Preliminary results released by a British biotech firm show that aerosol-based drug treatment could drastically reduce the number of new coronavirus patients dying from the disease or requiring intensive care.
In a randomised trial of 100 patients admitted to hospital with COVID-19, those who received an inhaled formula of the protein interferon beta were at 79 percent lower risk of developing the severe disease compared to those who received a placebo.
They were also more than twice as likely to make a full recovery compared with the control group.
Nigeria however on Wednesday logged eight fresh COVID-19 deaths, thus raising the national death toll to 813. The country also recorded 543 new confirmed cases of the killer virus.
Nigeria Centre for Disease Control (NCDC) says ‘’till date, 38344 cases have been confirmed, 15815 cases have been discharged and 813 deaths have been recorded in 36 states and the Federal Capital Territory, Abuja.’’
Of the 543 new cases reported from 15 states, Lagos recorded 180 cases, followed by Abuja’s 86, Kaduna 56, Edo 47, Ondo 37, Kwara 35, Ogun 19, Rivers 19, Kano 17, Ebonyi 16, Enugu 16, Delta seven, Bayelsa four, Bauchi three, and Abia one.
Interestingly, the firm behind the treatment, known as SNG001, said the preliminary results suggested: “a major breakthrough” in the pandemic.
CEO of Synairgen, Richard Marsden, says “we are all delighted with the trial results announced today, which showed that SNG001 greatly reduced the number of hospitalised COVID-19 patients who progressed from requiring oxygen to requiring ventilation.”
The results published Monday have not yet been peer-reviewed and the sample size is relatively small. But if confirmed the treatment could revolutionise the way COVID-19 is dealt with in hospitals.
Interferon beta is a naturally occurring protein, commonly used to treat multiple sclerosis.
It forms part of the body’s natural fight against infection, and the novel coronavirus suppresses its production in an attempt to evade an immune response
Delivering the protein directly into the lungs of patients is designed to trigger a robust immune response to the virus, even in patients whose immune system is already weakened by infection.
Professor of respiratory medicine at the University of Southampton, Tom Wilkinson, says “the results confirm our belief that interferon-beta… has huge potential as an inhaled drug to be able to restore the lung’s immune response.”
He said the trial showed SNG001 was effective in “enhancing protection, accelerating recover and countering the impact of SARS-CoV-2 virus.”
There are currently a number of treatments available for patients hospitalised with COVID-19.
Last month a Britain-based team of researchers lead by the University of Oxford announced they had successfully reduced the risk of death among seriously ill patients by administering the commonly available steroid dexamethasone.
Several countries have also issued the emergency authorisation for treatment with anti-viral remdesivir.
However, Nigeria on Wednesday recorded fresh COVID-19 deaths which immediately raised the national death toll to
The surging cases and deaths in Nigeria are happening as United States’ University of California (UC) is currently leading efforts to test a new antibody cocktail (REGN-COV2) as a prevention and treatment for COVID-19.
Chairman of Internal Medicine and specialist in pulmonary and critical care with the university’s Davis Health, Timothy Albertson, is leading the effort.
UC Davis Health is however concerned with improving lives and transforming health care by providing excellent patient care, conducting groundbreaking research, fostering innovative, interprofessional education, and creating dynamic, productive partnerships with the community.
It is a major driver of economic prosperity in the Sacramento region and Northern California. According to a 2010 study, it generates more than $3.4 billion in annual economic output and more than 20,000 jobs.
For every employee or dollar of output directly supported by UC Davis Health’s operations, the Northern California economy gains an additional 1.1 jobs or $1.10 of output, respectively.
Albertson was awarded a grant to run the clinical trial at UC Davis Health. The grant comes from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
The clinical trial is sponsored by Regeneron Pharmaceuticals. It is an adaptive phase I, II and III randomized, double-blinded, placebo-controlled study. It seeks to evaluate the efficacy and safety of REGN-COV2 (a combination of REGN10933+REGN10987 antibodies) in hospitalized adult patients with COVID-19. It builds on encouraging findings from a set of studies that showed the neutralizing impact of REGN10933 and REGN10987.
“We are very excited to test this antibody combination as a possible treatment to COVID-19,” Albertson said. “We are all up and running on this clinical trial and will start patient recruitment soon.”
At this time, there is no approved treatment that specifically targets SARS-CoV-2.
