LOS ANGELES - ViralClear, a subsidiary of BioSig Technologies, Inc., a medical technology company, announced the postponement of a Phase 2 “hospitalized” trial for its experimental coronavirus treatment.
The trial consisted of a double-blind, placebo-controlled study in order to test the effectiveness and safety of the company’s treatment combining intraveneous injections of remdesivir and an oral solution of a drug called Merimepodib in adult patients with advanced complications of COVID-19.
Merimepodib is an antiviral drug that has been found in previous studies to have a strong impact on COVID-19 while remdesivir was recently approved by U.S. regulators Oct. 22, for treatment of the novel coronavirus.
According to the company, the trial had expanded in size from 40 to 80 hospitalized coronavirus patients, which ViralClear said limited enrollment to seriously ill patients.
ViralClear’s Safety Monitoring Committee (SMC) said it found “an imbalance in survival rates” in patients who required oxygen, which the company said could make it unlikely for the trial to “meet its primary safety endpoints.”
“The company has therefore elected to stop enrollment into the clinical trial. Patients will be followed as per the protocol for safety monitoring; however, no further study drug treatments will be administered,” ViralClear said in a news release.
There was no additional information in regards to the effectiveness of the antiviral drug Merimepodib and its combination with remdesivir.
FILE - A member of the dialysis prepares to treat a patient with coronavirus in the intensive care unit at a hospital on May 1, 2020 in Leonardtown, Maryland. (Photo by Win McNamee/Getty Images)
Remdesivir had been authorized for use on an emergency basis since spring, and now is the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month.
The drug works by inhibiting a substance the virus uses to make copies of itself. Certain kidney and liver tests are required before starting patients on the drug to ensure it's safe for them and to monitor for any possible side effects. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness.
Its price has been controversial, given that no studies have found it improves survival. Last week, a large study led by the World Health Organization found the drug did not help hospitalized COVID-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit. The FDA's approval statement noted that, besides the NIH-led one, two other studies found the drug beneficial.
The Associated Press contributed to this story.