Duke joins first national study testing potential therapy for COVID-19

Coronavirus

DURHAM, N.C. (WNCN) — Duke University Hospital has now joined the first national study that will test a possible therapy for COVID-19, according to a news release from Duke Health.

The study will give hospitalized adult patients “with significant symptoms” the opportunity to participate.

The treatment that’s being studied is known as remdesivir and it’s an antiviral agent that has been tested in both humans and animal studies for various different diseases, according to Duke.

Remdesivir has been tested in humans with Ebola and in animal studies against MERS and SARS, which are both diseases that evolved from different strains of coronavirus, the release states.

Duke will begin enrolling eligible patients immediately.

“Duke’s participation in this national study creates an extra option for potential patients in our community who have serious complications from COVID-19,” said Cameron Wolfe, M.D., the study’s principal investigator, in the news release. “Currently, there are no approved therapies for this disease, so we are eager to contribute in any way to help find ways to fight this global pandemic.”

Patients in the study will be randomly assigned to either receive remdesivir or a mock treatment. The study is “designed to evaluate the safety and effectiveness of remdesivir.”

All participants will first undergo a baseline physical exam and “must have significant symptoms such as difficulty breathing, using supplemental oxygen or needing mechanical ventilation,” according to Duke.

“The trial is limited to people in the hospital with more severe symptoms, because most people with COVID-19 will recover fine at home with no need for therapies,” said Emmanuel “Chip” Walter, M.D., co-investigator on the study. “We do not want to expose people with mild or no symptoms to a therapy that could have potential side effects.”

Number of COVID-19 tests completed in North Carolina

  • March 18: 1,850
  • March 19: 2,505
  • March 20: 3,233
  • March 21: 5,276
  • March 22: 6,438
  • March 23: 8,438
  • March 24: 8,502
  • March 25: 10,489
  • March 26: 12,910
  • March 27: 15,136

Participants in the treatment group will receive a daily dosage of the drug for up to 10 days. The placebo group will receive inactive ingredients. All patients will be checked up on daily for any measurable changes in ther conditions, according to Duke.

According to the release, “Trial data will be pooled from all the participating clinical sites roughly mid-way through the enrollment period and analyzed to determine whether changes should be made to the study’s design.”

The study could be halted or revised to add another treatment that might boost the response if patients show no benefit at the midpoint of the study, Duke says.

“We need to be able to move quickly, and this sort of study design will help us understand sooner rather than later whether the therapy is beneficial,” Walter said.

The study is funded by the National Institute of Allergy and Infectious Diseases and managed by the Frederick National Laboratory for Cancer Research. Gilead Sciences Inc. developed remdesivir and is supplying it for the study, the release states.

“Facing an urgent need to find treatments for COVID-19, we are able to rely on decades of collaborative work among the many talented teams at Duke to advance the knowledge and treatment of infectious diseases,” said Mary E. Klotman, M.D., dean of the Duke University School of Medicine.

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