NEJM: clinical trial indicates monoclonal antibody lowered hospitalizations and emergency visits

October 29, 2020

COVID-19 (coronavirus) patients who were administered a novel antibody had fewer symptoms and were less likely to require hospitalization or emergency medical care than those who did not receive the antibody, according to a new study published in the The New England Journal of Medicine.

The multisite, Phase II clinical trial tested three different doses of LY-CoV555, a monoclonal antibody derived from the blood of a recovered COVID-19 patient. While the trial is ongoing, results from the interim analysis indicated a reduced viral load in outpatients with mild to moderate cases of COVID-19 at the 2,800-milligram dosage level, along with reduced rates of hospitalization and emergency medical care among patients at all dosage levels.

The study's co-first author, Peter Chen, MD, professor of Medicine and director of the Division of Pulmonary and Critical Care Medicine at Cedars-Sinai, said the results are promising.

"For me, the most significant finding was the reduction in hospitalizations," Chen said. "Monoclonal antibodies like this have the potential to reduce the severity of COVID-19 for many patients, allowing more people to recover at home."

Monoclonal antibodies work by attaching themselves to a virus and preventing it from replicating. LY-CoV555 binds to a particular protein, called a spike protein, which SARS-CoV-2, the virus that causes COVID-19, needs in order to enter human cells and replicate. By preventing the virus from replicating, the antibody slows down the viral process, allowing the patient's own immune system time to kick into gear.

"What we're doing is preventing the virus from causing too much damage early on in the process," Chen said. "We're buying the patients time, so that their bodies can start developing their own immunity to fight the virus."

Patients in the randomized, double-blind study were given intravenous doses of either 700, 2,800 or 7,000 milligrams of the antibody, or a placebo. Investigators used a nasopharyngeal swab to test patients' viral load before administering the antibody and again at several points after administering the drug. Patients in the trial were also given a questionnaire about their subsequent symptoms and treatment.

Approximately 300 patients received the treatment (100 patients per dosage level) and approximately 150 patients received the placebo. Of the three dosage levels, the 2,800-milligram dosage was shown to be effective in reducing viral load. By day 11, viral load was substantially diminished for most patients, including those in the placebo arm. Further studies will be needed to validate these results, according to the investigators.

"The publication of these data in a peer-reviewed journal adds to the growing body of evidence for the potential utility for neutralizing antibodies as therapeutics for people recently diagnosed with mild to moderate COVID-19, particularly high-risk patients," said Ajay Nirula, MD, PhD, vice president of immunology at Eli Lilly and Company and co-first author of the study. "These data show LY-CoV555 may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in outpatients."

At day 29, hospitalization rates were only 1.6% in the antibody-treated group, compared with 6.3% in the group that received the placebo.

Importantly, the reduction in hospitalizations was seen across all demographic groups, including those in high-risk categories: adults older than 65 and those with a high body mass index (greater than 35). For high-risk patients, hospitalization rates were 4.2% in patients treated with the antibody, compared with 14.6% in placebo-treated patients. The safety profile of patients treated with LY-CoV555 was similar to that of placebo-treated patients.

"We know that COVID-19 is especially hard on the elderly, the obese and people with certain pre-existing health conditions," Chen said. "Antibody treatments like this may have the most benefits for people in these higher-risk categories."
The corresponding author of the new study was Daniel M. Skovronsky, MD, PhD, from Eli Lilly and Company. The other co-first author was Ajay Nirula, MD, PhD, also from Eli Lilly and Company. The research involved investigators from a total of 11 institutions and companies.

Funding: This trial was funded by Eli Lilly and Company.

Read more on the Cedars-Sinai Blog: A Positive Outcome: Donating Plasma After COVID-19

Cedars-Sinai Medical Center

Related Placebo Articles from Brightsurf:

Effect of fluvoxamine vs placebo on clinical deterioration in outpatients with symptomatic COVID-19
This randomized trial compares the effects of fluvoxamine, a selective serotonin reuptake inhibitor with immunomodulatory effects, versus placebo on a composite of dyspnea or pneumonia and oxygen desaturation among adult outpatients with polymerase chain reaction-confirmed mild COVID-19 illness.

Hydroxychloroquine no more effective than placebo in preventing COVID-19
Clinical trial with COVID-19 testing of participants shows health care workers in contact with coronavirus patients who took hydroxychloroquine each day did not reduce their rate of infection.

Compared to placebo, vitamin D has no benefit for severe asthma attacks
Contrary to earlier observational results, vitamin D supplements do not prevent severe asthma attacks in at-risk children, according to the first placebo-controlled clinical trial to test this relationship.

UMN trial shows hydroxychloroquine has no benefit over placebo in preventing COVID-19
Today, University of Minnesota Medical School researchers published the results from the first randomized clinical trial testing hydroxychloroquine for the post-exposure prevention of COVID-19.

The placebo effect and psychedelic drugs: tripping on nothing?
A new study from McGill suggests that, in the right context, some people may experience psychedelic-like effects from placebos alone.

Methotrexate reduces joint damage progression over placebo in erosive hand OA
According to new research findings presented at the 2019 ACR/ARP Annual Meeting, methotrexate did not demonstrate superior efficacy over placebo for pain relief and function evolution at three and 12 months in patients with erosive hand osteoarthritis, but did significantly reduce the progression of joint damage over placebo and seems to facilitate bone remodeling in these patients.

Botulinum toxin reduces chronic migraine attacks, compared to placebo
A growing body of evidence supports the effectiveness of botulinum toxin injections in reducing the frequency of chronic migraine headaches, concludes an updated review and analysis in the January issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

Opioids vs. placebo, nonopioid alternatives for chronic noncancer pain
An estimated 50 million adults in the United States were living with chronic noncancer pain in 2016 and many of them were prescribed opioid medications, even though a clinical benefit is uncertain.

Probiotic no better than placebo for acute gastroenteritis in children
While probiotics are often used to treat acute gastroenteritis (also known as infectious diarrhea) in children, the latest evidence shows no significant differences in outcomes, compared to a placebo.

Most common shoulder operation is no more beneficial than placebo surgery
In a landmark study published this week in the BMJ, Finnish researchers show that one of the most common surgical procedures in the Western world is probably unnecessary.

Read More: Placebo News and Placebo Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to