White House Physician Sean P. Conley in a memorandum prepared for White House Press Secretary Kayleigh McEnany, has revealed that President Donald Trump has received a single 8- gram dose of an experimental monoclonal antibody drug invented by Tarrytown-based pharmaceutical company Regeneron in the fight to keep the president’s case of Covid-19 under control.
Trump was due to be transferred shortly after 5:30 p.m to Walter Reed National Military Medical Center for observation and treatment. He was earlier said to be having mild symptoms of Covid, rather like those of a cold. Later, it was revealed that he had developed a fever.
Conley, who is a U.S. Navy doctor assigned as the president’s physician, also revealed that the president has been taking zinc, vitamin D, melatonin, famotidine and aspirin.
When asked by the Business Journal, Regeneron confirmed that, as announced by the White House physician’s memo, Regeneron provided a single 8-gram dose of REGNCOV2, a cocktail of two monoclonal antibodies, for use by Trump. REGN-COV2 is an investigational COVID-19 therapy that was provided in response to an Individual Patient Investigational New Drug (IND) application (commonly known as ”˜compassionate use”™ request) from the President”™s physicians.
Regeneron said it has a compassionate use program with certain established criteria and review committee. As a matter of policy, the company does not disclose whether any individual has or has not submitted a request for compassionate use without their consent or prior disclosure.
The company said that its 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 product being manufactured under an agreement with the U.S. government, there is 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.
REGN-COV2 is being evaluated for both the treatment and prevention of COVID-19. 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.
Earlier this week, Regeneron announced early data showing a reduction in viral levels and improved symptoms with REGN-COV2 treatment in nonhospitalized COVID-19 patients.
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. 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.
