A randomized, controlled, blinded, parallel group, clinical trial to study the role of Ayurcov (AyurCoro3), one day regimen as an adjuvant therapy for COVID-19 disease management, at dedicated Covid Hospital (DCH) in India.

ABSTRACT

INTRODUCTION: Limited treatment options exist for COVID-19 infections; thus, attempts from complementary and alternative systems (CAM) of medicine are being explored as possible therapeutic options. Ayurcov is a formulation made of ingredients mentioned in Ayurveda. These constituents have proven antiviral, detoxifying, immune-modulating, and bio-enhancing properties. The present study was carried out to evaluate the therapeutic effect and safety of Ayurcov in patients with various severity states of COVID-19 infections. METHODS: A randomized, single blinded, controlled trial was carried out in adults diagnosed with mild-to-moderate, and severe COVID-19 infections confirmed by real time reverse transcriptase polymerase chain reaction (rRTPCR) test. The interventional group received three doses of 'Ayurcov'. It is constituted of Haridra Churna (Curcuma longa), Go ark (Bos Indicus Distilled Urine), Sphatika (Alum), Sita (Rock Candy), Godugdham (Bos Indicus Milk) milk, Goghritam (Bos Indicus ghee) on Day 1, as an adjuvant to the standard of care, and the control group received only the standard of care. Key outcomes included proportion of patients and time taken for symptom resolution, reduction in the rRT-PCR Ct values, safety, and functional status until 42 days after discharge. RESULTS: Ninety patients with mild-to-moderate and 30 patients with severe COVID-19 disease were recruited. It was observed that significantly more proportions of patients receiving Ayurcov had symptom relief much earlier than control group. Additionally, the interventional group showed significantly lower rRT-PCR Ct values. However, a shorter time of resolution of symptoms was observed with the interventional group in the mild to moderate category but not with those having severe symptoms. Similarly, a significantly better functional status was observed with interventional group on days 7 and 28 after discharge. Ayurcov was not observed with higher risks of any adverse/serious adverse events. CONCLUSIONS: Ayurcov as adjuvant with standard of care was associated with significantly earlier resolution of COVID-19 related symptoms than standard of care alone.