by Bill Snyder
The development of the vaccines, monoclonal antibodies and antiviral drugs that ultimately will defeat COVID-19 wouldn’t have been possible had it not been for the unflagging and selfless efforts of a global army of research nurses, laboratory personnel, recruiters and other staff.
At Vanderbilt University Medical Center, these coronavirus crusaders work in the Clinical Research Center (CRC), the Vanderbilt Vaccine Research Program (VVRP), the Vanderbilt HIV Vaccine Clinical Research site (VV-CRS) and the Vanderbilt Therapeutics Clinical Research Site (VTCRS).
Without them, the scientists who lead COVID-19 research at VUMC could not have completed the clinical trials necessary to help prove the safety and effectiveness of the antiviral drug remdesivir or the vaccines being readied for mass distribution by Pfizer and Moderna.
“These front-line translational research workers are moving the needle on therapeutics for this disease,” said CRC Director Kevin Niswender, MD, PhD, associate professor of Medicine and of Molecular Physiology & Biophysics. “They’re knockin’ it out of the park.
“It’s not been without substantial stress and some anxiety,” Niswender added, “but they have really stood up and delivered in ways that should make all of us extremely proud.”
This spring VTCRS Research Manager Beverly Woodward, MSN, RN, logged 100 days straight working without a break, including Saturdays and Sundays. “I hit another, 90-day period recently,” she said. “It’s pretty wild, all day, every day. But it’s worth it, and it’s important.”
As part of the national ACTIV-2 program (Accelerating COVID-19 Therapeutic Interventions and Vaccines), Woodward’s team conducted a clinical trial of bamlanivimab, an investigational monoclonal antibody given by intravenous infusion to outpatients with mild to moderate symptoms of COVID-19 to reduce their risk developing severe disease or requiring hospital care.
Last month, after bamlanivimab was approved for emergency use by the U.S. Food and Drug Administration, Woodward’s father texted her from Texas: “I want to thank you. I already know two people who were treated with that drug.”
“For our CRC team, it has been most gratifying to see such positive and rapid results from these studies,” said CRC Nurse Manager Lana Howard, RN, CCRP. But to get there, “we had to work in new ways … and do it quickly,” she said.
Clinical trials involving patients infected with COVID-19, for example, are conducted in the CRC’s Communicable Disease Response Unit, which includes state-of-the-art ventilation and negative pressure systems, separate patient entrances and an area for clinicians and researchers to put on and remove personal protective equipment.
As managers, “none of us would ask our staff to do what we wouldn’t be willing to do,” Howard said. “I think they know that about us, that we’re right there beside them doing the hard things.”
“I have never been so thankful for my team,” Woodward agreed. “We’ve learned together … We did things no one’s done before … but we figured out a way to do it.”
The COVID-19 vaccine trials have been equally intense.
“Since the beginning of June, I probably haven’t had a work week that has been less than 70 hours,” said Kyle Rybczyk, MSN, RN, research coordinator of the Moderna vaccine trial’s “blue team,” which is run through the VV-CRS, part of the national COVID-19 Prevention Network.
“I’m so tired all the time,” said Rybczyk, who also is a family nurse practitioner in the Vanderbilt Infectious Disease Clinic. “Every day is a day of aggressively going after the next pieces of data so that we can eventually help the world.
“I’ve had friends who have ended up in the hospital,” he said. “I’ve had friends who have died from COVID. Seeing all this struggle around me on every level makes me think, ‘OK, I need to keep trying to fix it, and to do what I can make things better.’”
“We have worked tirelessly, lost precious time with our loved ones, and given up so much to make sure our volunteers were taken care of and our teammates stood strong during such trying times,” said Shanda Hand Phillips, RN, CCRP, research projects manager of the VVRP and the Moderna trial’s “orange team.”
“It truly was a massive team effort,” Phillips said. “I keep saying ‘team,’ but we are more of a family.”
At first “I was extremely stressed,” added VV-CRS Lab Manager Rita Smith. “We were all working long hours and coming in on weekends to get people enrolled. But the impact that this virus has had on people’s lives has made me want to work harder.”
Smith is among dozens of VUMC researchers who formerly focused exclusively on HIV, the human immunodeficiency virus. Once COVID-19 arrived, however, their expertise in conducting clinical trials of potential therapies and vaccines against HIV was now needed to help combat another deadly pandemic.
“We have HIV and COVID prevention studies happening currently at our site,” said VV-CRS Research Manager Shonda Sumner, RN. “I am blessed to work with such a dedicated and caring team.”
“It’s my team that keeps me going,” Phillips agreed. “It’s a huge undertaking, doing all these studies. I feel a great responsibility to my team, and I don’t want to let them down.”
Nor do they want to let their study volunteers down.
Those who volunteer for studies of investigational therapeutics, like the monoclonal antibodies, “have to be symptomatic, to be at the very early onset of (COVID-19) symptoms,” Woodward said. “They feel terrible and they’re scared.
“What we do is never possible without people who are willing to donate their time and their blood,” she said. “They’re just incredible.”
Other non-medical/faculty COVID-19 research team members are listed below.
Vanderbilt HIV Vaccine Clinical Research site: Jarissa Greenard; Amber Massey, RN; and Keith Richardson.
Vanderbilt Therapeutics Clinical Research Site: Becky Basham; Heather Burgess; Latifa DaSilva; Huso Erdem; Joan Gottesman, RN; Brenda Jackson, RN; Michael Leonard; Morgan Lima, RN; Vickie Myers; Fred Nicotera; and Tracey Watkins, LPN.
Vanderbilt Vaccine Research Program: Robert Adkisson, RN; Eric Brady; Matt Donio, PharmD; Anna Gallion, DNP, APRN; April Hanlatxanphou; Naomi Kown, MSN; Shelly McGehee, MBA; Deborah Myers; Katherine Sokolow, MSN, RN, CPNP-PC; Cindy Trimmer; Roberta Winfrey; Wendy Winn; Katherine Wright; and Sandy Yoder, MT.
Clinical Research Center COVID Team: Kisha Batey Turner, medical lab scientist; Lamar Bowman, RN; Sherri Hails, RN; Linda Kinnard; Daryl Lawrence; Deloris Lee, RN, CCRP; Melissa Lehman, RN, CCRP; Becky Miller, MSN, RN; Robin Perkins, RN; Crystal Rice, RN; and Krissi Woehler, MSN, RN.
CRC Vaccine Team: Diane Anders, BS, ADN, RN; and Connie Dotye, RN.
CRC Research Staff: Stella Bosah, RN; Tilla Crawford, RN; Sandra Fitzgerald, RN; Stacy Gilbert, RN; JoAnn Gottlieb, RDMS, RDCS; Danielle Harris; Kimberly Hickman; Millicent Johnson, MSN, RN; Tinu Kassim, MSN, RN; Trina Montgomery, RN; Venny Mkoma, CNA; Betsy Parker, ADN, RN; Bianca Plunkett, RN; Ben Small, MSN, RN; Kim Slicker; and Tim Smith, RN.