Disabling the SARS-CoV-2 Spike protein
The spike proteins on the outer envelope of coronaviruses allow entry and bind to the host cells. They appear to be central to why SARS-CoV-2 is so infectious. Previous studies have found that the viral infectivity of coronaviruses such as SARS-CoV and MERS-CoV was reduced when neutralizing antibodies were used against spike protein, blocking the host cell entry.
Currently, there are multiple efforts to develop antibodies that target the spike protein. Regeneron is developing and testing fully human, neutralizing monoclonal antibodies (mAbs) directed against the spike protein of SARS-CoV-2 for the treatment and prevention of COVID-19.
Regeneron antibody cocktail as potential COVID-19 treatment
To this end, Regeneron developed the REGN-COV2 antibodies to bind to the SARS-CoV-2 spike protein and block its interaction with the host receptor, which is expected to neutralize the virus.
The clinical trial will test the safety, tolerability and efficacy of REGN-COV2 as a promising therapeutic strategy to reduce SARS-CoV-2 viral shedding and COVID-19 disease progression.
In the meantime, the Annals of the Rheumatic Diseases, the journal of the European League Against Rheumatism, EULAR, has published findings of an observational study on the treatment of patients with COVID-19-associated Cytokine storm syndrome (CSS).
The study demonstrates that a treatment strategy combining intensive immunosuppression (using glucocorticoids and an IL-6 inhibitor) as well as close monitoring dramatically improves patient outcomes when compared to supportive care only.
The study shows that this experimental treatment protocol can reduce hospital mortality by 65%.
Moreover, it shows that clinically relevant improvement of respiratory status is 79% more likely than with standard of care alone and can be accelerated by a median of seven days. Additionally, the need for mechanical ventilation during admission could be reduced by 71%.
Poor outcomes in people with COVID-19 is associated with a state of systemic hyper inflammation reminiscent of a cytokine storm syndrome (CSS) that has been reported previously as a rare and potentially lethal complication of various infections, malignancies and autoimmune diseases.
Immune hyperreactivity is an important complication of COVID-19 in up to 25% of affected patients, often responsible for a fatal outcome.
The study was conducted at Zuyderland Medical Center (ZMC) in the Netherlands, at which a 40% mortality rate amongst critically ill patients with COVID-19 associated CCS was observed under supportive care “only” treatment by the end of March 2020.
It details the results of 86 patients with COVID-associated-CSS who were treated with glucocorticoids (and in some cases an IL-6 inhibitor) from the start of April, 2020. These have been compared with the patient outcomes of a historical control group of 86 patients, matched for sex and age, who received supportive care ‘only’.
Patients eligible to the retrospectively assembled control group had to be admitted between March 7 and March 31, 2020, and should have signs of CSS.
Study author Professor Robert B.M. Landewé states, “our study shows that the sickest COVID-19 patients, namely those with signs of cytokine storm, had a dramatic beneficial effect on glucocorticoids. This appears to be one of the contrasting points of our studies compared with others, namely that we have only treated cases with signs of cytokine storm, and not all COVID19-patients.”
There are two steps for the treatment protocol: Treatment with glucocorticoids for between five and seven days, and secondly, where necessary, the escalation of immunosuppressive treatment with an IL-6 inhibitor between day two and day five with the possibility of an extension.
The study also highlights the importance of combining intensive immunosuppression with early intervention and close monitoring by a multidisciplinary team.
Until now, information about the immunosuppressive treatment of COVID-19-associated CSS has only been anecdotal. Several experts, including the World Health Organisation, have warned against treating critically ill patients with a COVID-19 infection with glucocorticoids; advice which could have potentially serious implications for many patients.
While the study’s authors recognize that these results require a confirmation from a randomized controlled trial (RCT), they believe that the outcomes are robust.
They also believe that the risk profile of such a short course of glucocorticoids for treatment of CSS needs to be separated from their pre-existing chronic use for conditions like rheumatic and musculoskeletal diseases.
The study’s recommendations are that CSS should be recognized and considered as a treatable complication of COVID-19 and that immunosuppressive treatment should be started timely. Additionally, that short term treatment with high-dose glucocorticoids is a convenient choice since they are safe, widely available and inexpensive.
Rheumatologists were involved in this study because of their expertise in immunosuppressive treatment, as advised in recent EULAR Recommendations