LAUSR

Objectives To study the efficacy and safety of Withania somnifera (WS) in the prophylaxis against COVID-19 in high risk health care workers (HCW) in comparison to hydroxychloroquine (HCQ). To evaluate general physical and mental health benefits of Ashwagandha. Methods A 16 week randomized prospective, open label, parallel efficacy, two arm multi-centre study. The primary efficacy measure is ‘failure of prophylaxis’ as confirmed COVID-19 by quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) at any time during the study period. This study on 400 participants from three centres is designed to establish non-inferiority for WS to HCQ for prophylaxis against COVID-19 at 80% power and significance P < 0.025, one sided. The interim analysis was carried out on 160 participants after completion of 8 weeks. Results Participants in both the arms were well matched at the baseline characteristics. 40 participants in the HCQ group and 26 participants in the WS group reported mild AE. The symptoms of confirmed COVID-19 were found to be 3.7% (95% CI 1.3 to 10.5%) in the HCQ and 1.3% (95% CI 0.02 to 6.7%) in the WS arm amongst the first 160 participants completing 8 weeks. Conclusion Our intent was to explore a safer option to HCQ. We report that WS was not found inferior to HCQ and its efficacy was within the 15% non-inferiority margin set a-priori. WS as immunomodulator has other clinical benefits including reducing mental stress. Final report of this study is expected by end of August 2021. Trial registration CTRI/2020/08/027163 [Registered on: 14/08/2020].