BREAKING! COVID-19-Antibodies: Regeneron’s Clinical Trial For Severe COVID-19 Patients Suspended! Possible Adverse Reactions!
Source: COVID-19-Antibodies Oct 30, 2020 3 years, 5 months, 2 weeks, 2 days, 17 hours, 22 minutes ago
COVID-19-Antibodies: The independent data monitoring committee (IDMC) has recommended that Regeneron ‘s clinical trial of its antibody treatment called REGN-COV2 for severe COVID-19 patients needing oxygen or who are on ventilators be suspended with immediate effect. The decision was made in the last 24 hours and Regeneron was legally obliged to comply immediately.
On early Friday in the U.S., the American biotech firm Regeneron announced that it was suspending enrollment for a study of its COVID-19 antibody treatment among the sickest patients who require high-flow oxygen or are on ventilators. The sudden move follows a recommendation from an independent data monitoring committee (IDMC) which assesses the results and advises when it's necessary to halt a study.
However not much details were given to the media or press as to the actual reasons for this sudden decision. Some are saying that there were serious adverse reactions observed in severe patients taking the drug.
The company issues a media statement in the last few hours saying, "Based on a potential safety signal and an unfavorable risk/benefit profile at this time, the IDMC recommends further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending collection and analysis of further data on patients already enrolled.”
The company statement however added that the committee recommended that Regeneron continue to enroll hospitalized patients who either don't need oxygen or are on low-flow oxygen, and recommends the continuation of the outpatient trial.
The biotech company said it was informing the US Food and Drug Administration, which is currently evaluating the treatment, called REGN-COV2, for an emergency use authorization in mild-to-moderate outpatients at high risk for poor outcomes.
The company is also sharing its recommendation with the committee monitoring a separate RECOVERY trial in the UK which is evaluating REGN-COV2 in hospitalized patients.
The REGN-COV2 antibody drug was recently used to treat President Donald Trump on a so-called "compassionate use" basis.
Although there are no additional details about why the hospitalized trial for the sickest patients has been suspended, scientists have always believed that antibody treatments should work best when given early on in COVID-19.This is because they work by preventing the virus from invading human cells and replicating.
However by the time a patient has progressed to late-stage COVID-19, the main factor driving their illness is not the virus itself but an abnormal immune response that causes severe inflammation and organ damage.
Also that's why current guidelines recommend treating late-stage patients with steroids, which dial down the immune system.
It was said that the human immune system itself develops antibodies, but because not everyone mounts an adequate response, companies like Regeneron are working on synthetic solutions.
The company found two antibodies that were highly effective against the SARS-CoV-2 virus, one from a mouse with a human-like im
mune system, the other from a human then harvested the cells that secreted them and grew them in a lab, to create a mass treatment combining the two.
The concept was seen as promising and the company recently received full regulatory approval for a similar treatment against the Ebola virus after it was proven to be safe and work well.
It was said that Regeneron has received more than US$450 million from the Trump Adminstration for its COVID-19 drug development efforts.
Sources close to the clinical trials and also the development of the drug speculate that the treatment protocol is most probably another scam like Remdesivir as there is actually no proper proven efficacy. they said that the cash rich biotech company however is able to buy up researchers, manipulate study findings and also medical journals etc. More importantly they already had the tainted and lying President Trump of the United States to indirectly endorse their product.
It will be little wonder that it will be another drug product that will be approved by the Trump controlled U.S. FDA.to treat COVID-19.
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