RESEARCH

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.

In this project, we will develop new statistical approaches to detect serious adverse events that can happen after vaccination, and we will apply these new approaches to existing data from a large health care system to evaluate COVID-19 vaccine safety.

The VISION Vaccine Effectiveness Network is a research collaboration between CDC, Westat, and multiple sites with integrated clinical, laboratory, and vaccination records in the United States that evaluate how well seasonal influenza (flu) vaccines protect people against flu, RSV vaccines protect people against RSV, and COVID-19 vaccines protect against COVID-19. VISION also assesses information on severe outcomes among people hospitalized with laboratory-confirmed flu and COVID-19 including intensive care unit (ICU) admission, invasive mechanical ventilation, and in-hospital death. These data help inform how well flu vaccines, RSV vaccines, and COVID-19 vaccines protect against severe outcomes.

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.

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.

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.

Collect positive SARS-CoV-2 specimens and conduct sequencing to identify variant types.

The proposed project will involve designing, piloting, evaluating, and expanding an SMS- and web-based Vaccine Safety Monitoring (VSM) system.

The objectives of this study were to assess the effectiveness of PCV13 against severe COVID-19 outcomes and to assess the burden of PCV13-preventable illness attributable to COVID-19.

This study aims to create a more effective method of modeling infectious diseases that addresses limitations learned as a result of the COVID-19 pandemic and its public health impact. Its methods adapt and create modeling and data integration methods, software, clinical data, and training to achieve this goal. This includes addressing multiple challenges such as sharing and coordinating data access, increasing access understanding of machine learning (ML), understanding the true patterns of disease transmission, having a sample to represent all infections and timelines, and reducing the gap between transmission and diagnosis. Through multiple strategies, this study will provide a more comprehensive approach to data modeling in an effort to prepare for future outbreaks.

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 and older. 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.

The current study proposes to evaluate the VE for influenza as well as the VE for COVID-19 both before and after the flu season as well as concurrently with influenza.

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.

Collect positive SARS-CoV-2 specimens and conduct sequencing to identify variant types.

This project will describe characteristics associated with prescribing and dispensing of individuals receiving Paxlovid and not receiving Paxlovid among SARS-CoV-2 positive individuals.

An observational cohort study to evaluate vaccine effectiveness of Moderna COVID-19 vaccine in preventing COVID-19 diagnosis and severe COVID-19 disease.

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 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.

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.

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.

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.

The purpose of this task order is for the contractors to contribute to the main functions of VSD COVID-19 vaccine safety activities. The work from this task order will support and contribute to the COVID-19 vaccine safety work of the VSD. The objective is to provide high quality electronic data specific to COVID-19 vaccine safety activities. Contractors will also contribute to vaccine safety assessments through their participation on vaccine safety monitoring and evaluation studies, and by conducting medical record reviews.