Clinical Research Services Staff Deployed to Meet the Moment

UCSF holds drive-through screenings at various locations in the Bay Area. Photo by Barabara Ries.

As the majority of UCSF research studies had to ramp down in the early and peak stages of the shelter-in-place order due to the Coronovirus pandemic, the Clinical and Translational Science Institute’s Clinical Research Services (CRS) program redeployed various staff whose skill set could support COVID-19 research, as well as other critical frontline work during this time.

 

Several CRS program staff report from the ground on how they have shifted their charge over the past few months. Efforts ranged from conducting health screenings at various UCSF Health clinical locations to supporting drug trials for COVID-19 and antibody research. Read below to learn more.

 

Remdesivir & Other COVID-19 Drug Trials

Sara Brickman, RN, Clinical Research Nurse -  CRS ZSFGH

Jay Dwyer, RN, Ambulatory Care Patient Manager 
 

Dwyer comments: "Remdesivir (RDV) is an anti-viral drug being investigated as one of the most potent ways to treat COVID-19. Sara Brickman, RN, clinical nurse, has been diverted from CRS to support frontline staff by helping with inpatient treatment trials. She has been invaluable with consenting participants or their legally authorized representatives; enrolling participants and ensuring randomized treatment assignments get to the inpatient pharmacy quickly; providing nursing education to ICU and floor nurses about Remdesivir and now Baricitnib (anti-inflammatory drug also being investigated to treat COVID-19); delivering specimen collection kits to the medical surgery unit and ICU at ZSFGH and coordinating specimen delivery from the floor to the core immunology laboratory. She has been extremely helpful in helping the site process data to include standard data entry but primarily focusing on adverse event, serious adverse event, and reporting endless lists of all concomitant medications while participants are enrolled to include indication for the medication. Our non-clinical staff is struggling a great deal with this aspect of data reporting.

 

We continue to enroll in the RDV trials. The initial trial was classified as ACTT 1 (Adaptive COVID-19 Treatment Trial) and demonstrated remdesivir had activity against this novel SARS virus reducing hospitalization times and improving recovery time. ACTT 2 launched two weeks ago and we evaluating combination therapy. This protocol is written to be adaptive, so we assume there will be ACTT 3 and beyond as we narrow our treatment protocols.  We have additional studies opening up as well exploring the use of canakinamab in hospitalized patients to see if this monoclonal antibody may help reduce progression to Acute Respiratory Distress Syndrome (ARDS). We also will continue to evaluate hydroxychloroquine with or without azithromycin both in and outpatient. There also is actively a rich pipeline of other protocols being explored."

 

CATCH RN Program - COVID Assessment, Testing, and Coordination Hub
Patricia Cannon, RN,
Clinical Research Nurse – CRS Parnassus
 

"I have been redeployed into a pilot program called CATCH - this stands for COVID Assessment, Testing, and Coordination Hub. The purpose of this team is to do the screening, test ordering, referral and tracking process of COVID testing, reduce defects in the process, and reduce the burden in the ambulatory clinics of this additional work due to COVID. I am so grateful to be part of this pilot because its purpose is to keep patients safe while enabling them to have their much-needed surgeries and procedures. I have never been part of a pilot of any kind and anything in its pioneering stages – there is a steep learning curve along with a deep but exhausted satisfaction that one is involved in something that can theoretically make a huge difference to patient care at UCSF."

 

Patient Navigation

Lilliete Najarro, Hospital Assistant – CRS Parnassus & SFVAMC
 

"My role went from working as a phlebotomist at the VA and at Parnassus to doing zoom support from home and blood draw from non-COVID patients’ vehicles for COVID-19 testing. One of the challenges was having the necessary equipment such as a laptop and set up at home to be able to connect with the patients. I had not done phone support in over 20 years and assisted the patients with navigating zoom for their video visits. I find that UCSF patients are quite kind on the phone - regardless of whether or not they need assistance. I also work at Laurel Heights doing mobile COVID-19 testing blood draws. It was slightly challenging doing the draws from patients’ cars since I had never done that before, but we make it happen. I am extremely grateful that UCSF has been able to accommodate me by providing such opportunity in such challenging times."  

