BioSerenity, Leader in Healthcare as a Service (HaaS), Helps Advance Understanding of COVID-19 Neurological Impact

BioSerenity offers EEG services using remotely connected equipment enabling testing outside of traditional departments.   Hospitals in France requested BioSerenity to perform EEGs in Intensive Care Units (ICUs) during the initial surge of Covid-19 patients. The data was reviewed remotely by BioSerenity’s specialists and shared with the hospitals’ medical staff. Via these collaborations, we were one of the first to discover EEG anomalies likely associated with Covid-19. BioSerenity will provide data to help physicians diagnose over 30,000 patients suffering from neurological disorders this year.   We are excited to report our discovery to assist medical professionals in treating COVID-19 patients. 

According to Dr. Bruce Lavin, Chief Medical Officer, “This report highlights the importance of obtaining EEGs in patients with COVID-19 who present with cognitive impairment to identify possible brain injury, directly or indirectly due to the virus.” Samir Medjebar, Ph.D., GM BioSerenity France adds, “BioSerenity has demonstrated that our scale and scope of services allow us to provide 24/7 hospital assistance during a crisis and the ability to detect new EEG findings.”

Louis Maillard, Professor at Lorraine University, France, commented that “This study gives a possible explanation for the comas, delayed awakening and arousal observed in some of the most severe cases of Covid-19 infections. It shows the importance of EEG, an old but still relevant exam that can be done at the patient bedside and the only exam that allows for the functional state evaluation of the brain.”

Cell therapy weekly: FDA approves Phase I trial of cryopreserved, cord blood-derived, T-regulatory cells for COVID-19-associated ARDS

Cellenkos® Inc. (TX, USA) has announced it has received US FDA clearance to initiate a double-blinded, placebo-controlled, Phase I clinical trial to assess the safety and preliminary efficacy of CK0802 – an off-the-shelf, cord blood-derived, allogeneic T-regulatory cell product – in hospitalized patients with COVID-19-associated acute respiratory distress syndrome (ARDS).

Elizabeth Read, Chief Technology Officer at Cellenkos Inc., commented: “We appreciate FDA’s expedited review of our plans to evaluate CK0802 in critically ill, intubated patients suffering from ARDS, a deadly complication of COVID-19…In the forthcoming Phase I randomized trial, CK0802 will be assessed for both toxicity and 28-day treatment success, as co-primary outcomes.”


A cheap steroid is the first drug shown to reduce death in COVID-19 patients

After months of dire news about the spread of the novel coronavirus and a mounting global death toll, a glimmer of hope arrived today: Researchers announced that dexamethasone, a cheap, widely available corticosteroid, significantly reduced deaths of severely sick COVID-19 patients in a major clinical trial. Although full trial data have not yet been released, several outside commentators hailed the result as a “breakthrough.”

“These are really surprising, but really very convincing results,” says Martin Landray of the University of Oxford, one of the principal investigators of the Recovery trial in the United Kingdom that evaluated the steroid. If they hold up, adds Devi Sridhar, an expert on global public health at the University of Edinburgh, they could be a game-changer for critical patients, as the drugs are accessible even in lower-income countries. Dexamethasone’s effect is seemingly much stronger than that of redeliver, the only other drug so far shown to help COVID-19 patients in a randomized clinical trial. That antiviral reduced the number of days critical patients were hospitalized, but it did not clearly reduce deaths.


Convalescent Plasma Therapy Found Safe For COVID-19 Patients

The country’s first peer-reviewed study of a COVID-19 treatment that transfuses blood plasma from recovered patients into critically ill patients found about 76 percent of patients improved. Collaborators at The University of Texas at Austin (UT-Austin) developed an antibody test and selected recovered patients with the highest levels of antibody response for donation. With no adverse side effects caused by the plasma transfusion, this study concluded that convalescent plasma therapy is a safe treatment option for patients with severe COVID-19 disease.

This rapid approval granted by the FDA opened access to convalescent plasma treatment for COVID-19 patients. Additional findings during this trial revealed patient outcomes after plasma therapy were similar to recently published results of patients treated on a compassionate-use basis with the antiviral drug redeliver. The research team also concluded that any observed complications were consistent with findings reported for COVID-19 disease progression and did not result from the plasma transfusions.


Cancer Immunotherapy Tools Identify Coronavirus Vaccine Options

Cancer researchers at Children’s Hospital of Philadelphia (CHOP) have harnessed tools used for the development of cancer immunotherapies and adapted them to identify regions of the SARS-CoV-2 virus to target with a vaccine. These CHOP researchers are employing the same approach used to elicit an immune response against cancer cells to stimulate an immune response against the virus.

“In many ways, cancer behaves like a virus, so our team decided to use the tools we developed to identify unique aspects of childhood cancers that can be targeted with immunotherapies and apply those same tools to identify the right protein sequences to target in SARS-CoV-2,” said senior author John M. Maris, M.D., a pediatric oncologist in CHOP’s Cancer Center and the University of Pennsylvania. The researchers looked for regions that would stimulate a memory T-cell response that, when paired with the right B cells would drive memory B cell formation and provide lasting immunity and do so across the majority of human genomes.

“A subset of the sequences selected in our study is derived from viral regions that are very similar to other coronaviruses, and thus our approach, if successful, could lead to protection against not only SARS-CoV-2 but also other coronaviruses that might emerge in the future.”


EU unveils coronavirus vaccine strategy to accelerate the development

The European Commission (EC) has set out a number of objectives for a new European coronavirus vaccine strategy, noting that “time is of the essence”. These include ensuring the quality, safety, and efficacy of vaccines; securing swift access to vaccines for member states; and ensuring equitable access to an affordable vaccine as soon as possible. This, the EC said, would be achieved by securing the production of vaccines in the EU through advanced purchase agreements with vaccine producers using the €2.7bn Emergency Support Instrument. In return for the right to buy a specified number of vaccine doses in a given timeframe, the EU will finance part of the upfront costs faced by vaccine producers.

The strategy will also look to adapt existing regulatory frameworks around vaccines, including an accelerated procedure for authorization, flexibility in relation to labeling and packaging. There is also a proposal to provide temporary derogations from certain provisions of the GMO legislation to speed up clinical trials of Covid-19 vaccines and medicines containing genetically modified organisms.