Clinical trial pro bounces back from COVID-19

As a five-year veteran of LMC Manna Research in Canada, clinical research coordinator Andre Valleteau is very familiar with the ins and outs clinical research work. However, after being diagnosed with COVID-19 in March and recovering, he has seen trial life from another point of view—as a patient.

Outsourcing-Pharma (OSP) spoke with (AV) about his unique his career, diagnosis and what he learned through his experience as a COVID-19 trial participant.

OSP: Could you tell us about your career—how long you’ve been in clinical research, how long you’ve been with LMC Manna Research, and what a typical day at work was like for you before COVID-19?​

AV: I started working in clinical research in 2014 because of my undergraduate honour’s thesis – I was researching cell-free DNA in subjects with neurodegenerative diseases such as Alzheimer’s. Following graduation, I landed a position as a Clinical Research Recruiter (CRR) in November 2015 at LMC Manna Research in what I’d consider my first real full-time job.

I have been at LMC Manna since and have worked up to the position of Clinical Research Coordinator II (CRC) over the past 4 and half years. Prior to COVID-19, a typical day would involve completing patient visits and maintaining studies for clinical trials at our research sites.

OSP: Think back to life before your diagnosis—specifically, the time you first heard about coronavirus/COVID-19 in the news, up until right before you were symptomatic, then tested. How did the virus impact your personal life and professional life?​

AV: At the time, COVID-19 was receiving conflicting news reporting and media attention - there certainly was a lot of confusion on how seriously the virus should be taken. There were not many measures globally on restricting travel; no screenings upon arrival, and WHO was releasing contradicting statements as everything was still being figured out.

Eventually, WHO declared COVID-19 a global pandemic on March 11th, whereas I was given a positive diagnosis on March 10th, so life before this was more or less business as usual.   

OSP: Were you scared at all about getting it?​

AV: It wasn’t something that was particularly a main concern, it seemed like an issue that was distant and out of reach at the time. You heard of it on the news but it wasn’t really here yet until it was.

OSP: Did you have any friends, family, coworkers, etc. that had the virus?​

AV: Prior to being diagnosed, there was nobody I knew that had it, this was really new to Canada. I was only the 45th confirmed case in Ontario so it really was early in the COVID-19 timeline.

OSP: When did you hear from Public Health Ontario (PHO) — how did they know you’d been in contact with a positive patient?​

AV: PHO contacted me on Tuesday March 10th to break the bad news. A patient I had seen earlier on Thursday March 5th had returned from the US after attending a conference and was in clinic for a study visit with me.

At that time they were asymptomatic; they developed symptoms over the next few days and received a communication warning that someone with infectious COVID-19 had also attended the conference. Their symptoms were not improving, so they decided to get tested and their result was positive. From there, they had to trace each of their contacts and I was among them.

OSP: After diagnosis, I understand you had to reach out to people you’d been in contact with. What were those conversations like?​

AV: I had quite a number of people to contact and I knew I’d be able to reach them faster than public health would as more and more COVID-19 cases started to arise. With no time to waste, I typically started these conversations with a blunt “So, I have coronavirus”; I was direct and to the point in order to avoid delaying other contacts.

Reactions were, for the most part, “Thanks for letting me know, now what do I do?” There was, of course, concern however I reassured individuals that PHO would be in touch shortly to confirm this and review instructions.

In the meantime, I recommended working from home, self-isolating as a precaution based on the PHO guidelines, and to also prepare a list of recent contacts just in case.

OSP: Specifically, what were your conversations with work folks like?​

AV: I had friends from work that I had been in contact with the weekend prior to being diagnosed and I’d say the news went over fairly well. Everyone took the recommendation seriously and went into self-isolation immediately.  

OSP: We’re glad you had mild symptoms — could you please describe what they felt like, and how you managed them (any pharma treatment, otc or otherwise, or rest/foods/fluids recommended by docs)?​

AV: The main symptoms I experienced were fatigue, headache, and a cough (dry at first, then productive). The fatigue was quite significant and for the first week it didn’t matter how many naps I took or how much I slept throughout the night, I’d still wake up feeling tired.

To counter this, I tried to plan my day ahead and schedule time to cook, eat, be awake, and sleep. This was my way of making sure I was eating properly and consuming the right things in the right amounts for recovery.