 

CRS Sample Processing Labs & Biobanking 

Ronald Honrada, Interim Sample Processing Lab (SPL) Manager & Lab Supervisor – Parnassus, ZSFG, SFVAMC
 

"The CRS Sample Processing Lab is partnering with Sanguine Biosciences in biobanking serum from subjects who have recently recovered from COVID-19. The COVID-19 biobank is part of a growing number of investigations by researchers to better understand antibodies associated with the coronavirus. It’s thought that the antibodies produced by the immune system after being infected can provide the key to finding a novel vaccine or therapeutic drug. The idea is to not only create tests to detect who has had the virus, but also develop drugs to treat those who are sick.

 

Additionally, the CRS SPL is partnering with Sanguine in providing isolated peripheral blood mononuclear cells (PBMCs) and serum for a translational study that also involves subjects who have recovered from a COVID-19 infection. These specimens will be used in the search for a novel vaccine." 

 

COVID Screening & CATCH RN Program 

Lorna Beccaria, RN, Clinical Research Nurse at Unit 5B at ZSFGH
 

"UCSF-wide, nurses were given redeployment opportunities so they could still work within UCSF during the pandemic. Elective procedures were put on hold and our particular research unit could only stay open for essential patients. Since many of our patients are all healthy volunteers, they were deemed non-essential. For example, we have vaping studies, smoking studies, cannabis studies – most of these studies have been put on hold. We went from operating five days a week, to two or three to one day a week since late March. We became eligible to enter a temporary UCSF workforce pool.

 

For the first four to five weeks I was redeployed as a nurse screener for COVID-19 at the Mount Zion campus then later at the Children’s hospital at the Gateway Building in Mission Bay. I had screened staff, vendors, patients, which includes children and parents. Some questions we asked include whether people had tested positive for COVID, been in contact with anyone who had it, symptoms in the past 24 hours, etc. If there were any positive answers the patient would get escalated to a respiratory screening (some exceptions could be an oncology patient spiking a low-grade temperature). At the hospital we screened all of our vendors even to make a delivery and teams of construction workers every day. UCSF employees could enter showing their validation on their smartphone after taking an online screening. At the children’s and adult hospitals, we would rotate screenings at the expedited employee entrance, loading docks and at Mount Zion at the oncology entrance. CRS staff Lenneth Balmes, RN, and Leanne Chong, HA & phlebotomist, also did screenings at Mission Bay.

 

That led to another opportunity that I am currently working with called CATCH RN, which has nurses working together from a variety of backgrounds like radiology, infertility, the heart clinic, inpatient, outpatient nurses, etc.

 

As UCSF brings its elective programs back up and gets patients back into the hospital system, we are providing COVID screening for all patients and contacting them three to four days before their procedures. The infectious diseases department and clinic system determine procedures that require screening. We started out with adult pulmonary function tests, some sleep studies, and cardiac procedures. Patients are sent a message in MyChart (UCSF patient portal) to complete their screening and if they are not able to, they are filtered down to a workflow with us and we contact them. There are occasional patients with positive symptoms that get worked up to a different workflow.

 

Unit 5B at ZSFGH will be open for research for two days a week for the month of June. The CRS nurses are rotating shifts to cover these two days.

 

It really is wonderful that UCSF is able to keep all of us without having to lay off people. It’s tremendous that they were able to utilize the talent pool here and redeploy us to areas that help the greater UCSF – we were valued for the work we were doing. It was really nice to work with a variety of nurses that I hadn’t intersected with before as a team with our varying backgrounds, making sure our staff and patients had a safe experience while they had or working on an essential service."

 

Incidence and Seroprevalence of the Novel Coronavirus in the Bay Area
Josephine Liu, Nurse Manager, CRS Parnassus
Danielle Gonzales & Lilliete Najarro – Hospital Assistants CRS Parnassus & SFVAMC


CRS team members Josephine Liu, RN (CRS Parnassus), Danielle Gonzales & Lilliete Najarro (Hospital Assistants, CRS Parnassus & SFVAMC) have shifted gears to work with Hannah Sample (Project Manager, Chan Zuckerberg Initiative) on a research study supported by the Chan Zuckerberg Initiative. This study focuses on understanding the rate at which individuals are becoming infected with (incidence) or have immunity to (prevalence) SARS-CoV-2 in the Bay Area population.The study population is made of the general population (age > 5) and healthcare workers residing Santa Clara, San Mateo, Alameda, Marin, Contra Costa and San Francisco Counties. The main objectives include: 1) To understand the effectiveness and durability of SARS-CoV-2 immunity; 2) To estimate effective viral population size by sequencing SARS-CoV-2 genomes from positive study participants; 3) To provide real-time study results to inform policy makers regarding containment initiatives.