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The European Medicines Agency (EMA), which regulates drugs in the EU, on March 22 decided not to recommend the use of anti-parasitic drug Ivermectin for COVID-19 treatment.
Ivermectin is used in treating Malaria.
However, the EU drug regulator allowed the use of Ivermectin in well-designed clinical trials.
The Europe drug regulator decision comes following the review of all the evidence from laboratory studies, observational studies, clinical trials and meta-analyses.
In February this year, the US National Institute of Health (NIH), after a review of evidence said that there was insufficient data to recommend either for or against the use of Ivermectin for the treatment of COVID-19.
It further said results from "adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of Ivermectin in the treatment of COVID-19."
Ivermectin, the anti-parasitic drug has been widely used in India and many other countries as off-label medication to treat mild and moderate COVID-19 patients, despite limited evidence of its efficacy.
While Ivermectin is not included in the COVID-19 Clinical Management Protocol, that's not stopping physicians and hospitals from using it. For instance, West Bengal government's COVID-19 protocol released on September 25, 2020, allows the use of Ivermectin and doxycycline combination for treating mild-moderate COVID-19.
The West Bengal government asks physicians to share clinical records and data regarding the use of Ivermectin with the state, as clinical trials of the drug are going on.
How did Ivermectin shoot to fame?
Ivermectin, which is an age old drug used for parasitic worm infestations like head lice, has shot to limelight during the COVID-19, as in-vitro studies suggest that the drug in certain doses can kill SARS-CoV-2 virus.
Ivermectin is known to have broad spectrum antiviral properties. Broad spectrum means it can kill or block a host of viruses.
William C. Campbell and Satoshi Omura have jointly won the Nobel Prize in Physiology or Medicine 2015 for discovering Ivermectin.
Medical experts divided
Dr. Rahul Pandit, Director of Director-Critical Care, Fortis Hospitals Mumbai says he has never used Ivermectin to treat COVID-19 patients.
"There is little scientific evidence that this drug works against COVID-19, like Hydroxychloroquine it gained prominence for having antiviral properties," Pandit said.
Another doctor who treated COVID-19 patients but didn't want to be named said he found Ivermectin along with doxycycline beneficial to patients as "it cleared virus much faster."
To be sure, the results from clinical trials are mixed. Some clinical studies showed no benefits or worsening of disease after Ivermectin use, while others reported shorter time to resolution of disease, greater reduction in inflammatory markers, and lower mortality rates in patients who received it than in patients who received comparator drugs or placebo.
The debate on Ivermectin is not settled yet.
The US-based Front Line COVID-19 Critical Care Alliance (FLCCC), that counts some of the top critical care specialists as its members, said 16 randomised controlled trials (totaling over 2,500 patients), the majority have reported a statistically significant reduction in transmission or disease progression or mortality.
"Further, a meta-analysis recently performed by an independent research consortium calculated the chances that Ivermectin is ineffective in COVID-19 to be 1 in 67 million. The FLCCC Alliance, based on the totality of the existing evidence, supports recommendation for the use of Ivermectin in both the prophylaxis and treatment of all phases of COVID-19," FLCCC said early this year.