“Clevira, an antiviral formulation, has obtained regulatory approval as a supportive therapy for delicate to average Covid-19 circumstances,” the Chennai-based pharmaceutical company stated.
“Clevira was developed primarily to deal with dengue sufferers in 2017. Final 12 months, because the Covid-19 circumstances surged within the nation, it was repurposed as supportive therapy for delicate to average coronavirus signs. The product is obtainable throughout India and is priced at Rs 11 per pill,” the corporate stated.
A scientific trial was carried out on 100 folks in Could-June final 12 months and the outcomes have been “promising”, it stated.
The chosen 100 contributors have been randomised into two teams with 50 sufferers every in the course of the 30 day-trial carried out at Authorities Medical Faculty Omandurar and Authorities Property in Chennai after approval from the Tamil Nadu authorities.
The management group comprised sufferers recognized with SARS-CoV-2 an infection and obtained customary care therapy as per hospital regulation in addition to the WHO/Indian Council for Medical Analysis (ICMR) pointers.
The take a look at group sufferers additionally obtained Clevira tablets twice every day orally after meals for 14 days.
“It was discovered that Clevira considerably decreased the time taken for clinical recovery, which was famous by way of discount in pyrexia or physique ache, normalisation of the respiratory fee (lower than 24/minute) and enchancment in oxygen saturation stage (greater than 94 per cent),” the corporate stated.
In addition to 86 per cent of sufferers examined adverse for the an infection on (day 5) and 100 per cent of sufferers turned out to be Covid-19 RT-PCR take a look at adverse on (day 10) after consuming Clevira tablets.
The scientific trial outcomes have been submitted to the Tamil Nadu authorities, ICMR and the Ministry of AYUSH in 2020.
“After rigorous scrutiny and deliberations, the drug bought approval for use as a supporting measure for treating delicate to average Covid-19 signs by the Ministry of AYUSH regulators, a first-of-its-kind approval in India by way of numerous phases of scrutiny on the Central Council for Analysis in Ayurvedic Sciences (CCRAS) and the Interdisciplinary Technical Overview Committee (ITRC),” the corporate stated.
C Arthur Paul, Supervisor Worldwide Enterprise, Apex Laboratories, stated, “The antiviral drug will increase the white blood cell (WBC), platelet and lymphocyte counts considerably inside the regular vary aside from decreasing the viral load, therefore the restoration from all indicators and signs is way quicker.”
Vital discount in Erythrocyte Sedimentation Price (ESR) is clear that the drug elicits anti-inflammatory property, he stated.
“Clevira is confirmed efficient as an analgesic, antipyretic and reversal of thrombocytopenia. It’s completely protected for folks with liver or kidney illnesses and may be safely co-administered with different medicine. It can be used as a prophylactic therapy for main contacts of Covid-19 constructive sufferers and frontline healthcare staff,” the official famous.
The drug is advisable for all age teams from the age of two years, Paul added.
The corporate stated the drug is obtainable throughout India.