B&B Faculty Issue Update on COVID-19 Clinical Trials Discussion

Recent Updates

Feb. 26, 2020

B&B Faculty Michael Pencina and Sheng Luo recently discussed the design of two new Phase 3 clinical trials testing a potential treatment for coronavirus.  Both Dr. Pencina and Dr. Luo are affiliated with the Duke Clinical Research Institute (DCRI).  

Sheng Luo, PhD, explained that remdesivir, the treatment being tested in these two trials, was originally developed to treat the Ebola virus and has already gone through Phase 1 and Phase 2 trials.

Enrollment for the two trials is based on the severity of the disease. One of the trials is enrolling 308 patients with mild to moderate cases of coronavirus, while the other is enrolling 452 patients with severe cases. The primary outcome for the mild/moderate trial is complete recovery, while the primary outcome for the severe trial is recovery on a six-point scale.

Both trials are randomized and placebo-controlled. The randomization is important, said the DCRI’s Michael Pencina, PhD, to ensure that the treatment actually works. Without randomization, he explained, it might happen that the treatment is given to patients with less severe cases, leading to skewed results about the treatment’s effectiveness.

The study is also blinded, meaning that neither the patients nor the investigators know which patients are receiving the treatment and which are receiving the placebo. This is critical, Pencina said, to avoid bias within the study.

The trials are slated to run until April, but Pencina pointed out that an interim analysis, conducted before the trial is over, would be important, as time is of the essence in determining results. Investigators cannot be involved in analyzing the data as it accumulates because it could result in bias; therefore, an independent data monitoring committee would need to oversee such analysis. If the treatment looks promising at the interim analysis, he said, the study could be terminated at that point for overwhelming efficacy.

More than 1,000 deaths have already been attributed to coronavirus, a novel virus which emerged in Wuhan, China in December. The World Health Organization declared a global health emergency on Jan. 30. For Luo, the crisis is personal. He earned both his undergraduate and his master’s degree in Wuhan from Huazhong University of Science and Technology, and his in-laws still live in Wuhan.

This article was originally published in the Duke Clinical Research Institute.