COVID-19 Clinical Trials

During the COVID-19 pandemic, Saint John’s Cancer Institute pivoted its research infrastructure to support COVID-19 clinical and translational research. Today we operate COVID-19 clinical trials, COVID-19 specimen and clinical data collection protocols for collaborations, and COVID-19 translational research projects.

Transition to Biorepository

The bio-repository program at the Saint John’s Cancer Institute has rapidly expanded to meet the challenges of the novel COVID-19 virus. Having vast experience with oncology bio-repositories for research purposes, the team was able to accommodate the growing need for collecting COVID-19 research samples. Since the pandemic began, the program has successfully enrolled over 150 participants and collected ~350 biological samples for research studies across all COVID-19 stages ranging from asymptomatic patients to those in critical care. Moreover, we have been actively collecting samples from current ongoing clinical trials at Providence Saint John Health Center and Saint John’s Cancer Institute. Accompanying these samples, a database was developed by a joint effort of research physicians and database abstractors to identify and document key areas of interest. The combination of comprehensive daily clinical data and specimens has led itself to promising and widespread translational research both here at Saint John’s Cancer Institute and in collaborations with outside researchers.

The Saint John’s Cancer Institute has a long-standing history of performing high quality and impactful translational research. Our Department of Translational Molecular Medicine is actively analyzing samples to identify molecular indicators that can stratify patients based on blood circulating biomarkers and identify those patients that are prone to develop severe/critical COVID-19 disease. Utilizing our comprehensive bio-repository database, we retrospectively searched for clinical characteristics to determine associations with specific molecular profiles obtained from lab results. This information is critical to classify patients and identify patterns of susceptibility to developing severe disease and consequently, decide on treatment options.

COVID-19 has been at the forefront of research for the last year, not only here at Providence Saint John Health Center and Saint John’s Cancer Institute, but at other institutions. Because of this, we have embraced a collaborative approach to our bio-repository collections to work with highly specialized research teams from multiple departments at the National Health Institute (NIH), including the Institute for Diabetes and Digestive and Kidney diseases, National Institute of Allergy and Infectious Diseases, as well as other west coast research institutions such as the Institute for Systems Biology. These collaborations rapidly accelerate medical science as they provide to research teams with access to samples that would otherwise be unattainable.

Ongoing Translation Research at Saint John’s Cancer Institute

1. “Development of Anti-SARS-CoV-2 Inhibitors derived from natural products for COVID-19 treatment”, led by Dr. Venkata Yenugonda
2. “Detection of Circulating Nucleic Acids Signature Patterns in Blood to Identify COVID-19 Progression”, led by Dr. Dave Hoon.

Active COVID-19 Clinical Trials at Saint John’s Health Center

1. A Phase 1 Study of agenT-797 to Treat Moderate to Severe Acute

  • One of only THREE centers in the U.S. selected to run this novel approach to treating moderate to severe patients with COVID-19. This treatment uses a specific type of immune cell to halt the progression of the infection and reverse some of the long-term consequences COVID-19 may cause.

2. Respiratory Syndrome in COVID-19 Patients Analysis of Immune and Organ System Responses in Patients with COVID-19 (InCoV) Study: Latinx Study Extension

  • This study focuses on the Latinx community to prospectively collect biospecimens to analyze the complex immune system perturbations that occur with COVID-19 infections. We are collaborating with our Providence colleagues at Institute for Systems Biology.

3. Saint John’s Cancer Institute Biospecimen & Research Data Repository

  • The biorepository has allowed us to collaborate with the National Institutes of Health on two ongoing projects:
    • Genetic Sequencing of 2019-nCoV To Assist in the Prevention, Detection, Preparation for and Response to its Spread or Transmission
    • The Spectrum and Frequency of Endocrine Abnormalities in COVID-19
      o We built an expansive data and specimen repository to collect information on patients with COVID-19. This repository has enrolled over 150 patients, many of which have been on multiple the therapeutic modalities and ECMO therapy. Below are two articles on this work.
      • “Integrated analysis of plasma and immune cell metabolic changes reveals diverse reprogramming of heterogeneous immune cells in COVID-19”
        • Nature Biotechnology, In press, 2021.
      • “Multi-omic assessment of post-acute COVID-19 sequelae”
        • submitted to Science

4. Stem Cell Therapy

We know that lung injury is one of the most critical issue with COVID-19. Saint John’s Cancer Institute / Pacific Neuroscience Institute (SJCI/PNI ) has a long history of using stem cells to repair the brain in stroke, traumatic brain injury and dementia and we are pivoting this expertise to help COVID-19 lung injury. These same stem cells can repair injured tissue by reducing inflammation, viral load and facilitate healing.

Upcoming COVID-19 Trials and Treatments at Saint John’s Health Center

While we are busy with our current research, we are actively working on next steps with Saint John’s Cancer Institute (SJCI) scientists evaluating pilot studies with smaller biotech companies in fighting COVID-19. We constantly evaluating new trials to address an important question unanswered in the fight against COVID-19.

Completed COVID-19 Clinical Trials at Saint John’s Health Center

With the onset of the pandemic in our community early in 2020, we enrolled over 200 patients to therapeutic trials. Not only did this give our patients access to life-saving medications, but we were also able to contribute on a large scale to advance the science and research around COVID-19. Many of these therapies, like Remdesivir and monoclonal antibodies to spike protein, have become routine in the treatment of COVID-19 infections.

  1. Sarilumab – In collaboration with Regeneron Pharmaceuticals, SJCI conducted a phase 2 & 3 clinical trial to evaluate Sarilumab in adult patients hospitalized with COVID-19. This trial uses an IL-6 inhibitor agent to combat the disease.
  2. Remdesivir – In collaboration with Gilead Sciences, SJCI conducted two phase 3 clinical trials to evaluate Remdesivir in participants with moderate and severe coronavirus disease compared to standard of care treatment. These trials use an antiviral agent to combat the disease.
  3. Remdesivir +/- Tocilizumab – Hoffmann-La Roche sponsored a phase III, randomized, double-blind study of Remdesivir plus Tocilizumab (another IL-6 inhibitor) compared with Remdesivir plus placebo in hospitalized patients with severe COVID-19 pneumonia
  4. Convalescent Plasma – in conjunction with The Red Cross, this trial used the same technique used in the Ebola crisis, this time-tested technique uses antibodies from patients that recovered from the disease and injects them into patients that are sick.
  5. Novartis IL1b – IL18 – Bispecific anti-inflammatory first in human study, phase 1 and phase 2. With our very extensive work in immunotherapy basic science and treatment for cancer, we are experts in use of immunotherapeutic drugs. We are working closely with pharmaceutical companies and researchers using the above immune drugs for anti-inflammatory purposes for the lung.
  6. Monoclonal antibodies to spike protein – This step in passive antibody treatment, antibodies will be directed toward the spike protein on the COVID-19 virus. Saint John‘s Health Center was a front runner in this trial across the nation.
  • Inpatient Trial – While the current Emergency Use Authorization (EUA) is for only high-risk outpatients, this trial is an important therapy to use for hospitalized patients with COVID-19 related symptoms
  • Outpatient High Risk, Symptomatic
  • Outpatient Asymptomatic or Low Risk Symptomatic

To participate in a COVID-19 clinical trial contact us at:

COVID19Trials@jwci.org, call 310-582-7437, or fill out our online request form.