Immunoglobulins fail to show efficacy in NIH trial of hospitalised COVID-19 patients

According to topline results unveiled Friday, a Phase III trial conducted by the US National Institutes of Health (NIH) evaluating investigational immunoglobulin treatments for hospitalised COVID-19 patients did not meet its endpoints. Four companies provided investigational anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig) materials for the ITAC study, including CSL Behring and Takeda on behalf of the CoVIg-19 Plasma Alliance, as well as Emergent BioSolutions and Grifols.

The ITAC study, also known as INSIGHT-013, assessed immunoglobulin candidates in 593 adults hospitalised for COVID-19. Patients were eligible for the trial if they had symptoms for 12 days or less, without life-threatening organ dysfunction or end-organ failure. Participants were randomised to receive a single infusion of placebo or H-Ig, a highly concentrated solution of SARS-CoV-2-neutralising antibodies derived from the plasma of recovered COVID-19 patients. These were given on top of standard of care, which included Gilead Sciences' antiviral medicine Veklury (remdesivir).

No clinical benefit 

The primary objective of the study was to compare clinical status of patients in each group on day seven using a seven-point ordinal outcome scale. Secondary endpoints looked at clinical status of patients at other timepoints, all-cause mortality through day 28, time to worsening, time to recovery and discharge status, among other outcomes.

Both the CoVIg-19 Alliance and Emergent issued separate statements Friday saying their respective anti-SARS-CoV-2 hyperimmunoglobulin treatments, CoVIg-19 and COVID-HIG, did not provide clinical benefit to hospitalised COVID-19 patients when added to standard of care, inclusive of Veklury. No serious safety concerns were identified in either case. Analyses remain ongoing and the NIH's National Institute of Allergy and Infectious Diseases (NIAID), along with the NIAID-funded INSIGHT Network, plan to publish full results soon.

CoVIg-19 Alliance disbands

"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 programme may contribute to a growing understanding of this challenging virus and strategies for patient care," commented Bill Mezzanotte, who heads R&D at CSL Behring and is co-leader of the CoVIg-19 Alliance. Following the outcome of the ITAC trial, the CoVIg-19 Plasma Alliance, which was set up about a year ago to accelerate development of a plasma-derived H-Ig therapy for COVID-19, stated that its "work now concludes."

Meanwhile, Laura Saward, therapeutics business unit head at Emergent, said "we recognise that, similar to other antibody-based therapies, intervention with COVID-HIG earlier in the disease course may be necessary to impact COVID-19 in patients." She noted that Emergent will "continue to explore COVID-HIG as a treatment in ongoing clinical trials." COVID-HIG is also being developed as a potential treatment for COVID-19 outpatients at high risk of progression to severe disease with funding from the US Biomedical Advanced Research and Development Authority (BARDA).

Tough week for Emergent

The news comes shortly after it became public that Emergent, which is helping to make Johnson & Johnson's coronavirus vaccine, botched production of a batch of the vaccine at its plant in Baltimore. The Emergent facility in question has not yet been certified by the FDA to produce the Johnson & Johnson vaccine.

To read more Top Story articles, click here.