Results of the latest phase of an international clinical trial of the experimental antiviral drug remdesivir point to a shortened recovery time and reduced mortality rate for critically ill COVID-19 patients, according to officials at University Health System, which is conducting the world’s largest trial of the drug.
Local researchers are hoping use of the drug will help reduce hospital stays as remdesivir becomes more widely available. UT Health San Antonio, in partnership with UHS, wrapped up enrollment for phase two of the global clinical trial at the end of June, with treatment continuing through the end of July.
University Hospital is the lead enrollment site worldwide for the trial sponsored by the National Institutes of Health’s Institute of Allergy and Infectious Diseases, Nearly 100 patients have enrolled in the trial since April, when phase one began in Bexar County.
The trial is the first in the U.S. to evaluate an experimental treatment for COVID-19.
Brooke Army Medical Center is also among the dozens of clinical trial sites for remdesivir, which works by blocking the reproduction of the novel coronavirus and is given intravenously.
UHS is analyzing data from 96 patients enrolled in its phase two trial, which studied remdesivir in combination with the anti-inflammatory drug baricitinib.
Researchers looked at whether baricitinib, which is approved as a treatment for rheumatoid arthritis, combined with remdesivir can prevent or reduce hyper-inflammation that can fatally overwhelm the lungs and other parts of the body in people with COVID-19, Patterson said.
While the results have not been finalized, Patterson said that extremely sick patients “felt significantly better almost immediately” following remdesivir, and some had improvement in muscle aches and pains, which could be attributed to taking baricitinib, which was given at random, with some patients receiving a placebo.
Researchers are still completing followups with patients to determine if side effects from other drugs could have affected their condition, but UHS patient outcomes are similar to data published by California-based biopharmaceutical company Gilead Sciences Inc., which developed remdesivir.
The company on July 10 announced findings from a comparative analysis showing remdesivir treatment was associated with “significantly improved clinical recovery” for the 312 patients enrolled in its phase three trial. The study compared data and outcomes for 818 patients treated in separate hospital settings who had similar characteristics and disease severity and received standard care during the same period.
The findings showed that nearly 8 percent of patients treated with remdesivir died compared with 12.5 percent of patients in the analysis who did not receive remdesivir. The analysis also found that over 74 percent of patients who received treatment with remdesivir recovered in 14 days or less compared with 59 percent of patients who received standard care alone.
Remdesivir has shown promise in laboratory and animal tests against COVID-19 and several other related viruses, and has been tested in humans with ebola, Patterson said. It also has been tested in animals in studies of the Middle Eastern respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses, according to NIH officials.
Patterson said that while remdesivir is effective, it’s not easy to obtain unless you’re participating in clinical trials that provide access to the drug.
The NIH provides UHS with remdesivir, but other local hospitals have struggled to obtain the product, which Gilead Sciences was not manufacturing regularly until late March.
Baptist Health System has 893 vials of remdesivir – enough to treat 148 patients – available for patients to purchase, according to an internal COVID-19 update from the hospital system.
For private insurance plans, Gilead Sciences set a list price of $520 per vial. The cost for a five-day treatment course using six vials, which most patients are expected to receive, would add up to $3,120.
For government-run health care providers the price will be lower, at $390 per vial or $2,340 per course.
Gov. Greg Abbott on July 4 announced that the Texas Department of State Health Services (DSHS) was distributing 448 cases of remdesivir to 157 hospitals across Texas – enough to treat approximately 1,792 patients.
UHS received enough remdesivir to treat 63 patients who are not in the trial, Patterson said, and supplies are allocated by the DSHS according to the number of COVID-19 patients at a hospital.
Dr. Paul Hancock, chief medical officer with Methodist Healthcare, said the amount of remdesivir distributed by the state to the San Antonio area was a “fair amount” given patient count and medication availability.
Phase three of the UHS remdesivir trial will look at whether remdesivir combined with interferons, a type of antiviral drug that has been used clinically for years, speeds up recovery time and/or reduces levels of inflammatory proteins in COVID-19 patients.
Patterson said that the trial will be enrolling soon and will be open to any hospitalized COVID-19 patient at UHS who meet enrollment qualifications.
“Unfortunately the virus is steadily present and isn’t going away any time soon,” Patterson said. “The need for treatment is going to continue, so we have to keep working to have options available.”