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NIH Begins Covid-19 Antibody Trials

Global Covid-19

(Gerd Altmann, Pixabay)

5 Aug 2020. National Institutes of Health is beginning clinical trials of experimental antibody therapies to treat Covid-19 infections in people with symptoms ranging from mild to severe. The first treatment tested in the mid- and late-stage studies is an engineered antibody developed by drug maker Eli Lilly and Co., biotechnology company AbCellera Biologics, and the Vaccine Research Center at National Institute of Allergy and Infectious Diseases, part of NIH.

The trials are part of NIH’s Accelerating Covid-19 Therapeutic Interventions and Vaccines, or Activ, program 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.

Both the Activ-2 and Activ-3 clinical trials 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. With these common rules, standards, and practices in place, adaptive trials make it possible to evaluate drugs and devices quicker, add new population groups to a study, or close treatment interventions if needed, even as data are being collected.

First treatment assessed: LY-CoV555

LY-CoV555 is a product of Eli Lilly and Co. in Indianapolis and AbCellera Biologics in Vancouver, British Columbia, Canada. AbCellera uses what it calls deep mining of B-cells from the immune system to discover antibodies for preventing and treating diseases caused by a range of viruses and bacteria. B-cells are white blood cells in the immune system that produce antibodies, proteins that directly attack invading pathogens, such as bacteria and viruses.

As reported by Science & Enterprise in March, AbCellera says it screened more than five million immune-system cells against a blood sample from one of the first people in the U.S. infected with novel coronavirus. From this screening, AbCellera says it identified some 500 unique human antibody sequences that respond to the SARS-CoV-2 virus responsible for Covid-19 infections. From this screening and help from Vaccine Research Center at NIAID, the companies developed LY-CoV555, an engineered immunoglobulin G antibody designed to block the SARS-CoV-2 spike protein that penetrates and infects cells.

Eli Lilly and AbCellera share LY-CoV555’s development work, while Lilly is responsible for further development, regulatory approvals, manufacturing, and distribution. Earlier this week, the companies said they’re testing LY-CoV555 among residents and staff in long-term care facilities in the U.S.

Activ-2 and -3 clinical trials

The Activ-2 trial is testing treatments for people infected with SAR-CoV-2 viruses responsible for Covid-19, but not requiring hospitalization. The study is initially enrolling 220 participants, randomly assigned to receive an LY-CoV555 infusion or a placebo. Participants will then be tracked for the next four weeks, checking for adverse reactions to the treatment, and tested for SAR-CoV-2 in nasal and saliva samples, blood oxygen levels using a pulse oximeter, and antibody concentrations in blood samples. The main efficacy measures are prevention of hospitalization and survival time of participants.

If results from the first 220 participants look promising, the Activ-2 trial will add a larger-scale sample of 1,780 participants, also individuals with Covid-19 infections, but not needing hospitalization. These participants will also be randomly assigned to receive LY-CoV555 or a placebo, and be assessed for 28 days with similar samples and measures as the smaller group.

The Activ-3 trial is testing LY-CoV555 among patients hospitalized with Covid-19 infections. Like the Activ-2 trial, Activ-3 is first recruiting a sample of 300 participants with Covid-19 and displaying no more than moderate symptoms, randomly assigned to receive LY-CoV555 infusions or a placebo. All patients in the trial are also receiving the antiviral drug remdesivir, approved by FDA as a treatment for advanced Covid-19 infections. After five days, patients are assessed for adverse reactions to the treatment and severity of their symptoms, including the need for supplemental oxygen, use of a ventilator, or other supportive care.

If results from this first group show LY-CoV555 is safe and effective, Activ-3 will add 700 more participants to the sample, although the new patients will include more severe cases, including those needing mechanical ventilation and with organ failure other than the lungs. The main efficacy measure is sustained recovery of patients for 14 days following release from the hospital.

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