The U.S. Food and Drug Administration authorized use of mRNA COVID-19 bivalent booster vaccines on August 31, 2022. Currently, CDC's clinical guidance states that COVID-19 and other vaccines may be administered simultaneously. At time of authorization and recommendations, limited data…
The challenge of accounting for practice effects (PEs) when modeling cognitive change was amplified by the COVID-19 pandemic, which introduced period and mode effects that may bias the estimation of cognitive trajectory. In three Kaiser Permanente Northern California prospective cohorts,…
Catastrophic disruptions in care delivery threaten the operational efficiency and potentially the validity of clinical research efforts, in particular randomized clinical trials. Most recently, the COVID-19 pandemic affected essentially all aspects of care delivery and clinical research conduct. While consensus…
There are limited data on influenza vaccination coverage among pregnant people in the United States during the coronavirus disease 2019 (COVID-19) pandemic. Within the Vaccine Safety Datalink, we conducted a retrospective cohort study to examine influenza vaccination coverage during the…
The epidemiology of COVID-19 continues to develop with emerging variants, expanding population-level immunity, and advances in clinical care. We describe changes in the clinical epidemiology of hospitalized COVID-19 and risk factors for critical outcomes over time. We included adults aged…
Immunocompromised (IC) persons are at increased risk for severe COVID-19 outcomes and are less protected by 1-2 COVID-19 vaccine doses than are immunocompetent (non-IC) persons. We compared vaccine effectiveness (VE) against medically attended COVID-19 of 2-3 mRNA and 1-2 viral-vector…
On June 19, 2022, the original monovalent mRNA COVID-19 vaccines were approved as a primary series for children aged 6 months-4 years (Pfizer-BioNTech) and 6 months-5 years (Moderna) based on safety, immunobridging, and limited efficacy data from clinical trials. On…
Traditional active vaccine safety monitoring involves pre-specifying health outcomes and biologically plausible outcome-specific time windows of concern, limiting the adverse events that can be evaluated. In this study, we used tree-based scan statistics to look broadly for >60,000 possible adverse…
Randomized controlled trials (RCTs) remain the gold standard for evaluating treatment efficacy, but real-world evidence can supplement RCT results. Tocilizumab was not found to reduce 28-day mortality in a phase III, double-blind, placebo-controlled trial (COVACTA) among hospitalized patients with severe…
The COVID pandemic prompted a significant increase in the utilization of telemedicine (TM) for substance use disorder (SUD) treatment. As we transition towards a "new normal" policy, it is crucial to comprehensively understand the evidence of TM in SUD treatment…
COVID-19 has been associated with endothelial injury, resultant microvascular inflammation and thrombosis. Activated endothelial cells release and express P-selectin and von Willebrand factor, both of which are elevated in severe COVID-19 and may be implicated in the disease pathophysiology. We…
Few population-based studies in the US collected individual-level data from families during the COVID-19 pandemic. To examine differences in COVID-19 pandemic-related experiences in a large sociodemographically diverse sample of children and caregivers. The Environmental influences on Child Health Outcomes (ECHO)…
Safety data on simultaneous vaccination (SV) with primary series monovalent COVID-19 vaccines and other vaccines are limited. We describe SV with primary series COVID-19 vaccines and assess 23 pre-specified health outcomes following SV among persons aged ≥5 years in the Vaccine Safety…
The COVID-19 pandemic accelerated the use of telemedicine. However, data on the integration of telemedicine in prenatal health care and health outcomes are sparse. To evaluate a multimodal model of in-office and telemedicine prenatal health care implemented during the COVID-19…
Our recently published study of >2.4 million adults in Northern California indicated that current versus never-tobacco smoking was associated with lower risk of SARS-CoV-2 infection and less severe coronavirus disease 2019 (COVID-19). We extended this research by evaluating whether these…
In this multisite, observational, matched cohort study of more than 80,000 pregnant people, receipt of an mRNA monovalent coronavirus disease 2019 (COVID-19) booster vaccination in pregnancy was not associated with increased risk for thrombocytopenia, myocarditis, venous thromboembolism, ischemic stroke, or…
Understanding the usefulness of additional COVID-19 vaccine doses-particularly given varying disease incidence-is needed to support public health policy. We characterize the benefits of COVID-19 booster doses using number needed to vaccinate (NNV) to prevent one COVID-19-associated hospitalization or emergency department…
COVID-19 (coronavirus disease 2019) is associated with heightened risks of venous and arterial thrombosis and hospitalization due to respiratory failure. To assess whether prophylactic anticoagulation can safely reduce the frequency of venous and arterial thrombosis, hospitalization, and death in nonhospitalized…
Introduction Information about demographic differences in social risks, needs, and attitudes toward social health screening in non-highly vulnerable adult populations is lacking. Methods The authors analyzed data for 2869 Kaiser Permanente Northern California non-Medicaid-covered members aged 35 to 85 who…
