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Roche/Regeneron antibody REGEN-COV reduced 70% COVID-19 death risks!
Roche/Regeneron antibody REGEN-COV reduced 70% COVID-19 death risks! Roche/Regeneron antibody cocktail REGEN-COV treatment of ambulatory (outpatient) patients: the risk of hospitalization/death is reduced by 70%!
Recently, Roche partner Regeneron announced the detailed results of the key Phase 3 trial of antibody cocktail therapy REGEN-COV (casirivimab and imdevimab) at the 2021 American Thoracic Society International Conference (ATS 2021).
Data show that, compared with placebo, REGEN-COV significantly reduces the risk of hospitalization or death of COVID-19 outpatients (outpatients) by 70%, shortens the time to symptom resolution by 4 days, and also significantly reduces the viral load.
In this study, the efficacy of the two doses (1200mg and 2400mg) was similar. Currently, the US FDA is reviewing an application for an emergency use authorization (EUA) to increase the 1200 mg dose.
Julie Philley, the investigator of the trial and the chair of internal medicine at the University of Texas Health Science Center, said: “Despite the continuous increase in COVID-19 vaccination rates, many people are still diagnosed with COVID-19.
People who are at higher risk of severe COVID-19 disease due to underlying diseases such as asthma or chronic obstructive pulmonary disease will be able to benefit from REGEN-COV. This phase 3 trial shows that REGEN-COV can help patients avoid hospitalization and even death, while speeding up recovery time.
These results add to the growing body of clinical evidence, real-world experience, and strong recommendations from the National Institutes of Health (NIH) COVID-19 treatment guidelines, all of which together emphasize the urgent need to ensure that all suitable patients receive treatment. “
This phase 3, randomized, double-blind, placebo-controlled trial evaluated REGEN-COV in 4567 high-risk COVID-19 outpatients. Two doses of REGEN-COV (1200mg, 2400mg) were studied in the trial. Among them, the 2400mg dose has been approved by the US FDA, and the 1200mg dose is under review. All patients evaluated for efficacy have at least one risk factor for severe COVID-19, such as chronic lung disease (including asthma), obesity, cardiovascular disease, or age ≥50 years.
In March 2021, Roche and Regeneron announced the positive top-line results of the trial, showing that REGEN-COV reached the primary endpoint and all secondary endpoints, and the efficacy of the two doses was similar. The detailed data released at the meeting showed that patients receiving 1200mg or 2400mg REGEN-COV treatment experienced:
- Compared with placebo, by day 29, the risk of hospitalization or death was reduced by 70% (p=0.0024) and 71% (p<0.0001).
- The time to resolve symptoms was shortened by 4 days, the median of the REGEN-COV 2 groups was 10 days, and the median of the placebo group was 14 days.
- Compared with placebo, the viral load was significantly reduced by 0.71 log10 copies/mL and 0.86 log10 copies/mL within 7 days (both p<0.0001).
- As of the 169th day, 5531 patients had been assessed for safety, and the safety profile was consistent with the previously reported data. Serious adverse events (SAEs) were mainly related to COVID-19 and occurred in 1.1% of patients in the 1200 mg group, 1.3% in the 2400 mg group, and 4.0% in the placebo group. There was 1 death in the 1200 mg group (n=827), 1 death in the 2400 mg group (n=1849), and 5 deaths in the placebo group (n=1843).
REGEN-COV is a cocktail therapy consisting of two kinds of antibodies, which are directed against two independent and non-overlapping sites in the SARS-CoV-2 spike protein receptor binding region. They have a synergistic effect and can reduce The risk of virus mutation and escape. Data from non-human primates show that REGEN-COV can prevent SARS-CoV-2 infection and treat infected animals by accelerating virus clearance.
REGEN-COV was developed to treat and prevent COVID-19 infection. In August 2020, Roche and Regeneron reached a strategic cooperation to develop, manufacture and distribute REGEN-COV to all parts of the world. The drug is expected to provide a much-needed treatment option for those infected with COVID-19 symptoms, and has the potential to be used in Prevent infection in high-risk populations who have been exposed to the virus, thereby slowing the spread of the global pandemic.
In November 2020, the U.S. FDA granted REGEN-COV Emergency Use Authorization (EUA) for the treatment of high-risk populations who have recently been diagnosed with mild to moderate COVID-19, specifically: new coronavirus (SARS-CoV-2) direct Children and adults with a positive test result and a high risk of developing severe COVID-19 and/or hospitalization, age ≥12 years old, and weight ≥40 kg. The US NIH COVID-19 treatment guidelines strongly recommend the use of REGEN-COV in these patients. In addition, research has shown that REGEN-COV retains its effectiveness against the main variant of COVID-19 that is feared to be epidemic in the United States in vitro. REGEN-COV is administered intravenously (IV) and the infusion time is as short as 20 minutes.
In the European Union, in January 2021, the European Medicines Agency (EMA) Committee for Medicines for Human Use (CHMP) issued a scientific opinion in accordance with Article 5(3) of Regulation No. 726/2004 to support the use of REGEN-COV as a diagnosis A treatment option for COVID-19 patients who do not need supplemental oxygen and are at high risk of infection to progress to severe COVID-19. Before the official authorization is issued, the EU member states can consider the scientific opinions of the CHMP when making decisions on the use of medicines at the national level. The review under Article 5(3) is conducted separately, but at the same time as the REGEN-COV rolling review currently underway by EMA.
Currently, REGEN-COV will continue to be evaluated in outpatient (symptomatic and asymptomatic infections), prevention, and certain hospitalized COVID-19 patients. In April 2021, Regeneron and Roche announced the preliminary positive results of a phase 3 study (REGN-COV 206), which evaluated REGEN-COV in the home contact of people infected with the new coronavirus (SARS-COV-2) The ability to reduce the risk and burden of COVID-19 infection among people.
The results showed that the study reached the primary endpoint and key secondary endpoints. The data showed that in individuals who were not infected at the time of entry, subcutaneous injection of REGEN-COV reduced the risk of symptomatic infection by 81%. In addition, individuals who received REGEN-COV treatment but still experienced symptomatic infections disappeared within 1 week on average, compared to 3 weeks for placebo. During the study, no new or serious safety signals were observed
(source:internet, reference only)