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NIH Trial Testing Current Drugs to Treat Covid-19

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13 Oct. 2020. A clinical trial is planned to assess two drugs designed for other medical conditions as treatments for Covid-19 infections. The ACTIV-5 Big Effect Trial is part of the Accelerating Covid-19 Therapeutic Innovations and Vaccines, or ACTIV, program of National Institute of Allergy and Infectious Diseases, or NIAID, part of National Institutes of Health.

The Big Effect Trial aims to give an early evaluation of the two current drugs’ potential as treatments for people with Covid-19 infections, with those showing promise then fully assessed in a large-scale late-stage study. One of the drugs is risankizumab, developed by drug makers AbbVie and Boehringer Ingelheim, approved to treat severe plaque psoriasis, and in testing for other autoimmune conditions, where the immune system is tricked into attacking healthy cells or tissue. Risankizumab is a synthetic antibody that blocks interleukin-23, a cytokine enzyme that encourages inflammation in autoimmune disorders.

The other drug is lenzilumab, also a synthetic humanized antibody, designed originally to reduce the cytokine overreactions found with chimeric antigen receptor or CAR T-cell treatments for cancer. Lenzilumab, made by Humanigen Inc. in Burlingame, California, is also being evaluated as a treatment for cytokine storms from Covid-19 infections in a late-stage clinical trial with the Mayo Clinic and Dartmouth University.

The mid-stage clinical trial will enroll 200 participants hospitalized for Covid-19 symptoms at six medical centers in the U.S. Participants will be randomly assigned to receive risankizumab or lenzilumab, combined with the anti-viral drug remdesivir, or remdesivir alone plus a placebo. Remdesivir is authorized by FDA to treat severe Covid-19 symptoms. Recipients of risankizumab will receive a single intravenous dose, while participants receiving lenzilumab will get a total of three intravenous doses.

The study team is looking primarily for ability of the drugs to improve the clinical status of patients, compared to remdesivir alone. Clinical status in this case is measured on an eight-point scale ranging from (1) for not hospitalized and with no limitations on activities to (8) for death, after eight days following treatment. The researchers are also looking for the amount of time patients need for hospitalization and recovery, changes in a range of biomarkers for 29 days after treatment, and reports of adverse effects.

“The goal here is to identify as quickly as possible the experimental therapeutics that demonstrate the most clinical promise as Covid-19 treatments and move them into larger-scale testing,” says NIAID director Anthony Fauci in an institute statement. “This study design is both an efficient way of finding those promising treatments and eliminating those that are not.”

NIH’s Activ program seeks to streamline and coordinate actions to combat the Covid-19 pandemic among agencies in the U.S. government, private pharmaceutical and biotech companies, international agencies, and not-for-profit groups. Among Activ’s goals is to accelerate evaluation of vaccine and therapy candidates to speed regulatory approval, including clinical trials of experimental drugs. In September and August, Science & Enterprise reported on other Activ trials testing anti-coagulant treatments for blood clots caused by Covid-19 and experimental antibody therapies to treat infections.

Trials in the Activ program use an adaptive design that allow for changing the course of the study while underway, without compromising gold-standard quality of the efficacy or safety data. Adaptive trials are usually governed by a single governing board and master protocol spelling out ground rules for the study, including standards and processes for assessing results, adding or closing sample groups, and adding new drugs or devices for testing.

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