On September 1, 2022, CDC's Advisory Committee on Immunization Practices (ACIP) recommended a single bivalent mRNA COVID-19 booster dose for persons aged ≥12 years who had completed at least a monovalent primary series. Early vaccine effectiveness (VE) estimates among adults…
The association between SARS-CoV-2 genomic variation and breakthrough infection is not well-defined among persons with Delta variant SARS-CoV-2 infection. In a retrospective cohort we assessed whether individual non-lineage defining mutations and overall genomic variation (including low frequency alleles) were associated…
Mental health and substance use disorders disproportionately affect people with HIV (PWH), and may have been exacerbated during COVID-19. The Promoting Access to Care Engagement (PACE) trial was designed to assess the effectiveness of electronic screening for mental health and…
Addiction treatment rapidly transitioned to a primarily telehealth modality (telephone and video) during the COVID-19 pandemic, raising concerns about disparities in utilization. To examine whether there were differences in overall and telehealth addiction treatment utilization after telehealth policy changes during…
We assessed BNT162b2 vaccine effectiveness (VE) against mild to moderate and severe coronavirus disease 2019 (COVID-19) in children and adolescents through the Omicron BA.4/BA.5 period. Using VISION Network records from April 2021 to September 2022, we conducted a test-negative, case-control…
Adherence to COVID-19 booster vaccine recommendations has lagged in pregnant and nonpregnant adult populations. One barrier to booster vaccination is uncertainty regarding the safety of booster doses among pregnant people. To evaluate whether there is an association between COVID-19 booster…
We assessed coronavirus disease 2019 (COVID-19) vaccination impact on illness severity among adults hospitalized with COVID-19, August 2021-March 2022. We evaluated differences in intensive care unit (ICU) admission, in-hospital death, and length of stay among vaccinated (2 or 3 mRNA…
Limited data exist on pediatric health care utilization during the COVID-19 pandemic among children and young adults born preterm. To investigate differences in health care use related to COVID-19 concerns during the pandemic among children and young adults born preterm…
During June-October 2022, the SARS-CoV-2 Omicron BA.5 sublineage accounted for most of the sequenced viral genomes in the United States, with further Omicron sublineage diversification through November 2022.* Bivalent mRNA vaccines contain an ancestral SARS-CoV-2 strain component plus an updated…
In the Vaccine Safety Datalink (VSD), we previously reported no association between COVID-19 vaccination in early pregnancy and spontaneous abortion (SAB). The current study aims to understand how time since vaccine roll-out or other methodologic factors could affect results. Using…
Recent SARS-CoV-2 Omicron variant sublineages, including BA.4 and BA.5, may be associated with greater immune evasion and less protection against COVID-19 after vaccination. To evaluate the estimated vaccine effectiveness (VE) of 2, 3, or 4 doses of COVID-19 mRNA vaccination…
We examined the effectiveness of maternal vaccination against SARS-CoV-2 infection in 30,311 infants born at Kaiser Permanente Northern California from December 15, 2020, to May 31, 2022. Using Cox regression, the effectiveness of ≥2 doses of COVID-19 vaccine received during…
The safety of COVID-19 vaccines plays an important role in addressing vaccine hesitancy. We conducted a large cohort study to evaluate the risk of non-COVID-19 mortality after COVID-19 vaccination while adjusting for confounders including individual-level demographics, clinical risk factors, health…
In October 2021, Emergency Use Authorization of Coronavirus Disease 2019 (COVID-19) vaccines was granted for children aged 5-11. To ensure vaccine uptake in children upon approval, California will implement a state-wide executive order mandating COVID-19 vaccination for school children following…
The financial hardships and social isolation experienced during the COVID-19 pandemic have been found to adversely affect children's developmental outcomes. While many studies thus far have focused on school-aged children and the pandemic-related impacts on their academic skills and behavior…
Quantitative studies indicate that the COVID-19 pandemic has contributed to increased rates of prenatal cannabis use. However, little is known about how the pandemic has impacted cannabis use from the perspective of pregnant individuals themselves. Our objective was to characterize…
Ongoing pediatric cohort studies offer opportunities to investigate the impact of the COVID-19 pandemic on children's health. With well-characterized data from tens of thousands of US children, the Environmental influences on Child Health Outcomes (ECHO) Program offers such an opportunity…
During June-October 2022, the SARS-CoV-2 Omicron BA.5 sublineage accounted for most of the sequenced viral genomes in the United States, with further Omicron sublineage diversification through November 2022.* Bivalent mRNA vaccines contain an ancestral SARS-CoV-2 strain component plus an updated…
We are providing technical expertise, consultation, and enrolling participants in a randomized clinical trial to evaluate the safety of simultaneous mRNA COVID-19 vaccine with other childhood vaccines in young children aged 6 months to 5 years.
