In the present study, the combination of two tablets, one with Aspirin and Promethazine and the other with vitamin D3, C, and B3 along with zinc and selenium supplementation was proposed as an intervention (APMV2020). The ingredients in the formulation represent a precise, tailored therapy for the symptoms of COVID-19, combined with natural constituents to help the body itself build immunity to recover from infection. The present study was conducted to clinically validate the safety and efficacy of the APMV2020 tablets. The present trial is a randomized, multicentric, controlled clinical trial involving 260 mild to moderate COVID-19 patients. The treatment duration was of 10 days. The subjects were randomized to receive either the control intervention (clinical management protocol for COVID-19 advocated by the Indian Council of Medical Research (ICMR) or the test intervention (treatment with APMV2020 tablets along with the standard control treatment. The assessment days were baseline, days five and 10. APMV2020 significantly (<0.05) improved symptoms of COVID-19 like cough, myalgia, headache, and anosmia as compared to the control group. APMV2020 treatment also reduced inflammatory markers like lactate dehydrogenase (LDH), ferritin, and C-reactive protein (CRP). APMV2020 can prove as a good candidate to be integrated into the COVID-19 management protocol. As it can offer speedy clinical recovery to reduce the burden on healthcare infrastructure, second, the combination shows significant anti-inflammatory potential to improve prognosis, and lastly, the immunomodulatory properties offer long-term protection that can help in combating long COVID symptoms and complications.
This article has been corrected to add a financial conflict of interest that was not previously disclosed at the time of submission and publication. The fourth author, Rohit Shelatkar, is employed by Vitabiotics Ltd. working in departments for new product development, clinical trials, and consumer trials. The study product in this article was manufactured by the study sponsor, Meyer Organics Pvt. Ltd. Meyer Organics Pvt. Ltd is part of Vitabiotics Ltd. While Rohit Shelatkar's affiliation was correctly included, this connection between the study sponsor, Meyer Organics Pvt. Ltd, and Dr. Shelatkar's employer, Vitabiotics Ltd. should have been clearly disclosed. The authors sincerely regret this error of omission.