better proportion of participants with negative RT-PCR assay for COVID-19 and reduced time to clinical improvement which requires confirmation through studies with larger sample size. Although, the study outcomes are statistically not significant which may be due to small sample size.