Mayo Clinic and collaborators have reported safety data on the first 5,000 hospitalized patients transfused with investigational convalescent plasma as part of the Food and Drug Administration’s national Expanded Access Program (EAP) for COVID-19. The early indicators suggest experimental convalescent plasma is safe in treating severely ill patients. At this time, convalescent plasma is the only antibody-based therapy available for COVID-19.
The report assessed the first seven days following transfusion of 5,000 patients hospitalized with severe or life-threatening COVID-19, or who were deemed at high risk of progressing to severe or life-threatening status. The research protocol defines severe or life-threatening as dyspnea, decreased blood oxygen saturation, respiratory failure, septic shock, and multiple organ dysfunction or failure. Sixty-six percent of the patients were in an ICU, and nearly 20% carried the diagnosis of multi-organ dysfunction or failure. Importantly, the reports of serious adverse events related to transfusion of the plasma were less than 1%.
Patients received plasma between April 3 and May 3. The seven-day incidence of mortality was 14.9%. The researchers note that while the study was not designed to evaluate the efficacy of convalescent plasma, a seven-day incidence of mortality of 14.9% in this number of patients indicates "no signal of toxicity beyond what is expected in plasma use in severely ill patients." Their next steps are to collect and review more safety data and continue studies to determine efficacy of the intervention. Read more.
The FDA granted Emergency Use Authorization to Eko, a digital health company, for the heart screening algorithm developed by Mayo Clinic. The AI-driven algorithm can detect weak heart pump, which is commonly detected by echocardiogram, a test that is not normally conducted during a physical exam, requires specially trained technicians to record, and requires prolonged contact with the patient.
"Given the danger COVID-19 poses to patients with a weak heart pump, it’s important that we rapidly identify these individuals early and monitor them closely. By embedding the heart failure screening AI into a quick, widely available, and safe test using existing medical devices, we can detect heart failure early and start appropriate treatments," said Dr. Paul Friedman, Chair of the Department of Cardiovascular Medicine, Mayo Clinic. "Additionally, for people with COVID-19, we may be able to identify when the virus causes the development of a weak heart pump quickly, safely, and easily using these AI tools."
Dr. Friedman led the team who developed the algorithm that was licensed to Eko.
The algorithm was first announced in a landmark publication in Nature Medicine in January 2019, describing for the first time the technology that permits a point of care ECG device combined with an AI algorithm to identify a low ejection fraction in patients.
The Society of Critical Care Medicine (SCCM) and Mayo Clinic have partnered to launch the first global COVID-19 registry that tracks ICU and hospital care patterns in near real-time. Created by SCCM’s Discovery, the Critical Care Research Network, the Viral Infection and Respiratory Illness Universal Study (VIRUS) will reveal practice variations and provide a rich database for research into effective treatments and care.
The registry, which is growing daily, features a dashboard of data based on more than 3,400 patients from 110 healthcare sites in eight countries. Updated regularly, the dashboard tracks data on trends such as mechanical ventilation duration, ICU length of stay, ICU discharge details and the type of medical support patients receive, as well as patient demographics: gender, age and race.
"The COVID-19 pandemic has introduced unprecedented challenges to healthcare systems worldwide, but we live in a more connected world and we must work together and learn from each other’s experiences to help reduce the severity of the impact," said Rahul Kashyap, M.B.B.S., MBA, Mayo Clinic researcher and principal investigator of the VIRUS COVID-19 Registry. "This dissemination of aggregated knowledge shared in a single database in a timely manner will be essential for comparative effectiveness studies. It will be a game changer." Read more.
Read more stories about advances in individualized medicine.
Register to get weekly updates from the Mayo Clinic Center for Individualized Medicine blog.