Persons with moderate-to-severe immunocompromising conditions might have reduced protection after COVID-19 vaccination, compared with persons without immunocompromising conditions (1-3). On August 13, 2021, the Advisory Committee on Immunization Practices (ACIP) recommended that adults with immunocompromising conditions receive an expanded primary…
We examined the effectiveness of maternal vaccination against SARS-CoV-2 infection in 30,288 infants born at Kaiser Permanente Northern California from December 15, 2020, to May 31, 2022. Using Cox regression, the effectiveness of maternal vaccination was 85% (95% confidence interval…
To estimate the effectiveness of mRNA vaccines against moderate and severe covid-19 in adults by time since second, third, or fourth doses, and by age and immunocompromised status. Test negative case-control study. Hospitals, emergency departments, and urgent care clinics in…
Using quasi-experimental research methods, this study is assessing the extent to which disparities in type 2 diabetes prevention and outcomes were exacerbated during the coronavirus disease 2019 (COVID-19) pandemic between the Medi-Cal and commercially-insured populations. The career development plan for…
Pregnant people are at high risk for severe COVID-19 but were excluded from mRNA vaccine trials; data on COVID-19 vaccine effectiveness (VE) are needed. To evaluate the estimated effectiveness of mRNA vaccination against medically attended COVID-19 among pregnant people during…
Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. We assessed if risk differs using comprehensive health records on…
Coronavirus disease 2019 (COVID-19) breakthrough infections are common. Evaluate in-hospital mortality of patients with COVID-19 by vaccination status using retrospective cohort study. We generated propensity scores for receipt of full vaccination in adults requiring supplemental oxygen hospitalized at Kaiser Permanente…
The Omicron variant (B.1.1.529) of SARS-CoV-2, the virus that causes COVID-19, was first identified in the United States in November 2021, with the BA.1 sublineage (including BA.1.1) causing the largest surge in COVID-19 cases to date. Omicron sublineages BA.2 and…
Increased stress has likely contributed to the observed high prevalence of depression and anxiety in pregnant individuals during the COVID-19 pandemic. The objective of this study was to assess the prevalence of coping strategies for COVID-19 pandemic-related stress and associations…
COVID-19 morbidity is highest in Black and Latino older adults. These racial and ethnic groups initially had lower vaccination uptake than others, and rates in Black adults continue to lag. To evaluate the effect of outreach via electronic secure messages…
The COVID-19 pandemic caused an abrupt drop in in-person health care (inpatient, Emergency Department, outpatient) and an increase in telehealth care, which poses challenges in vaccine safety studies that identify outcomes from in-person encounters. We examined the changes in incidence…
Active immunization with the BNT162b2 vaccine (Pfizer-BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the coronavirus disease 2019 (Covid-19) pandemic. In light of reports of waning protection occurring 6 months after…
The overall goals are to: Determine COVID-19 vaccine effectiveness in pregnant women for preventing laboratory-confirmed COVID-19 and hospitalization for COVID-19 using real-world clinical data; Determine effectiveness of maternal COVID-19 vaccination during pregnancy for infants 0-12 months for outcomes of laboratory-confirmed…
Postauthorization monitoring of vaccines in a large population may detect rare adverse events not identified in clinical trials such as Guillain-Barré syndrome (GBS), which has a background rate of 1 to 2 per 100 000 person-years. To describe cases and incidence…
CDC recommends that all persons aged ≥18 years receive a single COVID-19 vaccine booster dose ≥2 months after receipt of an Ad.26.COV2.S (Janssen [Johnson & Johnson]) adenovirus vector-based primary series vaccine; a heterologous COVID-19 mRNA vaccine is preferred over a…
The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 5-11, 12-15, and 16-17 years (1-3). Limited real-world data on 2-dose mRNA vaccine effectiveness (VE) in persons aged 12-17…
Between May 2005 and March 2007, three vaccines were recommended by the Advisory Committee on Immunization Practices for routine use in adolescents in the United States: quadrivalent meningococcal conjugate vaccine (MenACWY), tetanus, diphtheria and acellular pertussis vaccine (Tdap), and human…
CDC recommends that all persons aged ≥12 years receive a booster dose of COVID-19 mRNA vaccine ≥5 months after completion of a primary mRNA vaccination series and that immunocompromised persons receive a third primary dose.* Waning of vaccine protection after…
We are studying the genomes of SARS-CoV-2 in persons with COVID-19 with and without vaccination to identify and describe variants circulating within our patients, including variants of concern (such as Delta or Omicron. We also are assessing which shared genomic…
