Clevira, a drug primarily developed to treat dengue fever, has been reused as a 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 a day after meals for 14 days. The drug was also found to be safe on liver and kidney parameters, he 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 fever patients in 2017. Last year, as COVID-19 cases increased in the country, it was reused as a supportive treatment for mild to moderate coronavirus symptoms The product is available all over 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,” he said.
The 100 selected participants were randomized into two groups of 50 patients each during the 30-day trial conducted at Government Medical College Omandurar and Government Estate in Chennai after approval from the government of Tamil Nadu.
The control group included patients diagnosed with SARS-CoV-2 infection and receiving standard care treatment according to hospital regulations as well as WHO / Indian Council for Medical Research (ICMR ).
Patients in the test group also received Clevira tablets twice daily by mouth after a meal for 14 days.
“Clevira was found to significantly reduce the time required for clinical recovery, which was noted in terms of reduced pyrexia or body pain, normalization of respiratory rate (less than 24 / minute) and improved oxygen saturation level (over 94 percent), ”the company said.
In addition to 86% of patients who tested negative for infection on (day 5) and 100% of patients tested negative for the COVID-19 RT-PCR test on (day 10) after consuming Clevira tablets.
The results of the clinical trials were submitted to the government of Tamil Nadu, ICMR and the Ministry of AYUSH in 2020.
“After rigorous review and deliberation, the drug was approved for use as a supportive measure for the treatment of mild to moderate symptoms of COVID-19 by AYUSH Ministry regulators, a first-of-its-kind approval in India at through different stages of control. to the Central Council for Ayurvedic Science Research (CCRAS) and the Interdisciplinary Technical Review Committee (ITRC), ”the company said.
C Arthur Paul, Director of International Affairs, Apex Laboratories, said: “The antiviral drug increases the number of white blood cells (WBCs), platelets and lymphocytes significantly in the normal range apart from the reduction in viral load. hence the healing of all signs and symptoms is much faster. “A significant reduction in the rate of erythrocyte sedimentation (ESR) is evident as the drug triggers an anti-inflammatory property,” he said.
“Clevira has been shown to be effective as a pain reliever, fever reducer and reverser of thrombocytopenia. It is absolutely safe for people with liver or kidney disease 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 health workers, ”the official noted.
The drug is recommended for all age groups from 2 years old, Paul added.
The company said the drug is available across India.