A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Severe COVID-19
The purpose of this study is to provide remdesivir (RDV) to participants with severe COVID-19. The primary objective of this study is to evaluate the efficacy of 2 RDV regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14. The secondary objective of this study is to evaluate the safety and tolerability of RDV.
Clinical evaluation of saliva and anterior nares swabs for COVID-19 testing
The objective of this study is to determine if patient-collected saliva or nares swabs are as sensitive as provider-collected nasopharyngeal/oropharyngeal swabs using the Roche SARS-CoV-2 RT-PCR test, in order to inform strategies for expanding COVID-19 testing.
Comparing Strategies for Implementing Primary HPV Testing for Routine Cervical Cancer Screening
The major goal of this project is to compare two implementation strategies to facilitate adoption of primary HPV testing for routine cervical cancer screening measured by patient-, provider- and system-centered outcomes. A sub-analysis and survey data collection will evaluate the impact of the COVID pandemic on this practice change and cervical cancer screening.
COVID-19 Population Based evaluation
This proposed surveillance project to be conducted in the VSD will utilize electronically stored health care administrative data using a combination of ICD-10 and/or internal diagnostic codes (DxID codes) to identify patients with COVID-19 and indicators of severe illness (e.g., leading to hospitalization, ICU admission, mechanical ventilation or death). In addition, health care diagnostic and procedure codes will be used to identify high risk conditions.
Development and application of a smartphone-based data collection method for adverse events following SARS-CoV-2 vaccination in the Vaccine Safety Datalink
The proposed project will involve designing, piloting, evaluating, and expanding an SMS- and web-based Vaccine Safety Monitoring (VSM) system.
EPI-ZOSTER-031 VE, Long-term effectiveness study of Shingrix in US adults>=50 years
The objective is to conduct a long-term study at KPSC to assess vaccine effectiveness among individuals receiving recombinant zoster vaccine (RZV) compared to individuals not receiving RZV.
EPI-ZOSTER-089 Effect of RZV on reducing the risk of hospitalization due to COVID-19
The Recombinant Adjuvanted Zoster Vaccine (RZV, Shingrix®) was approved in 2017 by the FDA for the prevention of herpes zoster (HZ) in adults ages =50 years. With a potent adjuvant system, it is hypothesized that RZV could induce trained innate immunity. As the first approved and widely used vaccine with the novel AS01 adjuvant system, we are investigating the potential non-specific effect of RZV against COVID-19.
Feasibility Assessment prior to conducting a BNT162b2 Vaccine Effectiveness case-control study at Kaiser Permanente South California
The objectives of this large retrospective data-only study are to use two parallel study designs to assess the VE of Pfizer COVID-19 vaccine against 2 primary endpoints: 1.) Severe outcomes (COVID-19 associated hospitalization, ICU admission, and death); and 2.) Outpatient laboratory-confirmed COVID-19 diagnosis.
Real-World Study of Effectiveness of Moderna COVID-19 Vaccine under Emergency Use Authorization and Subsequent Licensure
An observational cohort study to evaluate vaccine effectiveness of Moderna COVID-19 vaccine in preventing COVID-19 diagnosis and severe COVID-19 disease.
Shingrix Aid- Concept Protocol
The objectives of this study are to evaluate the real-world effectiveness and safety of recombinant zoster vaccine (RZV) in patients with rheumatoid arthritis (RA) and patients with inflammatory bowel disease (IBD), including ulcerative colitis (UC) or Crohn’s disease (CD).
The Comparative effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism
The overall goal of this project is to provide information on the benefits and harms comparing different treatment options for the extended treatment of VTE, information that can be used by clinicians and patients in deciding on the optimal treatment strategy.
COVID-19-Related Project Enhancement
Recent studies have reported that COVID-19 is associated with abnormal coagulation profiles and may predispose patients to VTE and other types of thrombotic events. The goals of this study are to determine the risk of VTE following COVID-19 hospitalization and whether the risk of post-hospitalization VTE varies by age, prior history of VTE or severity of COVID-19.
The Impact of Air Pollution Exposure on COVID-19 Severity and Mortality
The major goals of this project are to investigate the association of short- and long-term exposures to ambient air pollution and traffic-related air pollution with COVID-19 severity and fatality among patients in Southern California.
Trends in Incidence of Hospitalized Acute Myocardial Infarction
The major goal of this project is to examine recent trends in incidence of hospitalized myocardial infarction among members in the Kaiser Permanente Southern California region aged 35 years and older.
COVID-19-Related Project Enhancement
National surveillance data from the U.S. Centers for Disease Control and Prevention suggest a decline in emergency department visits during the Covid-19 pandemic. The goal of this study is to understand the impact of the stay-at-home orders on health care utilization and delays in care for acute myocardial infarction during the Covid-19 pandemic.
Understanding and supporting COVID-19 vaccine confidence among health care providers
The purpose of this mixed-methods study is to examine perceptions of COVID-19 vaccines among health care providers, willingness to receive and recommend COVID-19 vaccine, drivers of vaccine hesitancy, and needs for tailored interventions to support confidence in COVID-19 vaccines among health care providers and community members.
Utilizing Real World Data to Describe Clinical and Safety Outcomes Among Hospitalized COVID-19 Patients, and to Create a Comparator Arm for a Randomized Controlled Trial Evaluating the Efficacy and Safety of Actemra for COVID-19 Patients
Elevated tissue and serum levels of IL-6 have been implicated in the disease pathology of several inflammatory and autoimmune disorders including rheumatoid arthritis, systemic juvenile idiopathic arthritis (sJIA), and cytokine-release syndrome (CRS). Tocilizumab or TCZ (Actemra) is a recombinant humanized, anti-human monoclonal antibody directed against soluble and membrane-bound IL-6R. On March 3rd 2020, TCZ was included in the updated diagnosis and treatment plan for COVID-19 issued by the China National Health Commission as one treatment option for severe or critical forms of COVID-19 pneumonia. However, despite fairly widespread use in China, Actemra has not received health authority approval for COVID-19 in any country. More robust clinical evidence regarding the safety or efficacy of TCZ in the treatment of COVID-19 is needed. Roche is conducting a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of TCZ in combination with SOC compared with matching placebo in combination with SOC in hospitalized adult patients with severe COVID-19 pneumonia (n=330). KPSC is collecting demographic, comorbidity, and clinical information on KPSC patients hospitalized with COVID-19 infection to create a real world data (RWD) comparator arm that will be matched to the TCZ treatment arm of the RCT.