Clevira, a drug primarily developed to treat dengue, has been repurposed as supportive treatment for mild to moderate COVID-19 cases, its manufacturer Apex Laboratories Private Limited said on Friday.
The drug is effective when taken orally and the dosage is one tablet twice daily after food for 14 days. The drug has also proved to be safe on liver and kidney parameters, it said.
"Clevira, an antiviral formulation, has received regulatory approval as a supportive treatment for mild to moderate COVID-19 cases," the Chennai-based pharmaceutical company said.
"Clevira was developed primarily to treat dengue patients in 2017. Last year, as the COVID-19 cases surged in the country, it was repurposed as supportive treatment for mild to moderate coronavirus symptoms. The product is available across India and is priced at Rs 11 per tablet," the company said.
A clinical trial was conducted on 100 people in May-June last year and the results were "promising", it said.
The selected 100 participants were randomised into two groups with 50 patients each during the 30 day-trial conducted at Government Medical College Omandurar and Government Estate in Chennai after approval from the Tamil Nadu government.
The control group comprised patients diagnosed with SARS-CoV-2 infection and received standard care treatment as per hospital regulation as well as the WHO/Indian Council for Medical Research (ICMR) guidelines.
The test group patients also received Clevira tablets twice daily orally after food for 14 days.
"It was found that Clevira significantly reduced the time taken for clinical recovery, which was noted in terms of reduction in pyrexia or body pain, normalisation of the respiratory rate (less than 24/minute) and improvement in oxygen saturation level (more than 94 per cent)," the company said.
Besides 86 per cent of patients tested negative for the infection on (day 5) and 100 per cent of patients turned out to be COVID-19 RT-PCR test negative on (day 10) after consuming Clevira tablets.
The clinical trial results were submitted to the Tamil Nadu government, ICMR and the Ministry of AYUSH in 2020.
"After rigorous scrutiny and deliberations, the drug got approval to be used as a supporting measure for treating mild to moderate COVID-19 symptoms by the Ministry of AYUSH regulators, a first-of-its-kind approval in India through various stages of scrutiny at the Central Council for Research in Ayurvedic Sciences (CCRAS) and the Interdisciplinary Technical Review Committee (ITRC)," the company said.
C Arthur Paul, Manager International Business, Apex Laboratories, said, "The antiviral drug increases the white blood cell (WBC), platelet and lymphocyte counts significantly within the normal range apart from reducing the viral load, hence the recovery from all signs and symptoms is much faster." Significant reduction in Erythrocyte Sedimentation Rate (ESR) is evident that the drug elicits anti-inflammatory property, he said.
"Clevira is proven effective as an analgesic, antipyretic and reversal of thrombocytopenia. It is absolutely safe for people with liver or kidney ailments and can be safely co-administered with other drugs. It can also be used as a prophylactic treatment for primary contacts of COVID-19 positive patients and frontline healthcare workers," the official noted.
The drug is recommended for all age groups from the age of 2 years, Paul added.
The company said the drug is available across India.