(National Heart, Lung, and Blood Institute, NIH)
14 May 2020. A clinical trial testing treatments for lung damage in severe Covid-19 cases is adding the anti-viral drug remdesivir and convalescent plasma to its protocol. The adaptive clinical trial is conducted by Kinevant Sciences GmbH in Basel, Switzerland, a company in the Roivant Sciences group of life science enterprises.
One of the more common complications of Covid-19 infections in severe cases is acute respiratory distress syndrome, or ARDS, a life-threatening condition where fluid leaks into the lungs. ARDS is often triggered by injury to the lungs, and in the case of Covid-19 infections, from inflammation reacting to the SARS-CoV-2 virus responsible for the infections. The fluid build-up makes breathing difficult and adequate oxygen does not get to the body, requiring supplemental oxygen or mechanical ventilation for weeks at a time in some cases.
The clinical trial is testing the synthetic antibody gimsilumab developed by Kinevant Sciences as a treatment for ARDS from Covid-19. Gimsilumab is designed to limit production of granulocyte macrophage-colony stimulating factor, or GM-CSF, an enzyme produced by the immune system, and invoked by pathogens such as the SARS-CoV-2 virus responsible for Covid-19. GM-CSF is believed to trigger the lung inflammation experienced in ARDS, and in preclinical studies, according to Roivant, gimsilumab blocks effects of GM-CSF to stop lung cell inflammation.
Roivant tested gimsilumab with healthy volunteers in an early-stage study and found the antibody was safe and well-tolerated. The new mid-stage clinical trial is enrolling some 270 participants with Covid-19 infections at seven sites in the U.S. The study team followed the first 10 percent of participants looking specifically for safety issues with gimsilumab, and the company says an independent monitoring committee recommending continuing with the trial.
For the remainder of the trial, participants are randomly assigned to receive gimsilumab first in a high dose, than one week later in a low dose, or a placebo, with participants then followed for 22 days. The low dose of gimsilumab may be omitted if the patient is discharged from the hospital or no longer needs supplemental oxygen. The study is looking primarily at patient mortality as its measure of effectiveness.
The study uses an adaptive design that allows for altering factors such as treatment regimens or sample sizes based on interim results. Adaptive trials often are governed by a master protocol, where a single basic study structure can test a series of treatments, making it possible to accommodate new treatments, samples, or changes in direction without starting from scratch. In April, Science & Enterprise reported on another adaptive clinical trial assessing 10 to 20 drugs treating ARDS.
In this trial, the adaptive design allows for testing other treatments with gimsilumab, and the study team plans to combine gimsilumab with anti-viral drugs like remdesivir by Gilead Sciences, which on 1 May received an emergency authorization from FDA to treat severe Covid-19 infections. The researchers also plan to test gimsilumab with convalescent plasma donated by recovered Covid-19 patients containing potential therapeutic antibodies.
“The adjustments to our protocol reflect our desire to ensure patients receive the best possible treatment,” says Simon Lowry, Kinevant Sciences chief medical officer in a Roivant statement. “We believe gimsilumab may prove to be complementary with anti-virals and convalescent plasma and anticipate providing a definitive answer to the question of whether an anti-GM-CSF antibody can provide benefit to Covid-19 patients.”
Roivant Sciences, based in London and Basel, is a collection of companies each formed to address a specific need. Roivant calls the individual companies Vants with each of the companies focusing on a particular disease or technology type.
More from Science & Enterprise:
- FDA Issues Covid-19 Therapy Trials, Review Guidance
- Trial Tests Blood Pressure Drug as Covid-19 Treatment
- Limited Covid-19 Benefits Found for Arthritis Drug
- Covid-19 Antibody Therapy Prepares for Trial
- Anti-Viral Drug Treats Some Severe Covid-19 Cases
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