Immediately after COVID-19 was declared a global pandemic, CHR launched a randomized clinical trial that tested the antiviral drug remdesivir (brand name Veklury) as a treatment for Kaiser Permanente Northwest members hospitalized with COVID.
Distinguished Investigator Richard Mularski, MD, lead the study comparing treatment for five days with treatment for 10 days. Distinguished Investigator Stephen Fortmann, MD, a study Co-Investigator, reported that equivalent results between the groups led health care providers to select a five-day regimen of remdesivir for members hospitalized with COVID in most cases.
A different remdesivir study conducted by the National Institutes of Health (NIH), which CHR was not a part of, found that patients with severe COVID who received remdesivir recovered more quickly than patients who received a placebo.
Two more studies funded by NIH and led by Dr. Mularski were completed at KPNW’s Sunnyside and Westside hospitals. These studies tested the addition of other treatments to remdesivir.
The first of these studies centered on baricitinib (brand name Olumiant), a drug used to treat rheumatoid arthritis. More than 1,000 people were enrolled in the study, which compared remdesivir plus a placebo with remdesivir plus baricitinib.
The results, published in December 2020 in the New England Journal of Medicine, showed that combining remdesivir and baricitinib was a more effective way to treat COVID-19 than remdesivir alone. More patients recovered in the group receiving the combination, and patients in this group had a shorter time to recovery. Hospitalized patients needing oxygen appeared to benefit the most.
Kaiser Permanente Northwest and CHR were the only KP sites nationally participating in this trial.
The second study compared remdesivir plus a placebo with remdesivir plus interferon-beta 1a (brand name Rebif), a drug used to treat multiple sclerosis. The study did not find a benefit of adding interferon to remdesivir in treating patients hospitalized with COVID-19.
COVID-19 Vaccine vs Placebo
This was the first trial of the innovative mRNA-based vaccine against COVID-19 (BNT162b2) developed by Pfizer and BioNTech, which has since been given to millions of people. It began in July 2020 — 6 months after the COVID-19 virus (SARS-CoV-2) was identified, which was an unprecedented speed. The study enrolled more than 44,000 individuals worldwide, including 98 KPNW members. Half of the members received the active vaccine (the first individuals in Portland to receive it) and half the placebo, and no one, including the CHR investigators (led by Dr. Fortmann), was aware of who received the vaccine and who the placebo.
Thanks in part to the large number of participants, the trial provided clear evidence that the vaccine was safe and effective. It prevented over 90% of infections; as well, virtually none of those vaccinated became sick enough to need hospitalization, and none died. The vaccine was approved by the FDA and CDC for use in the public less than 6 months after the trial started. After it was found to be effective, KPNW was authorized to “break the blind” and give the placebo group the active vaccine in December 2020.
COVID-19 Vaccine Booster vs Placebo
This study tested whether a booster dose (of BNT162b2) was effective in preventing COVID-19 among healthy individuals who had received two doses of the vaccine at least 6 months previously. The study helped establish the effectiveness of such a strategy. Dr. Fortmann led the study at CHR.
The RECOVER-HEROES network was a CDC-funded, multi-state prospective cohort study involving health care personnel, first responders and other essential and frontline workers in Portland who were followed from Spring 2020 to early 2023. The objective was to examine the effectiveness of COVID vaccines in preventing infection and/or reducing the severity of SARS-CoV-2 infection. The vaccines were found to be highly effective in preventing infection.
The Viral Testing and Local Surveillance study (VITALS) was a CDC-funded project to explore potential gaps in clinician-ordered testing for SARS-CoV-2. One aim was to describe the incidence, clinical testing patterns and characteristics of less severe COVID-19 in KPNW’s ambulatory and virtual care settings. Using comprehensive electronic health records, researchers were able to describe the clinical-care trajectory of members who presented for COVID-19-related care through virtual visits. The second aim was to enhance surveillance of COVID-19 by testing nasal swabs for both influenza and COVID-19 from people who were referred for COVID-19 testing but didn’t complete the test at the time.
The Epidemiology of SARS-CoV-2 in Pregnancy and Infancy (ESPI) Network: Electronic Cohort (eESPI) collected health record data of a retrospective cohort of pregnant women and their infants who were born during the COVID-19 pandemic. This CDC-funded network used data from a large, diverse cohort of pregnant people receiving antenatal and peripartum care at KPNW and two other integrated health care networks in the United States during the first year of the COVID-19 pandemic.
COVID-19 Vaccination and Mortality
To assess mortality not associated with COVID-19 after vaccination against the disease in a general population setting, members from seven VSD sites, including the Center for Health Research, conducted a cohort study among approximately 11 million people enrolled in VSD sites. After standardizing mortality rates by age and sex, the study found that COVID-19 vaccine recipients had lower non-COVID-19 mortality than did unvaccinated individuals.