Scientists announce breakthrough in drug to treat Covid-19

According to clinical trials in susceptible F0 patients, Regen-CoV showed good tolerability, safety, and reduced the risk of infection and death.

Regen-CoV has been shown to be effective in mild to moderate Covid-19 patients. In a study published on medRxiv on November 16, the manufacturer found that this drug also has a breakthrough effect on patients who are severely immunocompromised when infected with Covid-19.

Immunocompromised patients, especially those with B-cell deficiency or who are using immunosuppressive drugs, are not able to produce antibodies after being vaccinated with Covid-19 as strong as normal people. This makes even though vaccinated, the risk of infection, seriousness, and death in these patients is still very high. In the US, 3% of the population is immunocompromised.

A newly published study evaluates the effectiveness of a monthly dose of Regen-CoV given subcutaneously to nCoV-negative adults with normal health or chronic medical conditions.

The study is in phase 1, involving two groups of volunteers, being carried out at seven sites across the United States. Of these, one group received a placebo injection (235 people), the remaining 705 received a monthly dose of Regen-CoV. They were monitored and recorded at 7 days, 24 weeks, and 28 weeks.

Volunteers received up to 6 doses of Regen-CoV 1,200 mg or placebo over a 4-week period. Then, the authors evaluated the safety and immunogenicity of the drug.

Immunocompromised people who receive a monthly injection of Regen-CoV are likely to protect against Covid-19 for at least 6 months. (Photo: Reuters).

This is the first study to evaluate the impact of monthly doses of Regen-CoV injection. The results show that at the tested dose, the drug is safe, well tolerated and can prevent Covid-19 for at least 6 months.

Specifically, Regen-CoV reduced the risk of Covid-19 by 92.4% in clinical trials and 100% in laboratory conditions.

The production of antibodies against IgG in people who received Regen-CoV injections for 6 months was significantly reduced. The anti-IgG antibody seroconversion rate in the placebo group was 9.6% and in the Regen-CoV group it was 0%. This shows that Regen-CoV helps immunocompromised people respond better to Covid-19 treatments and vaccines.

The rate of side effects in people who received the drug was higher than in the placebo group, but the difference was not too large. The average adverse event rate was 36.5% across all 6 doses. The team claims this shows that the doses of Regen-CoV are well tolerated.

With these data, the authors say this result reinforces the safety, tolerability and effectiveness of monthly doses of Regene-CoV when administered subcutaneously.

In addition, no cases of grade 3 hypersensitivity reactions were reported. All cases of side effects were mild to moderate. The drug did not increase the incidence or severity of adverse events following Regen-CoV injection.

Regen-CoV is a mixture of monoclonal antibodies to treat and prevent Covid-19 developed by the American biotechnology company Regeneron Pharmaceuticals. The drug's formulation is based on a combination of two neutralizing monoclonal antibodies - casirivimab and imdevimab - that bind differentiated epithelium on the SARS-CoV-2 receptor-binding domain (RBD), preventing entry of virus into host cells.

On October 8, the US Food and Drug Administration (FDA) approved the use of Regen-CoV for adults and children 12 years of age and older, weighing at least 40 kg, who are at high risk. become seriously ill, hospitalized when infected with Covid-19. This is also the first therapy approved by the US as a post-exposure prophylaxis against Covid-19.