The drug, which could eventually work on coronoviruses the way Tamiflu reduces flu symptoms, is being rolled out in a clinical trial at Zuckerberg San Francisco General Hospital, one of several US sites Who are enrolling volunteers for the study.
The drug, created by the pharmaceutical company Eli Lilly, is a type of drug called monoclonal antibody that appears in preliminary studies to help people in the early or mild stages of the disease. If proven effective, this class of drugs can help people with less severe symptoms – most people who fall ill with coronovirus – recover. It can also help those who are ill, who stay out of the hospital, thus preserving the hospital’s precious capacity, and making those with the virus less contagious. Like Temiflu, it will be an antiviral that helps reduce the duration of symptoms.
The trial comes at a time when doctors and health officials are seeking treatment that can reduce the effects of COVID-19 and bridge the gap until a viable vaccine is available. Effective medicines can try again by convincing the public that if they become ill, they can be treated. Expert, Director of National Institute of Allergy and Infectious Diseases Drs. Including Anthony Fauci, it is estimated that the first vaccine is likely to receive FDA authorization in November or December. But it would take months for vaccines to be available to the millions of people who would need to be vaccinated to return to normalcy. In a virtual discussion with the Journal of the American Medical Association last week, Fauci said he believes monoclonal antibody treatments are “what we hope most” to serve as a bridge to the vaccine.
“When people detect COVID, most of them are not hospitalized because they don’t need to be, but they still feel substandard and can transmit to other people, and we have them There is nothing to give, ”Dr. Annie Lucekemeyer, an infectious disease specialist at UCSF and principal investigator of the study in San Francisco. “We ask them to take care of themselves and monitor their symptoms, but they do not have treatments that have been shown to work in outpatient. It is really important for us to offer something that keeps them out of the hospital, makes you feel better and reduces your transmission to others. ”
It is unclear whether such a drug, while effective in large studies, may be available to the public. In general, studies on some drugs can be completed faster and with fewer participants than studies on vaccines. Along with therapeutics, drugs are given to people who are already ill, and researchers often find out within weeks whether the drug helped. In vaccine trials, the vaccine should be given to many more people, and only a small number of them will be incidentally exposed to the virus; Researchers should wait and see if they can determine whether the vaccine helped prevent infection.
A separate trial for the same drug is also underway at UCSF for COVID-19 patients hospitalized. Lutkemeyer’s study focuses on patients who are not hospitalized.
Thus the drugs that have attracted the most attention so far as the onset of the epidemic have largely been for seriously ill patients. Antiviral remediesvir and the steroid dexamethasone, for example, have been shown to improve recovery or reduce death among hospitalized patients for COVID-19. While rampsavir is also being studied for outpatients, for the most part it has been given to very ill hospitalized patients because the supply is limited and because it should be given by IV infusion.
The Eli Lilly drug, LY3819253, which has no marketing name yet, is administered as a one-time infusion. It contains LY-CoV555 antibodies that are produced as a single antibody that is naturally produced by those who have recovered from the virus. In this way, it differs from convulsive plasma, which comes directly from patients who have recovered and are very ill hospitalized. Monoclonal antibodies work to reduce the amount of virus in one’s body, allowing the immune system to regrow and fight the rest.
Monoclonal antibody drugs have successfully treated cancer, HIV, respiratory viruses RSV and other diseases including Ebola.
Several other pharmaceutical companies are studying monoclonal antibody drugs for the treatment of COVID-19, including Merck and Regeron.
Stanford University Professor of Microbiology and Immunology Drs. Robert Seagal said, “I think the monoclonal antibody approach holds a lot of promise, but like everything else, we really need to do careful testing to see if it works.” “It can be used to prevent serious illness. It can be used to prevent infection. And if you are exposed, it can also be helpful in reducing the viral load, so the person who is infected will not transmit it to anyone else. This can make you less contagious. ”
Zuckerberg is the local enrollment site for the San Francisco General Hospital Study, which is coordinated by the AIDS Clinical Trial Group and sponsored by the National Institutes of Health. The operation is part of the taunting motion, the federal government’s push to develop coronovirus vaccines and therapeutics. The study is also enrolling volunteers at UCLA, UC San Diego and several other sites in the United States.
Volunteers do not have to be San Francisco General Hospital patients to participate, as long as they have detected coronovirus within the last 10 days and are not symptomatic. More information is available at riseabovecovid.com or by email at [email protected]
The study aims to recruit about 200 people in Phase 2, and, if the drug is shown to be effective, Phase 3 will be carried forward and 2,000 people will be enrolled, Lutkemeyer said.
On 16 September Eli Lilly announced data for its monoclonal antibody drug, indicating it was safe and well tolerated. In early-stage studies of the drug company that have not been peer reviewed, the drug reduced virus levels and reduced hospitalization. Regeneron posted similar data for its medication on Tuesday, reducing its viral load and reducing the amount of symptoms patients have.