Monday, August 10, 2020
Two phase 3, randomized, placebo-controlled, double-blind clinical trials testing whether experimental monoclonal antibodies (mAbs) can prevent infection by SARS-CoV-2 coronaviruses, now clinical trials in the United States Enrolling healthy adults at sites. Many of the test sites and study investigators are part of the COVID-19 Prevention Network (CoVPN), recently established by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health. SARS-CoV-2 is the virus that causes coronavirus virus 2019 (COVID-19). The trials are enrolling adults who are at risk of infection due to close contact at work or home with individuals with SARS-CoV-2 infection.
Anthony S., director of NIAID. Fauci, MD said, “The COVID-19 Prevention Network is designed to operate on a large scale rapidly and efficiently.” This network will help us test the safety and efficacy of monoclonal antibodies and other preventive measures . How to identify the best to reduce SARS-CoV-2 infection levels and ultimately to end the COVID-19 pandemic. ”
Monoclonal antibodies are laboratory-produced versions of proteins naturally produced by the immune system in response to viruses or other pathogens. Natural or monoclonal, whether they inhibit starting the cycle of infection and can bind to parts of the virus they use to enter the cells, they neutralize antibodies. Monoclonal antibodies may provide short-term protection from SARS-COV-2 and serve as important components of the COVID-19 pandemic response until vaccines are available.
A trial is being conducted jointly by NIAID and trial sponsor Regeneron Pharmaceuticals of Trystown, New York. This will evaluate Regeneron’s investigative double mAb combination, REGN-COV-2, which is designed to bind to two points on the SARS-CoV-2 spike protein and prevent it from entering healthy cells. The trial will enroll approximately 2,000 asymptomatic adults who are domestic contacts of individuals with SARS-CoV-2 infection. Participants must be in close contact (usually due to staying at the same address) with either a person infected with a REGN-CoV-2 or a pre-infected 96-hour window of placebo. In addition to assessing safety, the test will try to define whether REGN-COV-2 can prevent symptoms of infection or disease in those already infected. The efficacy assessment will take place over a period of one month after administration of REGN-COV-2 or placebo. All trial participants will be followed for safety for seven months after the efficacy evaluation period ends.
Additional details about this test using the identifier NCT04452318 are available at Clintrials.gov. Interested participants can also go CoVPN website for details. The doctor or potential participant can contact the sponsor’s clinical trial administrator at 844-734-6643 [email protected] For enrollment information.
A second trial, sponsored by Eli Lilly and Indianapolis-based company Indiana, and implemented in collaboration with NIAID, will evaluate LY-COV555 from a COVID-19 patient recovered by scientists at ABC Calera (Vancouver, British Columbia, Canada) Isolated is a mAb. And NIAID Vaccine Research Center, and developed by Eli Lilly and Company. This test will assess whether LY-CoV555 can prevent SARS-CoV-2 infection in people at high risk of exposure due to living or working in skilled nursing or assisted living facilities. Within a week of identifying a case of SARS-CoV-2 infection at a facility, study investigators would enroll trial volunteers and evaluate the prevention efficacy and safety of LY-CoV555 compared to placebo over an 8-week period. The test will also evaluate efficacy to prevent symptoms of a given severity in previously infected people. Participants will be followed for security for an additional 16 weeks. Up to 2,400 participants will be randomized to receive intravenous infusion of LY-CoV555 or placebo.
Additional information about this test using the identifier NCT04497987 is available at Clintrials.gov. Clinical investigators, hospitals or clinical sites wishing to participate in one of Lily’s clinical trials for a potential COVID-19 treatment, 1-877-CT-Lily (1-877-285-4559) Or email [email protected]
NIAID supports and supports research at the NIH throughout the United States, and worldwide – to study the causes of infectious and immune-mediated diseases, and to develop better tools to prevent, diagnose and treat these diseases for. News releases, fact sheets and other NIAID related material are available on the NIAID website.
About National Institutes of Health (NIH):The NIH, the nation’s medical research agency, consists of 27 institutions and centers and is a component of the US Department of Health and Human Services. The NIH is the primary federal agency conducting and supporting basic, clinical and translational medical research, and investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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People over the age of 18 and who are willing to participate in these trials should visit the COVID-19 Prevention Network. Please do not contact the NIAID Media phone number or email to inquire about enrollment in the tests.