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A single injection of the monoclonal antibody cocktails Casilibimab and Imdebimab (REGEN-COV) within 72 hours of the family being diagnosed with SARS-CoV-2 results in 100% COVID-19 disease and 100% high SARS- It was prevented. Reduces CoV-2 viral load and asymptomatic infection length to one week.
“Great news,” said Rajesh Gandhi, MD, an infectious disease specialist at Massachusetts General Hospital and Harvard Medical School. He has been treating seriously ill people with COVID-19 since the pandemic began in Boston a year ago. COVID-19 “For individuals who are not vaccinated for some reason, who refuse to vaccinate, or who have not yet been vaccinated, it is really proof that antibodies can prevent the disease.”
Gandhi is the chair HIV He is a medical association and a member of the COVID-19 Treatment Guidelines Committee of both the Infectious Diseases Society of America and the National Institutes of Health, but he was speaking for himself.
The data were presented at the 2021 Annual Meeting of the Virtual Conference on Retroviruses and Opportunistic Infections. Still, the striking results mean that SARS-CoV-2 infection is based on studies with very few overall, and the results have not reached statistical significance.
Data are previous details of Regeneron Press release, This suggested that the antibody provides protection during the COVID-19 treatment trial. Both Regeneron and Eli Lilly, Presented preventive data Regarding the antibody gamlanivimab, we are discussing an emergency use authorization for the antibody as a preventive measure with the US Food and Drug Administration.
REGEN-COV data represent the first 409 SARS-CoV-2 negative people enrolled in an ongoing study testing both the therapeutic and prophylactic effects of a combination of kacilibimab and imdebimab. Another division of the study not discussed in these data includes a family of 409 SARS-CoV-2 negative participants who were tested positive for the virus at baseline.
Overall, the median age was 44 years, with 54.5% of participants being female, 48.9% being Latin, and 12.6% being black. People taking the active ingredient are slightly more likely to be female and Latino, and slightly less likely to be black. This is because blacks have as many SARS-CoV-2 cases as whites, 2.9 times more likely to be hospitalized The chance of dying from the virus is 1.9 times higher.
All participants in this study lived with people who were positive for SARS-CoV-2.Their average body mass index was 29.4 kg / m2Just below the threshold of obesity.. Between the arms, 10% to 13% of participants had diabetes, 14% to 17% were 55 years or older, and there were markers of potentially adverse consequences when infected: cardiovascular disease, High blood pressure, Or Chronic obstructive pulmonary disease..
Participants were randomized 1: 1 to receive a single 1.2 g injection of placebo or casilibimab and imdebimab. Then, for 28 days, researchers obtained weekly quantitative PCR data from the nasopharynx, oropharynx, nose, and saliva, and followed up for COVID-19 symptoms for 29 days. After 28 days, participants were followed for 7 months for long-term persistence of the antibody and subsequent development of SARS-CoV-2 infection.
At the end of 28 days, the overall infection rate with SARS-CoV-2 was very low (7.85%), combining the placebo and treatment groups in the study. However, it made it difficult to clearly prove the therapeutic effect.
“I was surprised that the number of infections was lower than expected,” said Regeneron’s Doctor of Medicine, Megan O’Brien. Medscape Medical News.. “When we designed the trial in the summer, all the information about home infections at the time seemed to be from China, and that percentage seemed to be about 15%. Therefore, someone in your home COVID- If you have 19, you have a 15% chance. Others will get it. “
If so, the fact that people who received Casilibimab and Imdebimab developed SARS-CoV-2 in half of those who received placebo provides 50% protection from SARS-CoV-2 acquisition. It was definitive proof that I did. However, since the summer, data on home infections are very different. As it was, the overall infection rate of 7.85% and the infection rate of 10.3% in the placebo group were that there were not enough people in the study because the 50% reduction was statistically significant. Meaned.
Nevertheless, the results tended to be important and were even more impressive when the researchers focused on the results: 10 (5.3%) of participants who received Kasilibimab and Imdebimab received SARS-CoV-2. Although acquired, no one developed symptoms of COVID-19, and none had SARS-CoV-2 viral load above 10 in the nose.Four Copy number / mL — Indicates a high viral load and may have a high infection rate to others.
This is the origin of 100% claim. The antibody prevented symptomatological SARS-CoV-2 100% and viral load 100%.
“All reductions in infections within the REGEN-COV group were asymptomatic, with lower peak virus levels and shorter periods of viral shedding,” O’Brien said in a pre-recorded presentation. “Placebo infections showed 100-fold higher peak viral load. REGEN-COV infections lasted about 1 week, while 40% of placebo infections lasted 3-4 weeks.”
In addition, the data show that when people in the placebo group acquired SARS-CoV-2, the virus persisted for 44 weeks, of which the viral load exceeded 10 in 22 weeks.Four Copy / mL. In contrast, in the antibody group, SARS-CoV-2 was only detected for 9 weeks and did not reach such a high rate of viral shedding.
In addition, none of the participants were hospitalized with COVID-19 in the 28-day aggressive treatment group, but one in the placebo group was hospitalized with COVID-19 symptoms approximately 12 weeks after a negative test. Another person in the placebo group who tested positive for SARS-CoV-2 had a heart attack 6 weeks after the start of the study.
None of the participants experienced a serious reaction to the following shots: Anaphylaxis Or seizures, and 5 people in each arm developed adverse events due to other treatments. Injection site reactions were common in people who received almost twice as much active ingredient as those who received placebo, but both were low (2.6% vs. 1.4%).
The fact that the results were not statistically significant did not diminish much enthusiasm for the results among the attendees.
Chloe Orkin (MBBCH), a professor of infectious diseases at the Blizzard Institute at Queen Mary University of London, tweeted, “The excellent results of PEP’s REGEN-COVmAb in domestic contact.”
Dr. Peter Hunt, MD, professor of medicine at the University of California, San Francisco AIDS Research Center, said: Medscape Medical News The results were sufficient for him to say that as the vaccine was slowly deployed around the world, antibodies could change the way public health addresses the fairness of COVID-19 responses.
For example, by providing antibodies to people in prisons and camps, he said, instead of waiting weeks for the vaccine to be fully effective, it could prevent or stop the outbreak within a week.
“The primary role of these drugs is in areas where vaccination growth is slow or absent,” Hunt said. Medscape Medical News.. “For example, in low- and middle-income countries, these monoclonal antibodies are deployed during outbreaks in complex facilities (nursing homes, prisons, etc.), which can prevent many deaths.”
Conference on Retroviruses and Opportunistic Infectious Diseases (CROI) 2021 Annual Meeting: Summary 123LB. Announced March 9, 2021
Heather Boerner Pittsburgh , And can be found on Twitter @HeatherBoerner..Her book, Positive Negative: Amazing Victory Against HIV in Love, Sex, and Science, Was released in 2014.
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