8-Gram Dose of COVID-19 Antibody Cocktail Provided to President Trump
New York based Regeneron Pharmaceuticals, Inc. confirmed that the company provided a single 8-gram dose of REGN-COV2 for use by the US President Donald J. Trump.
Regeneron’s statement published on October 2, 2020, says ‘REGN-COV2 is an investigational COVID-19 therapy, which was provided in response to an Individual Patient Investigational New Drug application request submitted by the President’s physicians.
More than 2,000 people have been enrolled across the overall REGN-COV2 development program to date, and no unexpected safety findings have been reported by the Independent Data Monitoring Committee, stated the company.
On September 30, 2020, Regeneron announced early data showing a reduction in viral levels and improved symptoms with REGN-COV2 treatment in non-hospitalized COVID-19 patients.
Commonly known as a ‘compassionate use program,’ Regeneron’s program has established criteria and review committee. As a matter of policy, the company does not disclose whether an individual has or has not submitted a request for compassionate use, without their consent or prior disclosure.
The company’s current priority is to maintain a sufficient supply of REGN-COV2 in order to conduct rigorous clinical trials that fully evaluate its safety and efficacy. In addition to the clinical trial supply and the product being manufactured under an agreement with the U.S.government, there is a limited product available for compassionate use requests that have been approved under rare, exceptional circumstances on a case-by-case basis.
Requests for compassionate use must be initiated by a treating physician.
Clinical trials are actively enrolling hospitalized and non-hospitalized patients, as well as people at risk of infection who have had close household exposure to a COVID-19 patient.
Individuals interested in participating in one of Regeneron’s COVID-19 clinical trials may complete a brief online screener at ClinLife.com/COVID to see if they qualify.
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.
To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.
Regeneron is a leading biotechnology company based in the state of New York, that invents life-transforming medicines for people with serious diseases.
PrecisionVaccinations publishes research-based COVID-19 treatment news.