A COVID Trial Pitches a Tent in the Great Outdoors
When you think of advanced clinical trials, you usually don’t think of a tent. But that’s where you’d be wrong—in April 2020, when COVID felt new and every breath was terrifying, a tent was just what the doctor ordered.
Why Not in California?
The idea came to the team very early in the pandemic—so early, in fact, that Upi Singh, MD, division chief and professor of infectious diseases, remembers that it was before social distancing, when a group of doctors including herself and Julie Parsonnet, MD, George DeForest Barnett professor of medicine, started to think outside the box.
Jason Andrews, MD, associate professor of infectious diseases; Bonnie Maldonado, MD, senior associate dean of faculty development and diversity, and Taube professor of global health and infectious diseases; Prasanna Jagannathan, MD, assistant professor of infectious diseases; and Hector Bonilla, MD, clinical associate professor of infectious diseases, were also quickly made part of the team.
Like many others, they realized that COVID trials would need to be set up quickly and that outpatient trials would be ideal because they enable doctors to see and treat patients in a low-touch environment. They decided on a clinical and translational research unit (CTRU) and ended up with the idea for a tent.
As Maldonado explains, some tents had already been set up for COVID testing and were about to be decommissioned, so repurposing them made a lot of sense. “We thought they’d be suitable and safe,” she says.
“Bringing people to the hospital to do COVID research was almost taboo. There was too much anxiety around it back then,” Singh adds. “We were seeing some of the drive-through tents in various places around the country, so we thought, well, why not? We live in California, it's good weather, we could do it here.”
Turning an Idea Into Reality
Chaitan Khosla, PhD, Wells H. Rauser and Harold M. Petiprin professor of chemical engineering and chemistry, as well as director of the Innovative Medicines Accelerator (IMA), was brought in early too. The IMA, an initiative born out of the long-range-planning mission at Stanford, seeks to help turn research ideas into actual real-world drug trials or programs by, among other things, helping to fund promising early-stage research and form alliances with biotechnology and pharmaceutical companies, governments, and nongovernmental organizations to exchange knowledge and expertise.
In this case, “This was an obvious thing for us to support,” Khosla says. His role was to help with fundraising and operational aspects and to “understand how to bring the vision of the IMA to reality in the context of a disease that occurred after the IMA was created.” And that reality had to happen quickly.
The team talked to leadership, administration, the CTRU, and the people at the IMA, as well as writing to donors for funds, and in a matter of weeks, the tent was up. The idea was raised at the end of March, and April 25, “a sunny Saturday,” Singh remembers, was the first day in the tent.
COVID team members at work in the tent
The CTRU tent under a beautiful sky
Jagannathan was co-principal investigator (PI) of the first trial, the peginterferon lambda, with Singh, and remembers the fast growth of the idea. “Within a few days after the shelter in place began, we began work on the study,” he remembers. “We started as a small group of investigators—Upi, Julie Parsonnet, Jason Andrews, myself—but grew our team rapidly (with almost daily Zoom calls that went into the wee hours of the night).”
Andrews agrees: “In hindsight, it was remarkable how fast things came together! At that time, clinical trials among inpatients were underway, but there was no attention towards the needs of patients who were not yet hospitalized (which at the time comprised about 90% of all COVID patients).” The questions, he says, were: “Could we treat them early, avert serious disease and complications, and prevent hospitalizations? Could we reduce risk of transmission to their families? Everyone was understandably focused on inpatients, but this was the proverbial tip of the iceberg. So we went to work and initiated some of the first outpatient clinical trials for COVID in the country.”
The Early Days
During the tent’s run from April 2020 to January 2021, it hosted six trials for COVID treatment, including peginterferon lambda, camostat, favipiravir, and multiple Regeneron monoclonal antibody trials. The early days were particularly challenging.
For one thing, even just setting up the tent involved a lot of teamwork and creative thinking, not to mention just plain old getting your hands dirty. In the early days, there wasn’t even furniture. Singh bought chairs on Amazon and put them together with fellow faculty and staff members, which she found to be a surprising bonding experience.
“I’m a pretty engaged faculty member,” she says, “but you get to know people differently in a situation like the tent. You’re not just sitting in meetings and having intellectual discussions. You’re seeing who will come help you put chairs together, and you’re having a cup of coffee outdoors when COVID is there and everyone’s scared. You learn about people in a different way.”
