A multicenter research team led out of China and including investigators from Brigham and Women’s Hospital as well as Harvard Medical School evaluated the clincial efficacy of convalescent plasma on critically ill patients with SARS-CoV-2, the virus behind COVID-19. The predominantly China-based research first cautioned that they have found previously due to the limitations of the conditions of mass production of convalescent plasma, obtaining the investigational product had been difficult. Importantly, the investigators observed no therapeutic effect associated with the convalescent plasma in critically ill COVID-19 patients who were treated with convalescent plasma after two weeks of onset and that had indications of pneumonia. Rather, all three patients condition deteriorated and thus required extracorporeal membrane oxygenation treatment. The investigators didn’t include any more severe COVID-19 patients in the convalescent plasma study and recommend significant caution with this approach.
TrialSite provides a brief breakdown of these recently published results.
What research centers were involved with this study?
· Brigham and Women’s Hospital, Harvard Medical School
· Harvard Stem Cell Institute, Harvard Medical School
· Central Hospital of Wuhan, Tongji Medical College, Hua Zhong University of Science and Technology, Wuhan, China
· Zhongnan Hospital of Wuhan University, Wuhan, China
· The Affiliated Lianyungang Hospital of Xuzhou Medical University, Lianyungang, China
· Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou, China
· Renmin Hospital of Wuhan University, Wuhan, China
Who funded this study?
· Health and Family Commission of Wuhan Municipality
· National Institutes of Health (NIH) T32 HL066987 & NIH/NHLBI Grant
· Singapore Ministry of Health’s National Medical Research Council (under Singapore Translational Research (STaR)
· Xiu Research Fund
What was focus of this study?
Use of convalescent plasma on critically ill COVID-19 patients
What this a randomized trial?
No. This is a observational in nature—focusing on the clinical course of three critically ill patients with COVID-19 receiving convalescent plasma treatments by total immunoglobulin G (IgG) titer collection.
What were the details of the clincial course treatment methods?
The patients were critical condition and positive for SARS-CoV-2, with radiographic and clinical features of pneumonia. The physicians and study team collected IgG titer of 160 (range, 200-225 mL), and patients were then transfused between 20 and 30 days post disease onset at the critical illness stage in addition to standard of care.
What were the results?
No therapeutic benefit was observed with any of the three patients. Rather, in all cases, the patients deteriorated and required extracorporeal membrane oxygenation treatment. The authors reported a possible cytokine storm 4 hours after the infusion of convalescent plasma in the second patient. Consequently, they included no more patients in this endeavor.
What are the author conclusions?
They recommend “extreme caution in using convalescent plasma in critically ill patients more than 2 weeks after the onset of COVID-19 pneumonia.”
The two corresponding authors include:
Li Chai, Department of Pathology, Transfusion Medicine Service, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA
Fen Ai, Department of Emergency, The Central Hospital of Wuhan, Tongji Medical College, Hua Zhong University of Science and Technology, Wuhan, China
Call to Action: Researchers should note this study has limitations in terms of size, etc. But the findings should be noted as well.