Estimates of COVID-19 mRNA vaccine effectiveness (VE) have declined in recent months (1,2) because of waning vaccine induced immunity over time,* possible increased immune evasion by SARS-CoV-2 variants (3), or a combination of these and other factors. CDC recommends that…
Objective: This study evaluated whether COVID-19 pandemic-related health, healthcare and economic factors during pregnancy are associated with prenatal depression and anxiety. Methods: We conducted a cross-sectional study of 6,628 pregnant members of Kaiser Permanente Northern California who responded to a…
This study aimed to identify racial and ethnic disparities in prenatal mental health and identify COVID-19 pandemic-related health/healthcare and economic contributors to these disparities, using an established framework for disparity investigation. This cross-sectional study includes 10,930 pregnant people at Kaiser…
The COVID-19 pandemic has affected routine vaccine delivery in the US and globally. The magnitude of these disruptions and their association with childhood vaccination coverage are unclear. To compare trends in pediatric vaccination before and during the pandemic and to…
Among approximately 4.6 million members of Kaiser Permanente Northern California, we examined associations of severe COVID-19 with demographic factors and comorbidities. As of July 23, 2021, 16 182 had been hospitalized, 2416 admitted to an ICU, and 1525 died due to…
We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe coronavirus disease 2019 (COVID-19) using data from a phase 3 remdesivir trial and a retrospective cohort of patients with severe COVID-19 treated with standard…
An estimated 10 million people in the USA are immunocompromised, a risk factor for severe COVID-19. Data informing whether immune-mediated medications lead to more severe infection are sparse. Determine whether outpatient immunosuppressive therapies that treat autoimmune inflammatory disease or prevent…
Population-level reports of suicide-related emergency department (ED) encounters among youth during the COVID-19 pandemic are lacking, along with youth characteristics and preexisting psychiatric service use. To characterize population-level and relative change in suicide-related ED encounters among youth during the COVID-19…
Previous infection with SARS-CoV-2 (the virus that causes COVID-19) or COVID-19 vaccination can provide immunity and protection from subsequent SARS-CoV-2 infection and illness. CDC used data from the VISION Network* to examine hospitalizations in adults with COVID-19-like illness and compared…
Immunocompromised persons, defined as those with suppressed humoral or cellular immunity resulting from health conditions or medications, account for approximately 3% of the U.S. adult population (1). Immunocompromised adults are at increased risk for severe COVID-19 outcomes (2) and might…
In partnership with the California Emerging Infection Program and the California Department of Public Health, Kaiser Permanente Northern California will contribute to statewide whole genome sequencing efforts for surveillance for SARS-CoV-2 variants of concern by submitting samples from all vaccine…
Telehealth use including secure messages has rapidly expanded since the COVID-19 pandemic, including for multidisciplinary aspects of cancer care. Recent reports described rapid uptake and various benefits for patients and clinicians, suggesting that telehealth may be in standard use after…
The COVID-19 pandemic has heightened concerns about the impact of depression, anxiety, alcohol, and drug use on public health. Mobile apps to address these problems were increasingly popular even before the pandemic, and may help reach people who otherwise have…
By September 21, 2021, an estimated 182 million persons in the United States were fully vaccinated against COVID-19.* Clinical trials indicate that Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), and Janssen (Johnson & Johnson; Ad.26.COV2.S) vaccines are effective and generally well tolerated (1-3)…
This study examined changes in psychotropic medication use associated with the early months of the coronavirus disease 2019 (COVID-19) pandemic. Using Kaiser Permanente Northern California electronic health records, the authors identified adult patients with fills for psychotropic medications and a…
Safety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy. To monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population. This study represents an interim analysis of safety surveillance data…
There are limited data on the effectiveness of the vaccines against symptomatic coronavirus disease 2019 (Covid-19) currently authorized in the United States with respect to hospitalization, admission to an intensive care unit (ICU), or ambulatory care in an emergency department…
COVID-19 has proved enormously disruptive to the provision of cancer screening, which does not just represent an initial test but an entire process, including risk detection, diagnostic follow-up, and treatment. Successful delivery of services at all points in the process…