Team Treat COVID staff
Parsonnet agrees. “It could be cold sometimes in the tent, and it could be wet and rainy and windy, but it felt like we had this great team—the subjects and the research staff together working to bring something good out of the pandemic. It was innovative, interesting, and exciting; we were out at the forefront.”
Singh likened it to a start-up—at first, the CEO does everything. In the early days, she would get the drug, draw blood, label tubes for the trial, and even recruit patients. She managed the trials and the project while also managing her other work as division chief and her various other projects, including her lab. And team members often worked seven days a week, including the many staff members from the Stanford Center for Clinical Research Center: clinical research coordinators, nurses, lab staff, phlebotomists, and countless others
Singh had never worked like this before. “I’d never done a clinical trial. I’m a basic science parasitologist, I’m not a virologist. I hadn’t done any of that. So,” she laughs, “it was a little unusual.”
Outdoors in a Pandemic
The team faced numerous challenges. For one thing, the administrative and operational work was very difficult. “We were trying to set up a CTRU that could support multiple faculties’ goals and be operated and deployed with the resources of the CTRU in a fair, democratic manner,” Khosla describes, “while also promoting the best possible science. Trying to deliver on the enormous value of what was being envisioned was my biggest challenge.”
For Jagannathan, “One of the biggest challenges of working in that setting was the unknown, the risk we were putting ourselves and our study staff in and the risks we were putting our families in at home.”
Keeping up morale in the tent with Team Treat COVID
In addition, there were challenges with patients. The patients (120 in total for some early trials) had to visit the tent nine times each during the course of the trials, and they were given the drug on the first visit, so there were concerns that they wouldn’t show up again. But they did, to everyone’s relief—the tent’s trials had a 95% retention rate. Over the last year, the team handled more than 3,000 patient visits in the COVID CTRU.
Yet another issue was the weather. There were brutally hot days in the summer, when it was over 100 degrees in the tent, making things difficult for everyone, particularly staff and doctors in full personal protective equipment. During October, Northern California wildfires made the air quality so bad that the tent had to be shut down. For a period of three weeks, Singh remembers, she was checking the air quality website PurpleAir first thing in the morning, and sometimes patient appointments were canceled or the whole operation was moved indoors to the CROWN clinic.
And then, of course, there was the obvious fear of COVID infection. Patients were anxious, and often very ill, and the staff were scared too. One of the nursing staff later confided in Singh that he was convinced he would get COVID at some point from working in the tent, but he figured he was young and he’d be OK.
But that story had a happy ending: There were zero COVID transmissions in the tent. It was a successful experiment in many ways. “We had the first outpatient clinical trials site in the United States, I believe,” Parsonnet says.
Singh agrees: “We were able to show that we could do really high-quality science at the beginning of a pandemic. I presented the idea and the concept at a national infectious diseases meeting in October 2020, and people were shocked that we had already completed an outpatient clinical trial for COVID-19 and that we had been able to do it so quickly.”
A Team Effort
All the members of the team emphasize that across the board, this was a team effort. The tent hosted anywhere from to four to 10 team members at a time, but there were numbers of people in administration and staff working behind the scenes.
And no one wants to forget the patients’ contributions, either. “I knew that patients were upset and scared, but we would enroll somebody in a trial, and we would see them every other day for a month or nine times in the next three weeks,” Singh says. “You got to know them. And they were nervous. Try to remember back to April and May of 2020. Very few people had COVID; people didn’t really know what to do. And patients were so appreciative that we were there, smiling, that we were happy to see them. And we were grateful that they didn’t cancel their visits, and we were there to take care of them. It reminded me why I went to medical school.”
“People who are involved in clinical trials are often really motivated by doing good for the world. These people who join these clinical trials are heroes"
Parsonnet agrees: “People who are involved in clinical trials are often really motivated by doing good for the world. These people who join these clinical trials are heroes. They’re doing something that’s a little risky when they’re not feeling well. And remember, these are randomized trials, so they know there’s a 50% chance they’re getting nothing. And they do it anyway. The altruism of all involved made for a really cohesive, wonderful community between the patients and the staff.”
“To me, it’s all about people,” Singh concludes. “The leadership supported us, the people we included who were doing the work worked hard, and then people were just open-minded and innovative.” And the army of staff members carrying out research duties and trial tasks were, as Singh remembers, “the real backbone of the work in the tent.”
