Dr. Grothey: So, let me ask you about the CCC19 effort. What kind of parameters are you trying to record, and what do you think would be an outcome, an endpoint, in the result of this initiative?
Dr. Warner: So, the immediate goal is to learn as much as we can about acute illness in cancer patients with COVID-19. So, most of the survey instrument that we designed is focused on that acute care setting. So, we basically ask a series of questions using a REDCap survey about a patient’s current medical status, what is the state of their COVID-19 diagnosis, because we know that not everywhere is able to test, and test results often take quite a bit of time to come back, so you know, we’re not restricting the survey to people with lab-confirmed COVID-19.
We’re asking a lot of questions about treatments, about medications the patient might be on when they arrive, not just their sort of standard medications, but increasingly people are getting access to unproven, experimental but available therapies such as Plaquenil, so we’re asking about that, and then we’re asking about treatments that might have occurred in the hospital, including experimental drugs.
And then finally, we ask a lot of questions about the cancer, so was the patient on treatment recently, and if so, more details about that. What is the context in which the patient is being treated? Is this a patient who is undergoing therapy for metastatic disease or are they in the middle of an adjuvant course of therapy? So, we’re trying to get all that.
And then we’re starting to build out follow-up questions as well, because we now understand that the majority of people will recover from COVID-19, but it could leave them with lasting damage to the lungs or elsewhere, and it’s probably going to affect their cancer treatment as well for some period of time. So, the plan ultimately here will be to collect data for several months or longer after the acute illness.
Dr. Grothey: Yeah, and as you mentioned before, this is not relevant only for the COVID-19 pandemic, but this data could be used, number one for future pandemics. You know, you never know. This is not going to be the last viral outbreak that we see, we might have actually a second spike next year again. But also, looking at healthcare delivery, the impact overall, and I’m also intrigued by some confounding factors. I guess we talked about immunotherapy, how do patients on PD1 antibodies, for instance, do each with higher lung radiation, bleomycin exposure, all of these things that we know can damage, let’s say create a preexisting condition that might affect the severity of the COVID-19 infection and disease.
One thing that I’d like to ask you is how can community oncologists get patients into the database. Is there anything…do you have to be a member of an institution that’s signed up or how do you do that?
Dr. Warner: That’s a great question, and we designed this survey to be open to any domestic healthcare professionals. So, let me emphasize that: any domestic, which would be the United States and the outlying territories, healthcare professional can enter data into this survey. That’s been determined by the Vanderbilt IRB. It’s exempt, so there’s no patient identifiers in the survey, and so yes, we want to get reports from the community because I think that that’s maybe where quite a lot of perhaps the less severe disease is being seen rather than in hospitals, which are attached to institutions, and I think it’s just as important to learn about relatively mild cases so that we can risk stratify better than to only report on the most severe cases.
So our website, which is currently CCC19us.org, and hopefully in the next few days we will have ccc19.org, but go to the website. There’s a button right there to press to get to the survey. If you only fill out the required elements, the survey should take about two minutes or so. If you go through the more thorough elements, the optional questions, maybe more like five minutes, but you know, the survey is designed to really be completed rapidly and anywhere that you have internet access.
Dr. Grothey: So, how many patients have already been entered into the database right now?
Dr. Warner: So, it’s not a huge number yet. I didn’t check this morning, but it’s probably less than 20, although I will note that the largest study to date out of China had only 18 patients, so it’s already comparable to that. We expect that number to go up quite quickly because the participating institutions, most of them are getting their local IRB approval as well as insuring with their privacy office that the sharing of information, even if it’s de-identified, which is how this is designed. Some institutions have additional rules around sharing of any medical information outside of that institution. So, there might be some red tape to work through.
I’ve got a few requests for data transfer agreements and hopefully our legal team is ready and willing to get through those as quickly as possible. Our IRB has been amazing, very collaborative. They’ve basically taken all COVID-19 projects to the front of their queue and are trying to work with us as quickly but as ethically as possible.