By Alec Pruchnicki, MD
Northwell Health Systems sent out press releases recently, concerning research they are doing to combat COVID. Before I discuss these projects, along with a few suggestions of my own, let me describe some of the issues involving medical research.
All ethical research must be approved by an Institutional Review Board (IRB) to see that all legal and ethical standards are met. These boards usually include physicians, researchers, administrators, ethicists, lawyers and, often, members of the public among others. Standards they use are usually a combination of federal and state laws, regulations by the funders (either private foundations or government agencies) and policies at the institution. Once approved by the IRB, and funded, the researchers often have to get access to medical records or medical laboratory specimens. This sometimes requires permission from the affected patients or their families.
When human subjects are involved (animal studies require separate policies), for clinical trials, they must be recruited. This is often difficult as it is necessary to find patients who are willing to participate, sometimes only in the placebo or untreated group, and who meet the criteria for the type of patients required for a given study. An extensive system such as Northwell can do this. Large numbers of patients, families, and the general public who are involved with or familiar with Northwell facilities are potential recruits.
As for the specific projects, Northwell has publicized a few. One would study patients who have had COVID and recovered. Their plasma, the clear fluid extracted from blood, should contain antibodies to the COVID virus since that is the presumed way these patients survived. If this is transfused into other people recently infected with COVID, would it help them fight or resist the worst aspects of the disease? The strength of Northwell, and the other hospitals it is working with, is that they might have extensive medical records along with the laboratory samples from patients who might be able to donate plasma.
Another project involves an anti-viral drug called Remdesivir, which has been shown in laboratory studies to have some potential ability to fight other deadly corona family viruses like SARS and MERS. Clinical trials are recruiting patients for this study and a large organization like Northwell can help.
Lastly, a medication called Sarilumab is being investigated as a possible inhibitor of the inflammation reaction that produces some of the lethal symptoms of COVID. Inflammation can shut down many organ systems, including the lungs, and controlling it could lessen the intensity and consequences of the infection.
As a former researcher, I couldn’t help but start thinking about new projects. The use of chloroquine as a treatment for COVID has been touted by numerous anecdotal accounts, the internet, and even President Trump. But some people already take chloroquine or one of its derivatives for malaria prevention, lupus, or rheumatoid arthritis. There must be some patients within the Northwell system who are taking it. Do they get COVID as easily as others? If infected, do they get symptoms, or die, more or less than others? The medical records might be sitting in Northwell computers right now, along with blood samples in laboratory freezers.
As noteworthy as Northwell is, it can’t be the only hospital system in New York doing COVID research. If you have any interest in helping out, possibly as a subject in a clinical trial, contact your doctor or hospital and ask if there are any studies that might need your help. And remember, when testing starts for a vaccine there will be many studies which absolutely have to be done to ensure safety and efficacy. Get ready to sign up. I will. (Disclaimer: I am not employed by Northwell or any of its branches.)
