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FDA approved mesenchymal stem cell (MSC) treatments as compassionate use in the very sickest COVID-19 patients.

April 22nd, 2020 | Real World Evidence

A pilot study in China in which seven COVID-19 patients received intravenous infusions of donor mesenchymal stem cells (MSC) indicates that the intervention was safe, and that the approach may improve infection outcomes was reported in Aging and Disease last month. We understand that it is only a small number of cases, and studies in […]

Saliva Test for COVID-19 reduces health care professional risk of infection

April 15th, 2020 | Real World Evidence

Saliva Test for COVID-19 Approved for Emergency Use by FDA on 13 April 2020. Saliva testing will help with the global shortage of swabs, increase possibility of people testing, and reduce risk to collect samples by health care professionals. The saliva-based test requires saliva collection by subject spitting several times in a given plastic tube. […]

COVID-19 Global Pandemic disruption in RARE DISEASE clinical research

April 14th, 2020 | Real World Evidence

The COVID19 has taken the world by a stranglehold and the outbreak is causing significant disruptions in clinical research which is facing significant challenges. The process for conducting conventional clinical trials become difficult and risky at a time when the public is advised to shelter at home and healthcare facilities become overwhelmed with caring for […]

Protective Antibodies to COVID-19

April 1st, 2020 | Real World Evidence

Whether people develop immunity to COVID19 after being infected once is a pressing question. It’s of particular interest to several research developing plasma therapies, whereby antibody-containing blood plasma is extracted from recovered patients and administered to patients to help them fight off the infection. In rhesus macaques, a longitudinal tracking of re-exposure after the disappeared […]

COVID19 Infects the Nervous System

March 27th, 2020 | Real World Evidence

The fact that COVID-19 patients have lost their sense of smell or taste is interesting because, if the virus infects the nose, it would use the exact same neurons as in the mouse studies to enter the brain. SARS‐CoV2 causes epidemic pneumonia characterized by acute respiratory distress. This novel coronavirus is similar to SARS‐CoV in […]

Clinical Studies: COVID-19 Gut Infection in Pediatrics

March 26th, 2020 | Real World Evidence

Several studies were conducted to evaluate the presence of COVID-19 in the GI track and eliminated with stools. The first case report in the USA of COVID-19 was published in The New England journal of medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2001191). The report showed, as early as day seven of clinical symptoms, elimination of COVID-19 in the stools of […]

Clinical Trial of COVID-19 Vaccine Begins

March 18th, 2020 | Real World Evidence

The first participant in a clinical safety trial for a COVID-19 vaccine conducted by the Kaiser Permanente Washington Health Research Institute in Seattle was given an experimental dose on March 16, reports the Associated Press. Testing will begin with 45 young, healthy volunteers with different doses of shots co-developed by NIH and Moderna INC. Inovio […]

How soon can a vaccine can be tested in Clinical trials? #clinicaltrials

March 13th, 2020 | Real World Evidence

How do viral genomes’ sequences from swabs taken from infected patients help you build a family tree of the virus? Random mutations in the SARS-CoV-2 pathogen’s genome help researchers track the spread and transmission of COVID-19, the disease it causes. Source: News & Opinion Articles | The Scientist Magazine®

How to shape clinical plan and study design to test how microbiome shapes immunity.

February 27th, 2020 | Real World Evidence

The gut microbiome serves many useful functions in the body, but it can also rev up the immune system in harmful ways. Zit has been pustulated that Diet can influence the microbiome and the mucosal immune response. In the paper: “Diet modulates colonic T cell responses by regulating the expression of a Bacteroides thetaiotaomicron antigen,” Sci Immunol, 4:eaau9079, […]

Innovative therapies clinical plan requires understanding Why Immune Cells Extrude Webs of DNA and Protein

February 25th, 2020 | Real World Evidence

Today, it is widely accepted that NETs have both a protective and a pathological impact on the host. When neutrophils encounter pathogens, not only engage in phagocytosis and degranulation, they also release neutrophil extracellular traps (NETs) In CANCER, NET-associated proteins lead to reawakening of dormant cancer cells and convert them to proliferating metastatic cells. In […]