In fact, those staff continue to be crucial. Since the tent’s closure in January 2021, the trials have moved from the tent in the Galvez parking lot to the modulars, where a larger clinical research staff is continuing the crucial COVID treatment trials.
Jagannathan was amazed by “how impressive, collegial, and committed our study staff and volunteer physicians were. We would have long days in the tent and then ask our teams to join study calls multiple times a week, going from 7 p.m. until 10 p.m. or later at night. Everyone would participate to get the study off the ground and make sure that we were conducting the study with integrity.”
Matching jackets for Team TreatCOVID, Clinical Trials Research Unit
“Everybody understood that this was a moment that was not about ourselves,” Khosla states. “It was essentially a calling. They weren’t doing it to promote their own careers or to feather their own nests. There was a real altruism associated with this whole initiative. I think sometimes you have to be in the depths of a really miserable situation to see people have such noble goals.”
Bonilla was full of praise for each member of the team, calling Singh “the mayor of the village” and citing others’ “warm personalities, great knowledge,” and “incredible support.” “We became a real family,” he adds. “I have never been so happy doing this kind of job.”
“It really was an impressive organizational effort that involved a lot of different people with a variety of talents,” Parsonnet says. She remembers the early days of the tent almost fondly: “It gave us a wonderful feeling of doing something transformative and doing something as a community.”
And Maldonado echoes, “The camaraderie that developed among staff, faculty, and most importantly our participants was surprising and rewarding. We’ve all been in this together!”
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Working in the Tent
Jason Andrews, who has worked on many global health initiatives, from a renovated grain shed in Nepal to a renovated truck in Brazil, was a little more familiar with nontraditional medical environments. But, he adds, “it was exciting to find creative ways to extend access to these investigational treatments for COVID to patients who otherwise might not have options.”
He worked regularly in the tent, as well as serving as a co-investigator on several of the studies and principal or co-principal investigator on others, and found the experience invigorating. “There was a real esprit de corps among the CTRU team, particularly in the earliest days,” he remembers. “There was a strong can-do spirit, with all of us finding solutions to overcome obstacles and fulfill our commitment to the patients. It was really fulfilling to be part of a team that was so focused and committed.”
Prasanna Jagannathan also worked regularly in the tent and was familiar with clinical trials (although not in this particular setting.) “As the saying goes,” he says, “in the lambda study, we built the plane (tent) as we flew (occupied) it.” He was part of the early group of staff who worked seven days a week during the tent’s early days, and also served as a co-PI on the first study.
Bonnie Maldonado was no stranger to unique clinical trials, having set them up in small villages in Veracruz and in the highlands of Chiapas, Mexico, among Indigenous Nahuatl and Mayan populations, among many others, but she agrees that there were distinct challenges involved in this work. “Very early on, most of the work was actually being done by our infectious diseases faculty,” Maldonado remembers, “seven days a week, on top of their routine clinical, teaching, and research responsibilities. The biggest challenge so far has been trying to build new programs and clinical trials de novo, from identifying a novel therapeutic to understanding the construction and equipment needed to maintain the COVID CTRU tent and buildings.”
She took her turn as the PI of one of the studies and co-PI of others, working weekly in the tent to enroll and attend patients, and has now moved on to thinking about how to build new strategies for therapeutic studies.
Julie Parsonnet also helped recruit, monitor, and treat patients. She is the PI for the camostat trial and helped design and implement the lambda trials (not to mention her other projects and duties).
Hector Bonilla, who was part of the original team voting for the tent and its location, was invited to be part of the first outpatient trial of lambda. He remembers that the tent “became our second home” and calls the work “the opportunity of a lifetime.” He worked nights (recruiting mainly Spanish speakers for the trial) as well as days (enrolling patients, collecting samples, drawing blood, and answering patient questions, among many other duties). He remembers colleagues doing the same, sharpening their Spanish as the trial went along. “It was a real village,” he concludes, remembering how the work and interactions with colleagues made him “feel proud and respected by each division member.”
Chaitan Khosla, who worked mostly offsite, was “in complete awe of the clinical team in the tent,” he says. “And not just the doctors but also the clinical staff over there—the nurses, the clinical research coordinators, and the other support staff.”
“There is no way we could have done any of this without the staff,” Upi Singh agrees. “They also took a chance early on in the pandemic, trusting that they would be safe. And they very quickly became addicted to the positive impact of the work and the connections with patients.”