North Carolina Researchers Launch ‘Promising’ Coronavirus Clinical Trial

Doctors say they don’t believe drug to be a ‘cure,’ but they hope it eases symptoms.

Clinical trials typically take four months to pull together. A new North Carolina-centered trial aimed at combating the dangerous symptoms of COVID-19 took about 11 days.

Doctors at Atrium Health’s Levine Cancer Institute in Charlotte said the urgency of coronavirus’ spread in North Carolina and across the globe lent speed to their new Charlotte-area trial, which aims to test the impacts of the cancer drug selinexor.

“To be able to offer hope for a treatment option is an amazing feeling,” Dr. Zainab Shahid, the trial’s principal investigator and medical director of bone marrow transplant infectious diseases at the Levine Cancer Institute, told reporters Tuesday. 

Doctors emphasized that selinexor is not believed to be a “cure” for COVID-19, but they hope that it may alleviate the worst symptoms of the deadly virus, which include acute respiratory issues. 

“We are trying to decrease the burden of illness,” Shahid said. “Decrease the morbidity for patients.”

NC officials report that the virus has been confirmed in more than 9,500 people in 96 of the state’s 100 counties. As of Tuesday morning, COVID-19 had killed 342 people in North Carolina, and more than 53,000 in the US. 

“To be able to offer hope for a treatment option is an amazing feeling.”

Dr. Zainab Shahid, principal investigator of the COVID-19 clinical trial.

During the international trial, the drug will be administered every other day to patients with moderate to severe symptoms. Researchers will check on patients to see if they are tolerating the medicine. Atrium Health is hoping to enroll 250 people across the world in the trial.  

Shahid’s team will enroll one to two patients a week through Atrium Health’s Carolinas Medical Center in Charlotte, Atrium Health Cabarrus in Concord, Atrium Health Pineville and Atrium Health University in Charlotte.

Even in a best-scenario, however, researchers said it would take months to clear the drug for use on a wider scale if it is effective.

The clinical trial comes at an extraordinarily busy time for COVID-19 researchers while the world awaits a vaccine. UNC researchers are testing their own potential treatments, as are doctors at Novant Health and Duke Health. 

The World Health Organization launched four promising international trials last month for potential coronavirus treatments, testing World War II-era malaria drugs, an existing drug combo used to treat HIV, and one antiviral originally intended to treat ebola.

Shahid said that selinexor had promising results when tested in a petri dish, killing the virus. 

“To me, that is very encouraging,” Shahid said. “Because I haven’t seen a lot of that related to COVID-19 thus far.”

“We know the fast pace in which everything is moving right now, and we appreciate the tremendous level of collaboration this entailed,” Phil Butera, assistant vice president for clinical trials at Levine Cancer Institute, said in a statement. “We worked tirelessly to make this happen so we can bring a hopeful opportunity to patients who are in need of treatment options, as so much is not known about this virus.”

Atrium Health researchers noted that, until just days ago, doctors believed the drugs hydroxychloroquine or chloroquine to be potential treatment options, although the U.S. Food and Drug Administration (FDA) now warns patients against using those drugs outside of a hospital due to the risk of heart complications.