Headaches were different than usual too, feeling like a huge ball of pressure was pounding behind my eyeballs. I took acetaminophen for treatment, but it wasn’t really helpful so I just tolerated the headaches until they resolved on their own.

For the cough I was sipping hot tea all day and all night - cold water was a thing of the past for me.

OSP: What was isolation like—what did you do to keep your spirits up?​

AV: Friends from work went into quarantine due to being in contact with me so we formed a group chat and kept each other entertained with games, calls, dares - just a whole lot of chatting and virtual company in general. It ended up being a bonding experience and a sort of support group as we were going through the long days of quarantine together.

My family was also in touch daily and quarantine gave me an opportunity to reach out to old friends that had gotten out of touch over the years. At the end of each day, despite being sick and home alone, there was always a silver lining.

OSP: We’re also glad you’ve since tested negative—what was your reaction to that news?​

AV: It was a massive relief. The PHO guidelines on who could get tested, and if people should be retested for negative results, were being reworked at the time due to supply shortages; this meant that I was waiting for a number of days to find out what the end of my quarantine protocol would be. However I mentally prepared myself to be stuck in isolation for a couple more weeks.

There was definitely fear of the result coming back positive again – what then? I definitely did not enjoy the idea of extending quarantine, but there was nothing more than to be patient at that point.

Next thing I knew, the end of quarantine protocol had been laid out, I had been retested, and my results were negative.  I walked out onto the grass in front of my building in nothing but PJs, socks, and slippers for a breath of freedom – it was great.  

OSP: Happy belated birthday—what was celebrating your 27th in isolation like? Most importantly, do you have any cake left?​

AV: Thank you! Well, as the news headline put it, “Toronto man spends 27th birthday alone with his cat.” In all seriousness, it certainly was a memorable birthday; friends and family had each sent a cake to me and I spent most of the day talking with them and hanging out with my cat Pepper.

For the aftermath, let’s just say the cake-sized space in my fridge is now vacant until next year.

OSP: How did you come to learn about the trial—I understand you actually reached out to your doctor?​

AV: That’s right – I couldn’t find anything online through general searches or clinicaltrials.gov and figured the best person to ask was Dr. Adrienne Chan who was following my case remotely from Sunnybrook.  She then inquired amongst her peers and connected me with Dr. Mario Ostrowski, a researcher from St. Michael’s Hospital.

OSP: Could you please describe the trial?​

AV: The study is very straightforward for participants – it involves a single visit and the participant undergoes leukapheresis which is simply an extended blood draw that selectively extracts your white blood cells. These cells can then be studied in the lab to better understand the immune response to COVID-19, potentially identifying vaccine candidates.

OSP: How were you enrolled?​

AV: I spoke with Dr. Ostrowski over the phone to discuss the trial and what would be involved. He had provided me with the consent form, and ample time to review it. From there we just had to wait until my quarantine was complete so that I could visit St. Michael’s for the procedure.

OSP: What was participation like—was it onsite, decentralized or hybrid?​

AV: This was onsite - leukapheresis requires a specific medical device to selectively draw white blood cells from the rest of the blood contents.

OSP: Did you learn anything about trials in general from that side that you didn’t know or realize before?​

AV: I always tend to observe how people conduct their trial visits and interact with study participants. The nurses that were involved in the procedure were excellent and such professionals at making sure patients felt comfortable; I hope to develop rapport with my patients just as easily as they were able to.

OSP: Have you had any follow-up or invitations to participate in other studies?​

There have been multiple trials since:

• NeuroCovid (Sunnybrook): Studying COVID-19 and its effects on the brain, cognitive ability, and olfactory senses. It involves two visits that are three months apart, consisting of a brain and chest MRI, plus a series of cognitive and olfactory tests. I’m halfway through this.
• CONCOR-1 (through Canadian blood services): It is a country-wide convalescent plasma study looking at using plasma from recovered patients and providing it to more severe cases of COVID-19 patients – so studying if patients are able to use antibodies from recovered subjects to fight off their infection. My first donation is done and I’m waiting on confirmation to continue for the second round.
• COVIDFree@home (Sunnybrook): I’m acting as a collaborator rather than a subject for this trial. We’re working on an app that will track the symptoms of patients that have COVID-19 and are self-isolating at home. Based on symptoms & progression, we are seeing if we can we predict who would require more intensive care with hospitalization, hoping to avoid the risk of a rapid decline to a critical state.