Publication date: Jun 06, 2025

The study was planned when, the hydroxychloroquine (HCQ) was the only prophylactic agent approved by health authorities in several countries and no prophylactic COVID-19 vaccine was available. The present study aimed to evaluate efficacy of Withania Somnifera (L. ) Dunal (WS) as a chemoprophylactic and immunomodulatory agent against SARS-CoV-2 infection. In a 12 week, randomized, open label, parallel group, two arm, comparative, multicentric, controlled trial compared WS with hydroxychloroquine (HCQ) in health care workers (HCWs). Total 400 HCWs were randomized in 1:1 ratio to receive either oral WS (500 mg for 12 weeks) or HCQ 400 mg (for 7 weeks). The primary outcome was to establish equivalence between WS and HCQ for the proportion of participants contracting SARS-CoV-2 infection. Seven participants contracted SARS-CoV-2 infection: 5 in WS arm and 2 in HCQ arm. The equivalence between WS and HCQ was established for the proportion difference of participants contracting SARS-CoV-2 infection for per-protocol (PP) (1. 6%, 95% CI: -1. 08%-4. 33%) and in subgroup analysis (ITT, mIIT, non-vaccinated and seronegative). Notably, the immunomodulatory effect of WS stood scientifically validated by the statistically significant difference in cytokine levels (p

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