Treatment with anti-coronavirus hyperimmune intravenous immunoglobulin (CoVIg-19) did not reduce the risk of progression to severe COVID-19 when added to standard care including remdesivir, according to findings from the phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin clinical trial. Representatives from the CoVIg-19 Plasma Alliance, which formed in April 2020 to help develop CoVIg-19 as a potential therapy for COVID-19, announced on Friday
that the trial did not meet its endpoints to show efficacy in adults hospitalized with COVID-19.
CoVIg-19 is manufactured from COVID-19 convalescent plasma (CCP) and contains a highly concentrated solution of antibodies intended to neutralize SARS-CoV-2. Investigators randomized 600 adult patients at 63 sites in the United States and 10 other countries to receive either CoVIg-19 plus standard care or placebo plus standard care. Patients were eligible for the trial if they had been hospitalized for COVID-19 and had symptoms for 12 days or fewer without life-threatening organ dysfunction or end-organ failure. Additional information about the trial is available online
In light of these findings, co-leader of the CoVIg-19 Alliance
Bill Mezzanotte, MD, MPH, executive vice president, head of Research and Development and chief medical officer at CSL Behring, announced that the work of the CoVIg-19 Plasma Alliance will conclude.
“While the results of this particular clinical trial are disappointing, we are proud that as an industry we proactively and collaboratively pursued this work, and that the program may contribute to a growing understanding of this challenging virus and strategies for patient care,” Mezzanotte said.
In response to the findings, AABB’s Chief Medical Officer Claudia S. Cohn, MD, PhD, noted that many factors – including the timing of administration – may affect the clinical benefit of CoVIg-19. “The results of this trial are certainly disappointing,” Cohn said. “While I thought that the greater dose of anti-SARS-CoV-2 antibody would show benefit for COVID patients, it is possible that the CoVIg-19 was administered too late in disease. Of course, many other factors may be involved.
“Passive immune therapies such as CoVIg-19 and CCP have not shown significant benefit for COVID patients with the notable exception of the Argentine trial
, in which patients were treated with CCP very early in disease. We must wait for the results of the trial testing CCP in outpatients
that is being led by David Sullivan, MD, of Johns Hopkins to see if the findings from Argentina can be confirmed.”
AABB plans to discuss findings from the trial at an upcoming AABB Thursday Forum
, a weekly Zoom call to discuss two pressing issues related to platelets and CCP. The Thursday Forum takes place each Thursday at 12 p.m. ET. AABB encourages members of the blood community to attend, connect with peers at other institutions and to ask questions related to these topics. Registration is not required.