Providence at forefront of COVID-19 clinical research
The outbreak of coronavirus disease 2019 (COVID-19) brought about an unprecedented global threat to public health. Providence has been at the forefront of COVID-19 treatment and research in the United States since the nation’s first confirmed case was treated successfully at Providence Regional Medical Center Everett in Washington. Shortly afterward, sites across our family of organizations opened COVID-19 treatment and research trials to offer patients access to investigational therapies.
At Providence Cancer Institute, our Mission to care for the poor and vulnerable compels us to join the worldwide fight against COVID-19. With expertise in immunotherapy and clinical research, our investigators were among the first in the nation, and the first in Oregon, to offer antibody testing for health care workers. Our immunologists swiftly applied expertise in cancer vaccines to testing a vaccine for COVID-19 and studying the presence of antibodies to COVID-19 in breast milk following vaccination. In collaboration with Providence Infectious Disease and Internal Medicine doctors, our Clinical Research office quickly launched studies of remdesivir and other investigational therapies for patients with COVID-19.
Pilot study to evaluate antibodies to COVID-19 in breast milk
Providence Cancer Institute recently announced results of a pilot study of antibodies to COVID-19 found in the breast milk of lactating mothers after COVID-19 vaccination. The study evaluated breast milk samples from six lactating women who received both doses of the Pfizer-BioNTech or Moderna vaccine between December 2020 and January 2021.
Breast milk samples were collected before and after COVID-19 vaccination. Researchers observed antibodies to SARS-CoV-2, the virus that causes COVID-19, in the breast milk samples provided after vaccination.
The research suggests babies may be protected from COVID-19 by receiving antibodies through breast milk following their mothers' vaccinations. However, it is not known how long the antibodies will remain in the mothers or the infants.
There is more to learn, and these results are worthy of continued evaluation. Providence researchers are seeking additional funding to expand the study to a larger group of participants. For more information, read our To Your Health blog.
COVID-19 vaccine trial supported by National Institutes of Health
Providence Cancer Institute is fast-tracking development of a first-in-human vaccine trial against SARS-CoV-2, the virus that causes COVID-19, administered with immune-boosting interleukin 12 plasmid. The U.S. Food and Drug Administration approved the vaccine for clinical trial testing in late October.
The Providence vaccine is unique in that it incorporates immunotherapy expertise scientists have developed throughout three decades of cancer research at the Earle A. Chiles Research Institute.
The trial is designed with older adults in mind. Providence researchers anticipate older adults - who are among the most vulnterable to life-threatening illness from COVID-19 - may not receive adequate protection from other COVID-19 vaccines in development. The Providence vaccine trial aims to boost the immune response in older adults by mobilizing the immune system on two fronts simultaneously – antibodies and T cells – both targeting the virus’ spike protein which attaches to and infects a person’s healthy cells.
The study is a collaboration between Providence, biotech companies OncoSec and UbiVac, and the National Institutes of Health.
PI: Rom Leidner, M.D.
Co-PI: Bernard Fox, Ph.D.
For more information, see our press release.
Phase III studies of remdesivir with Gilead Sciences
Providence St. Vincent Medical Center and Providence Portland Medical Center were the first sites in Oregon to offer interventional trials of remdesivir, the antiviral agent first tested for COVID-19 at Providence in Everett:
Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™):
- in Participants with Severe COVID-19 (NCT04292899)
- in Participants with Moderate COVID-19 Compared to Standard of Care Treatment (NCT04292730)
PI: Tobias Pusch, M.D.
Enrollment is closed for both studies. A total of 33 patients participated and analysis is ongoing.
While remdesivir has not received FDA approval, early results show a therapeutic benefit for patients with severe COVID-19. The Oregon Health Authority is approved to distribute remdesivir to hospitals statewide under a federally issued Emergency Use Authorization.
Phase II/III study of sarilumab with Regeneron
Providence Portland Medical Center and Providence St. Vincent Medical Center are the first sites in Oregon to offer patients with COVID-19 access to sarilumab, a monoclonal antibody approved for the treatment of rheumatoid arthritis:
Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients with COVID-19 (NCT04315298)
PI: Jason Wells, M.D.
Compassionate use study of convalescent plasma with Mayo Clinic
Plasma from recovered COVID-19 patients contains antibodies that may help fight the disease. Providence St. Vincent Medical Center and Providence Portland Medical Center are among nearly 2,400 sites nationwide participating in Mayo Clinic’s study of convalescent plasma:
Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19 (NCT04338360)
PI: Stacy Lewis, M.D.
COVID-19 antibody study for Providence caregivers
Researchers at Earle A. Chiles Research Institute, a division of Providence Cancer Institute, launched the first study in Oregon to test health care workers for antibodies to COVID-19. The study, titled “SARS-CoV-2 Serosurveillance Protocol for PSJH Health Care Workers,” is available to caregivers across Providence.
PI: Rom Leidner, M.D.
The study is closed to enrollment. More than 10,000 Providence caregivers in Oregon participated. To learn more about this study, read our Providence Pulse newsletter.
Referral and contact information
New COVID-19 research studies are coming soon. Please visit our website to view our COVID-19 studies, and all cancer studies currently open at Providence Cancer Institute.
For more information about these studies, or to enroll a patient, contact our Clinical Research office.
More COVID-19 news and resources from Providence
We are committed to supporting our communities with information you can trust. Find hope and comfort with resources, news, and guidance as we weather this extraordinary time together:
We are here to support you and safely continue in-person visits in our clinics, as well as telephone visits and virtual visits from your home.
In a New England Journal of Medicine article, Providence doctors share study results of patients with severe cases of COVID-19 who received remdesivir for 5 and 10 days.
Article featuring multiple Providence doctors published in the Journal for ImmunoTherapy of Cancer focuses on immunological manipulations to lessen the severity of COVID-19.
Rod Hochman, M.D., Providence president and CEO, hosted a LinkedIn Live three-part series on the science of COVID-19, with Walter J. Urba, M.D., Ph.D., physician executive for research, and other Providence leaders.
At Providence, our history of providing compassionate care through difficult times dates back to our roots with the Sisters of Providence and Sisters of St. Joseph. Hear from Sister Mary Therese Sweeney about the importance of compassion during the coronavirus pandemic in a recent Facebook Live event hosted by Providence leaders.
For additional news and resources from Providence St. Joseph Health, visit our Coronavirus Resource Hub.