NYU Langone Health

NYU Langone Among First to Enroll Patients In Clinical Trial for COVID-19 Monoclonal Antibody Treatment

Newswise — The first patients were treated as part of a clinical trial testing whether an antibody therapy can safely reduce COVID-19 disease severity. The experimental treatment consists of identical copies of an antibody, a blood protein related to those that occur naturally as part of the human immune system, researchers say.

Eli Lilly and Company announced the trial’s start today, with NYU Grossman School of Medicine among the first centers to enroll patients nationally. The phase 1 clinical trial is designed primarily to measure the safety and side effects of the treatment, called LY-CoV555, in patients hospitalized due to infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).   

Lilly is developing the treatment in collaboration with AbCellera, which used its proprietary drug discovery technology to analyze antibodies from patients that recovered from COVID-19. They sought to find the antibodies which most tightly attached to the virus in places known to block its ability to infect human cells (neutralizing antibodies).

Beyond emergency and supportive care, there are currently no FDA-licensed treatment options for coronavirus disease 2019 (COVID-19), the infection caused SARS-CoV-2.

“We are committed to working with our industry partners to generate scientific evidence from randomized, controlled trials to meet the urgent need for treatments that reduce the severity of COVID-19 disease,” says Mark J. Mulligan, MD, director of the Division of Infectious Diseases and Immunology and director of the Vaccine Center at NYU Langone Health.

“Antibody treatments like the one being studied here hold promise to be effective medical countermeasures against this deadly infection,” says Mulligan, also the Thomas S. Murphy, Sr. Professor in the Department of Medicine at NYU Langone.

Along with Cedars-Sinai Medical Center and Emory University, NYU Langone was chosen as one of the first trial centers because it is known for its clinical trials expertise and capacity to rapidly initiate crucial studies, he adds.

“The world urgently needs medicines that can prevent and treat COVID-19,” says Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories. “We’re pleased to partner with NYU Langone and other expert centers around the country on this study and are hopeful we can make a meaningful difference in the fight against COVID-19.”

The current treatment candidate was chosen because it is shaped to interact with the “spike proteins” used by SARS-CoV-2 to attach to human cell surfaces, the first step in invading cells, say the investigators. Viruses must enter cells to multiply and the study treatment is meant to prevent such entry and neutralize the virus. 

Study Details

This randomized, blinded, placebo-controlled, first-in-human study aims to test the safety and tolerability of a single, intravenous dose of LY-CoV555 to hospitalized participants. The study will also look at how long the drug candidate lasts in the body.

Women and men aged 18 to 75 years are eligible for the study if they have moderate to severe COVID-19 illness according to National Institutes of Health (NIH) definitions, but not patients at high risk for respiratory failure, the researchers say. Patients will be excluded for several reasons, including if they require intubation (disease too severe), are pregnant, or have serious bacterial of fungal infections.

The study will proceed in stages, with two patients at first randomized to receive by infusion either the lowest dose of LY-CoV555 or placebo. If the drug is safe in that pair after 24 hours, six additional patients will be treated. If the lowest dose level in those eight patients is well tolerated and safe, a group of eight additional patients would be randomized to receive a slightly higher dose or placebo, with the process repeating for a potential total of up to 32 patients infused over 29 days.                                                                                                                          

If the treatment proves to be safe at each increasing dose, Lilly plans to pivot to the start of a phase II trial, pending regulatory approval, with the potential to test the treatment’s safety in a larger group of patients, including those that have not been hospitalized.  


Filters close

Showing results

110 of 4219
Released: 4-Dec-2020 4:30 PM EST
New review confirms disproportionate impact of COVID-19 on Black, Hispanic populations
Oregon Health & Science University

Black and Hispanic populations are disproportionately affected by COVID-19, according to a systematic review published this week.

Newswise: 250647_web.jpg
Released: 4-Dec-2020 4:05 PM EST
For nationalistic regimes, similar COVID-19 policies are the sincerest form of flattery
University of Texas at Arlington

Analysis from a University of Texas at Arlington assistant professor of public policy suggests that nationalistic governments around the globe are more likely to copy other nationalistic governments in responding to the current pandemic.

Released: 4-Dec-2020 3:15 PM EST
New Study Finds Once Hospitalized, Black Patients with COVID-19 Have Lower Risk of Death than White Patients
NYU Langone Health

A team of investigators at NYU Langone Health has found that once hospitalized, Black patients (after controlling for other serious health conditions and neighborhood income) were less likely to have severe illness, die, or be discharged to hospice compared to White patients.

Released: 4-Dec-2020 2:35 PM EST
AANA Commends CDC on Prioritizing COVID-19 Vaccine Distribution to Healthcare Personnel
American Association of Nurse Anesthetists (AANA)

The American Association of Nurse Anesthetists (AANA) commends the U.S. Centers for Disease Control and Prevention’s (CDC's) team of advisors on prioritizing frontline healthcare personnel and residents of long-term facilities for the first phase of the COVID-19 vaccine distribution.

Released: 4-Dec-2020 1:50 PM EST
COVID-19 in Victorian schools and childcare mainly driven by community transmission
Murdoch Childrens Research Institute

Analysis of Victorian data by the Murdoch Children's Research Institute suggests that COVID-19 cases in schools and childcare were mainly driven by community transmission

Released: 4-Dec-2020 12:20 PM EST
Identifying markers of COVID-19 infection using blood tests
University of Seville

Researchers from the Institute of Biomedicine of Seville (IBIS) have presented a study carried out in the Clinical Biochemistry Service of the Virgen del Rocío University Hospital which identifies the values for six biochemical biomarkers that indicate a patient may be infected with SARS-COV-2 (COVID-19).

Released: 4-Dec-2020 12:05 PM EST
Research confirms crucial monitoring assessment is effective for patients with COVID-19
University of Portsmouth

A combined research team from the Universities of Portsmouth and Bournemouth and Portsmouth Hospitals University NHS Trust has shown that an assessment score used to measure a patient's severity of illness can be applied to patients with Covid-19 without modification.

Newswise:Video Embedded flccc-alliance-calls-on-national-health-authorities-to-immediately-review-medical-evidence-showing-the-efficacy-of-ivermectin-for-the-prevention-of-covid-19-and-as-an-early-outpatient-treatment
Released: 4-Dec-2020 12:00 PM EST
FLCCC Alliance Calls on National Health Authorities to Immediately Review Medical Evidence Showing the Efficacy of Ivermectin for the Prevention of COVID-19 and as an Early Outpatient Treatment
Front Line COVID-19 Critical Care Alliance (FLCCC Alliance)

“Following the swi. review— and subsequent guidance— by the NIH and theCDC of Ivermectin, we expect that Ivermectin’s widespread, immediate use willallow for a rapid and safe re-opening of businesses and schools across the nation—and quickly reduce the strain on overwhelmed ICUs.” —FLCCC Alliance

Released: 4-Dec-2020 11:50 AM EST
Immunity passports: Ethical conflict and opportunity
University of the Basque Country

Immunity passports are a means of registering whether an individual has developed immunity to COVID-19 and is therefore unlikely to either catch or spread the disease.

Showing results

110 of 4219