Almost as fast as the news spread that US President Donald Trump had contracted COVID-19, the fame of the experimental cocktail of the pharmaceutical company Regeneron that has been administered to him has spread and he has now promised to give emergency approval and distribute it free to Americans.
The investigational cocktail REGN-COV2 developed by Regeneron has already gone through phases 1, 2 and 3 of the trial and has been tested on 275 patients, all with COVID-19 confirmed by a laboratory test, according to preliminary data released by the company in a statement on September 29.
According to the pharmacist, REGN-COV2, whose development and manufacture has been funded with U.S. federal funds, “is a combination of two monoclonal antibodies” and was “designed specifically to block the infectious power of SARS-CoV-2, the virus that causes COVID-19.
In releasing the first data from the trial, Regeneron said the investigational cocktail “reduces viral load and symptom relief time in non-hospitalized patients with COVID-19,” while showing “positive trends in reducing doctor visits.
The participants were divided into three groups: one who received (like Trump) a single dose of 8 grams, considered the highest; another who was given an infusion of 2.4 grams; and a third who was given a placebo.
“The greatest benefit of the treatment was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the natural immune response,” explained the president and scientific director of Regeneron, George D. Yancopoulos.
In other words, patients with an absence of antibodies against the virus or with higher viral levels had greater benefits in the relief of symptoms, with an average time of 13 days, which varied between eight for patients with the highest dose and six with the lowest.
According to the U.S. Food and Drug Administration (FDA) regulator in charge of approving the drugs, “compassionate use” allows access to experimental drugs for patients whose lives are in danger.
Until the FDA approves the drug, the only way to access that treatment is to volunteer for clinical trials.