Rutgers New Jersey Medical School (NJMS) is presently registering participants for a study on the effectiveness of a medication for monkeypox, according to an article in Rutgers Today.
NJMS Research with a Heart, a research center based out of NJMS, is facilitating this trial as part of a larger nationwide study called the Study of Tecovirimat for Human Monkeypox Virus (STOMP).
STOMP will evaluate how safe and effective tecovirimat is as a treatment for monkeypox. The medication was previously only authorized by the Food and Drug Administration as a treatment for smallpox, according to a resource from the Centers for Disease Control and Prevention.
Under the FDA’s "expanded access" or "compassionate use" protocol, tecovirimat was granted limited approval for investigational purposes specifically in regard to monkeypox in August 2022.
The “expanded access” or “compassionate use” protocol allows for patients diagnosed with fatal or major conditions to use treatment options that are still being tested for human use and have not been authorized for use by the general public, according to a resource from the FDA.
Rutgers serves as 1 of 80 locations nationwide admitting participants for STOMP, according to Debra Chew, an assistant professor of medicine at NJMS and the principal investigator of NJMS's STOMP initiative.
Research with a Heart became involved with STOMP through its membership in the AIDS Clinical Trials Group Network, funded by the National Institutes of Health Division of AIDS, she said. The nationwide study aims to have 500 registered participants across these locations, Chew said.
“Given that treatment data has been limited, it's been challenging to treat patients with monkeypox,” Chew said. “The best way to know whether tecovirimat is beneficial is to do a randomized controlled trial like this.”
STOMP will be run on individuals with validated or assumed cases of monkeypox with symptoms that last for less than two weeks, Chew said.
Within this population, people with serious illnesses, skin conditions or those at risk of contracting illnesses will receive doses of tecovirimat during the trial, she said. These individuals include people who are pregnant, breastfeeding or immunocompromised.
“This study will also provide data on whether tecovirimat will be beneficial for certain populations, such as children and pregnant women, where current data are lacking,” Chew said.
She said people who do not fit into these vulnerable categories but have still contracted monkeypox will receive a two-week dosage of either a control or medicinal pill. Should their symptoms worsen during that time, researchers will offer them a course of tecovirimat.
Chew said the study's researchers are looking for participants from underrepresented communities, who may face diminished access to the medication due to their identities.
During the trial, participants will regularly document any symptoms or conditions and attend both virtual and in-person appointments for eight weeks, she said. The data collected during this time will be useful in determining whether tecovirimat expedites the healing process for patients.
“Hopefully, the results of the trial will lead to tecovirimat being approved for human monkeypox treatment and lead to improved access to this drug for those infected with monkeypox,” Chew said. “I think the STOMP study really aligns with Rutgers NJMS's mission to improve the health of patients and meet current health care needs through pioneering research.”