Coronavirus Drug and Vaccine Studies Are Recruiting Their First Volunteers

As COVID-19 continues to spread both around the world and in the U.S., two separate efforts to find a medical solution to the virus are moving forward. At the University of Nebraska, the first patients have volunteered to test an experimental drug to treat COVID-19. And at Kaiser Permanente Washington Health Research Institute, researchers have begun recruiting people to test a possible vaccine.

A number of U.S. passengers aboard the Diamond Princess cruise ship were brought to Nebraska for quarantine; two of these passengers have agreed to participate in a trial for remdesivir, an antiviral drug originally developed for Ebola, but which showed encouraging results in animals in fighting SARS and MERS, two other illnesses caused by coronaviruses.

The drug is designed to treat infections that are moderate to severe, and is targeted to those with the most intensive symptoms. In order to qualify for the remdesivir study, run by the National Institute of Allergy and Infectious Diseases (NIAID), patients must test positive for COVID-19 and have pneumonia. Of the more than two dozen people diagnosed with COVID-19 from the cruise ship who were brought to Nebraska for quarantine, four required hospitalization and two developed pneumonia. Those two patients were asked if they wanted to volunteer for the study, and both agreed, says Dr. Andre Kalil, professor of medicine in the division of infectious disease at University of Nebraska Medical Center.

The study will eventually include 400 patients; initial results won’t be analyzed until the first 100 have completed treatment. Given the relatively low rate of moderately to severely affected patients in the US at this point, Kalil says that NIAID plans to collaborate with health officials from other countries with higher case volumes, including Korea, Japan and Italy. For now, the trial will stay open for three years in order to recruit the needed number of patients.

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This study, says Kalil, is also designed to be more flexible than most drug trials. “This is not just a remdesivir trial,” he says. “It will test as many [COVID-19] therapies as possible, and remdesivir is just the first. Let’s say a couple of months from now, we realize that remdesivir is a good drug, that it works better than placebo…. Then patients receiving the placebo would be offered the drug and we would move on to test another drug. If remdesivir turns out not to be effective, then we would remove it from the study and bring another drug to test against placebo. It’s a dynamic, fast way to run a randomized trial.” The design is a way to accelerate testing of antiviral drugs against COVID-19, since infections are on-going and there is no treatment yet.

Meanwhile, other labs are working on developing vaccines that would provide some protection against the virus in the first place. The vaccine study that is furthest along (and which is also overseen by NIAID) is currently recruiting its first participants at Kaiser Permanente Washington Health Research Institute. Unlike the remdesivir trial, this study will enroll healthy volunteers. Dr. Lisa Jackson, lead investigator on the study, says 45 healthy people will be recruited to test three different doses of the vaccine.

Kaiser is currently getting thousands of daily online requests from people interested in participating. Researchers are contacting the volunteers by phone to assess their eligibility for the study. Once the participants are chosen, they will be given one of the three vaccine doses being tested. The scientists will track patients’ immune responses after that injection, and then give each patient a second injection (of the same dosage). The goal is to figure out which dosage is most effective, and whether one or two shots of that dosage is needed.

They’ll be looking for levels of antibodies that the body’s immune system produces against the so-called spike protein, one of the proteins that stud the surface of the SARS-CoV-2 virus responsible for causing COVID-19. Scientists will analyze antibody levels in the participants a year after their second vaccination, so results won’t be available for at least 12 to 18 months, says NIAID director Dr. Anthony Fauci. Given that coronaviruses like the one behind COVID-19 seem to be appearing more frequently, however, having a vaccine against this particular virus could be useful in creating future coronavirus vaccines as well.

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