Clevira, an antiviral formulation receives GOIs regulatory approval as a supportive treatment for mild to moderate COVID-19 cases

India, 30 April 2021: Apex Laboratories Private Limited, a Chennai based pharmaceutical company known for its cutting-edge research and  innovation, introduces Clevira, an antiviral herbal formulation.

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 COVID symptoms.  The product is available across India and is priced at Rs 11 per tablet.

A clinical trial was conducted on 100 people in May-June 2020 and the results were promising.

During the 30 days trial, conducted at Government Medical College, Omandurar Government   Estate Chennai, after approval from the Tamil Nadu government, the selected 100 participants were randomized into 2 Groups with 50 patients in each: the control group comprised of patients diagnosed with SARS-CoV-2 infection received standard care treatment as per hospital regulation as well as the WHO/ICMR guidelines. The test group patients with SARS-CoV-2 infection received, along with standard care treatment (as per hospital regulation and the WHO/ICMR guidelines) 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), improvement in oxygen saturation level ( more than 94%), etc.

Besides, on treatment with Clevira, 86% of patients turned out to be COVID19 RT-PCR test negative on day 5 and 100% of patients turned out to be COVID19 RT-PCR test negative on day 10. Clinical improvement of signs and symptoms of COVID19 was achieved in 4.1 days.

Underlining about how supportive treatment can take the pressure off the already overwhelmed healthcare system, Ms. Subashini Vanangamudi the Executive Director, Apex laboratories Pvt Ltd  said “ Along with CAB, supportive treatment can also help in reducing the need for hospitalization among patients suffering from mild to moderate Covid-19 significantly. Even one patient less in the ICU means a lot during this crises, this would ensure better allotment of resources and medical attention for the needy. Its our duty to join hands in this fight against COVID-19.

Explaining the benefits and uses of Clevira, Mr C Arthur Paul, Manager International Business, Apex Laboratories, said, “The Antiviral drug increases the 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. 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 COVID19 positive patients and frontline healthcare workers.” The drug is recommended for all age groups from the age of 2 years.

On the availability of the drug, Mr Karthik  Shanmugam, Head of Marketing, Apex Laboratories Pvt Ltd, said, “The drug is already available in the market across India. Moreover, it would not only compliment the allopathic treatment but also reduce the huge socioeconomic burden the country is facing now, by improving the recovery rates. We have also priced the drug affordable, so that it reaches everyone in the society. Each tablet of Clevira costs only Rs. 11/.

The clinical trial results were submitted to the government of Tamil Nadu, Indian Council of Medical Research (ICMR) and 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 Government of India (Ministry of AYUSH) regulators, a first of its kind approval in India through various stages of scrutiny at CCRAS (The Central Council for Research in Ayurvedic Sciences) and Inter-Disciplinary Technical Review Committee (ITRC),  a 12 member technical committee constituted by Ministry of AYUSH and headed by Dr.S.K.Maulik, former professor department of pharmacology AIIMS.

Clevira is extensively studied for its safety in animal model (Wistar rats) and efficacy in Human subjects in Phase II and III clinical trials. Clevira is an approved Antiviral formulation for the treatment of various viral infections including viral fever associated with or without thrombocytopenia. It is also proven for its efficacy as analgesic, antipyretic and reversal of thrombocytopenia apart from its antiviral property.

Clevira is effective when taken orally and the dosage is one tablet twice daily after food for 14 days.  It has also proved to be safe on Liver and Kidney parameters.