This week, three major health systems in South Dakota will join together to launch clinical trials of the drug most commonly used to treat malaria, lupus and rheumatoid arthritis. You’ve no doubt heard the hype surrounding hydroxychloroquine, especially from the president himself:
“I would love to go to a laboratory and spend a couple of years testing something. We don’t have time. We don’t have two hours because there are people dying right now. If it does help, great. If it doesn’t help, we gave it a shot.” President Trump said on April 5
Clinical trials on hydroxychloroquine have been fast-tracked all over the country with at least a dozen currently underway. As South Dakota embarks on its first week of trials, we talk with medical investigators who already are well into the process.
“We are going on offense to help every single person to deal with this virus and are willing to fight it and get better and go home to their families,” Governor Kristi Noem said on April 13.
Those were Governor Noem’s remarks with the announcement of statewide clinical trials of hydroxychloroquine being led by Sanford, Avera and Monument Health.
The University of Minnesota has a month head start on testing the drug. Researchers there are looking at whether hydroxychloroquine can prevent COVID-19 in people who have been exposed, or treat those who are not yet hospitalized.
Dr. Caleb Skipper is the co-investigator of the trials, which are random, double-blind and placebo-controlled.
“So what that means is both the participant and the investigators like myself are blinded to what drug any given participant is given,” University of Minnesota Medical Research Fellow, Dr. Caleb Skipper said.
An independent data safety monitoring board analyzes the data to make sure the trial is safe for patients.
“So far we had our first inter-analysis and that did pass and so the trial is continuing. But I can’t actually answer whether the drug is working or not—which is part of the robustness of the science in order to make sure we are doing this properly.”
Dr. Caleb Skipper, University of Minnesota infectious disease postdoctoral fellow
The University of Minnesota is taking applicants for the study online nationwide If someone qualifies they get the drug overnight via Fed-Ex.
Dr. Skipper: In some ways that’s kind of a novel thing that we can potentially help other researchers and trials sort through those logistics.
Kennecke: Is this something in the U.S. where you see it’s very important that there’s a collaboration among all these trials?
Dr, Skipper: I think particularly in the setting of an epidemic, there’s even more impetus on us to collaborate so actually we have been in talks with Sanford, preliminary, about being able to share our data and share our operational logistics.
The U of M trials are using a different dosage of the medication than in South Dakota. One thing all research scientists stress is that they must steer clear of false hope.
“We have some very good results and some very good tests. You’ve seen the same tests that I have. In France, they had a very good test,” President Trump said on April 5.
However, the medical society that published that French study, now says it did not meet scientific standards.
“There’s a lot of risk of bias of how and when those medication were given to those patients. So for us to hang our hats on that is very difficult without having studied it properly in a scientific way,” Dr. Dr. Abhijit Duggal of the Cleveland Clinic said.
Dr. Abhi Duggal of the Cleveland Clinic is an ICU physician, and also the director of clinical research. The Cleveland Clinic is part of a network of 40 sites in the U.S. taking part in a trial of the drug, which is separate from South Dakota’s.
Kennecke: How long will it take before you have results?
Dr. Duggal: The study is going to enroll 510 patients all across the nation. We just started the study last week and in the first week we’ve enrolled 25 patients across four sites.
Doctors across the nation have also warned about the potential adverse side effects of the drug, which include heart complications.
“What we need to remember is we want to be using these drugs, only if we are seeing a beneficial effect from them because there’s always the potential of side effects,” Dr. Duggal said.
The pandemic has sped up the process for scientists, allowing them to get answers to these questions in months, rather than years.
Kenencke: You have to do it as quickly as possible, but you still have to follow all the protocols because there has been a lot of hype around this drug. And the truth is what? We really don’t know for sure?
Dr. Skipper: Yeah, we don’t know. We just don’t know. People want to be optimistic and I want to be optimistic, but that’s why we rely on the process—a process we’ve used for over 100 years now.
Physicians on the front lines treating COVID-19 are waiting for science to tell them what the best course of action may be.
“I’m hopeful we will find something from those trials. Right now the medicines themselves, we don’t have great data that they work. I’m hoping I can say differently here; once the trial is completed,” Avera Hospitalist, Dr. Nathan Miller said.
Read more about the University of Minnesota trial here.
Cleveland Clinic taking part in ORCHID trials