20/11/2020, 08h12, Photo: Reproduction.
A drug for the treatment of rheumatic diseases, tocilizumab, can help the recovery of severe covid-19 patients who need support to breathe, according to a preliminary study and not yet published in specialized journals. According to the researchers at Imperial College London, the decision to release the data before the publication of a peer-reviewed article was due to the clinical implications of the result obtained. (read more below)
Preliminary data, however, which includes the medical records of 303 patients, was assessed by a Data and Safety Monitoring Committee, composed of independent scientists, explains Anthony Gordon, the study’s lead author. According to Gordon, the participants were randomly divided to receive different modulators of the immune system: tocilizumab, sarilumab, anakinra or interferon. One party did not use any medication of this class, which aims to prevent the organism from triggering an exaggerated response to the virus, the so-called “cytokine storm”, linked to organ damage and failure.
According to the preliminary study, patients who received tocilizumab, prescribed to treat, for example, rheumatoid arthritis, were more likely to improve than those who did not receive the immune modulator. The comparison was based on a combination of factors, such as use of support for vital organs, including respirator, and discharge and survival rates. Although the data regarding the exact contribution of the drug to the participants’ recovery has not yet been analyzed, the degree of statistical certainty is high: there is a 99.75% probability that tocilizumab is a better approach, considering who has not received any modulation. immunological.
“These initial findings show that treatment with this immunomodulatory drug is effective for critically ill covid-19 patients in intensive care units (ICUs). When we have the results available to all participants, we hope that our findings will provide doctors with clear guidance for improving the prognosis of these most sick patients, ”says Anthony Gordon. In the coming months, the researchers hope to publish this information, in addition to comparing the effectiveness of the different modulators.
The analysis of tocilizumab and other immune system modulators is part of a major effort to study drugs already on the market in the treatment of people with severe or moderate covid. The Remap-CAP, coordinated by English scientists, started in March and randomly divides patients into different combinations of treatments, allowing to analyze the effectiveness of different therapies for Sars-CoV-2, including antivirals and drugs that modulate the immune response. In total, more than 2,000 patients in 15 countries, including Brazil, were enrolled in around 260 hospitals worldwide.
The evaluation revealed that an antiviral drug, lopinavir / ritonavir, is ineffective and offers no additional benefit for patients with severe covid-19 compared to those who did not receive the drug. The probability of this substance not having a positive effect for people hospitalized in ICUs was 99.9%.
Remap-CAP was also responsible for identifying, in September, that dexamethasone, a type of corticoid, reduces the mortality of critically ill patients. “This is an absolutely incredible result”, commented, in a note, Lennie Derde, consultant in intensive medicine at the University Medical Center in Utrecht and president of the Remap-CAP Immunomodulation Domain Specific Working Group. “Having a second effective therapy for critically ill patients a few months after the start of the pandemic is unprecedented. The specific targeting of the immune response is theoretically attractive and we have now shown that it works. ”
The professor of Pharmacoepidemiology at the Faculty of Hygiene and Tropical Medicine in London, Stephen Evans, recommends, however, caution with the first results on tocilizumab. “A recent study published in the New England Journal of Medicine with hospitalized patients did not find a survival benefit among those who took the drug. They were less seriously ill than those reported in the Remap-CAP study, ”he says. “However, it is possible that different medications work better at different times during the illness. Still, I think these results need to be treated with caution at this early stage. ”
WHO does not recommend using remdesivir
The antiviral drug remdesivir should not be indicated for patients hospitalized with covid-19, regardless of how seriously ill they are, because there is currently no evidence that it improves survival or the need for mechanical ventilation, the Policy Development Group said. World Health Organization (WHO) in an article published in the British Medical Journal. The recommendation is based on a new review of evidence comparing the effects of various treatments with various drugs and includes data from four international randomized controlled trials involving more than 7,000 patients hospitalized for covid-19.
Oxford vaccine is safe for the elderly
The day after Pfizer released the information that the US vaccine is effective in the elderly, the University of Oxford published initial phase 2 results in the Lancet, including 560 adults, 240 of whom were over 70 years old. The research attests that the immunizing agent is safe and triggers an immune response, including in the elderly, with the production of antibodies and T cells. However, this is not an efficacy study, when comparing the percentage of vaccinated participants and the placebo group. who have been infected with Sars-CoV-2.
Developed in partnership with the European laboratory AstraZeneca, the immunizer is currently in phase three of tests, even conducted in Brazil. So far, no drugmaker has published data from that stage – when looking at the effectiveness of a vaccine. Pfizer, Moderna and the Russian government released phase 3 results, but only in press releases. The University of Oxford has announced that, until Christmas, it will publish its own in a peer-reviewed scientific journal.
In the article published yesterday, the researchers reported that the vaccine, called ChAdOx1 nCoV-19, showed similar safety and immunogenicity results in the age groups 18 to 55 years and over 56. In both age groups, T cells were produced 14 days after the first dose, and antibody response within 28 days after booster immunization.
“Immunological responses to vaccines are often diminished in the elderly because the immune system gradually deteriorates with age, which also makes the elderly more susceptible to infections. As a result, it is crucial that covid-19 vaccines be tested in this group, which is also a priority group for immunization, ”said the study’s lead author, Andrew Pollard, of the University of Oxford.
The study by the English institution is the fifth clinical trial that reports tests of some type of vaccine for covid-19 in the elderly. While that of North American Modern showed a similar response to that of the British, that of Pfizer / BioNTech, that of Chinese CanSino and that of SinoPharm, also from China, had a lower immune response in older participants, compared to volunteers with 18 to 55 years. However, the Oxford researchers pointed out, at an online press conference, that it is difficult to compare results from different studies, since each has its own methodology. The scientists also pointed out that none of the participants, including the elderly, had comorbidities when recruited.
The most common adverse reactions were pain and tenderness at the injection site, headache and muscle pain, and fatigue. According to the article, 13 serious adverse effects were observed, but none were related to ChAdOx1 nCoV-19. These results need to be confirmed by phase 3 tests, the authors pointed out.
“Immunosensence – literally, the aging of the immune system in elderly people – can lead to less effective vaccines. This is especially important because covid has a much higher lethality in the elderly,” notes Gillies O’Bryan-Tear, president of the Faculty of Pharmaceutical Medicine in the UK, which is not involved in the study. “But, in an encouraging way, the immune responses in older patients were indistinguishable from those of younger ones. This suggests, but does not prove, that protection against the disease will be similar in the elderly and young. ”
Source: Correio Braziliense
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