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July 18, 2022

NIH-led Covid-19 trial shows immune modulator drugs boost survival

The death rate in the infliximab arm was 10% versus 14.5% for the placebo arm.

UNC Gillings School of Global Public Health has reported topline results from the US National Institutes of Health (NIH)-led clinical trial where immune modulator drugs, infliximab or abatacept, showed to boost survival in hospitalised Covid-19 adult patients.

Janssen Biotech’s infliximab (Remicade) and Bristol Myers Squibb’s abatacept (Orencia) are drugs that are intended for treating some autoimmune diseases.

Named the ACTIV-1 Immune Modulators clinical trial, the randomised, placebo-controlled trial was supported by the Duke Clinical Research Institute (DCRI) and the UNC Gillings School of Global Public Health.

The trial analysed whether some therapies that aid in lowering the effects of an overactive immune response could expedite recovery and lower mortality in adults admitted to the hospital with moderate to severe Covid-19.

The ACTIV-1 master protocol comprised three sub-studies with each one analysing an immunomodulator drug versus a common placebo arm. 

Furthermore, they were also given local standard of care of either Gilead Sciences’ remdesivir (Veklury) or dexamethasone.

The clinical status of the subjects was assessed every day as per an eight-point scale ranging from not hospitalised with no limitations on activities to mortality. 

According to the findings, subjects who received infliximab showed a robust but not statistically significant improvement on the primary endpoint of time to recovery as evaluated by day of hospital discharge, versus placebo. 

At 28 days, improvements for both key secondary endpoints of mortality and clinical status were statistically significant. 

The death rate in the infliximab arm was 10% versus 14.5% for the placebo arm.

Subjects in the infliximab arm had 43.8% improved better chances of clinical improvement versus placebo.

Furthermore, subjects treated with abatacept showed a robust but not statistically significant improvement in time to recovery. 

Subjects in the abatacept arm had a death rate of 11% versus 15% in the placebo arm. 

A 34.2% improved chance of clinical improvement was seen in the abatacept arm compared to the placebo. 

NIH acting director Lawrence Tabak said: “These promising ACTIV-1 results demonstrate the collaborative power of public-private partnerships to accelerate therapeutic answers during this unprecedented global health crisis. 

“The innovative ACTIV model is bringing greater clarity to the search for effective, evidence-based Covid-19 treatments.”

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