Limited existing data suggest that the novel COVID-19 may increase risk of VTE, but information from large, ethnically diverse populations with appropriate control participants is lacking. Does the rate of VTE among adults hospitalized with COVID-19 differ from matched hospitalized…
Data on COVID-19 vaccine effectiveness (VE) since the B.1.617.2 (Delta) variant of SARS-CoV-2, the virus that causes COVID-19, became the predominant circulating strain in the United States are limited (1-3). CDC used the VISION Network* to examine medical encounters (32,867)…
The coronavirus disease 2019 (COVID-19) pandemic remains a source of considerable morbidity and mortality throughout the world. Therapeutic options to reduce symptoms, inflammatory response, or disease progression are limited. This randomized open-label trial enrolled 100 ambulatory patients with symptomatic COVID-19…
To separately compare the long-term risk of mortality among bariatric surgical patients undergoing either RYGB or SG to large, matched, population-based cohorts of patients with severe obesity who did not undergo surgery. Bariatric surgery has been associated with reduced long-term…
In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the…
Beginning in March 2020, case reports and case series linked the COVID-19 pandemic with an increased occurrence of chilblains, but this association has not been evaluated in an epidemiologic study. To assess whether a correlation exists between COVID-19 incidence and…
This study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to study participants who previously received 2 doses of BNT162b2 at least 6 months prior to randomization.
This phase I open-label dose-finding study will evaluate the safety, tolerability, and immunogenicity of a Sars-Cov-2 RNA vaccine candidate against COVID-19 in healthy 12-year-old children.
This study will characterize and compare antecedents to hospitalization and in-hospital deterioration among patients with COVID-19 and comparator patients with influenza. We will quantify pre-existing comorbidities, medication adherence, and temporal factors prior to hospitalization with COVID-19 or influenza. We will…
To examine the value of health systems data as indicators of emerging COVID-19 activity. Observational study of health system indicators for the COVID Hotspotting Score (CHOTS) with prospective validation. An integrated healthcare delivery system in Northern California including 21 hospitals…
COVID-19 vaccination is critical to ending the COVID-19 pandemic. Members of minority racial and ethnic groups have experienced disproportionate COVID-19-associated morbidity and mortality (1); however, COVID-19 vaccination coverage is lower in these groups (2). CDC used data from CDC's Vaccine…
Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population, facilitate in-person learning and…
COVID-19 vaccines are critical for ending the COVID-19 pandemic; however, current data about vaccination coverage and safety in pregnant women are limited. Pregnant women are at increased risk for severe illness and death from COVID-19 compared with nonpregnant women of…
Racial disparities exist in outcomes after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. To evaluate the contribution of race/ethnicity in SARS-CoV-2 testing, infection, and outcomes. Retrospective cohort study (1 February 2020 to 31 May 2020). Integrated health care delivery…
This is a Brighton Collaboration Case Definition of the term "Multisystem Inflammatory Syndrome in Children and Adults (MIS-C/A)" to be utilized in the evaluation of adverse events following immunization. The case definition was developed by topic experts convened by the…
This study examines the increase in alcohol consumption during the Covid-19 pandemic and the major shift to virtual treatment modalities for alcohol problems, with a focus on potential disparities in treatment access, by race, ethnicity, age and gender. Understanding potential…
Examine the safety and effectiveness of current treatments for hospitalized patients with COVID-19 and identify patient characteristics and time periods during the disease course that are associated with more favorable treatment response.
This study will describe factors associated with the effective adoption of video visits in adult and family medicine after the start of the Covid-19 pandemic; identify medical centers and primary care physicians with higher-than-expected video visit rates after adjusting for…
Multisite study to describe the incidence, clinical presentation, treatment, clinical course, and outcomes of COVID-19 among pregnant women and up to six months postpartum, and estimate the incidence of COVID-19 hospitalizations and medically attended ambulatory care visits (including telehealth) during…
To demonstrate that the immune responses induced by BNT162b2 are consistent across the 3 U.S. lots (Lots 1, 2, and 3) in participants without evidence of SARS-CoV-2 infection during the study.
This work will support and contribute to the COVID-19 vaccine safety work of the VSD: managing site contributions, and participating on working groups and attending conference calls; providing high-quality electronic data for COVID-19 vaccine safety activities; participation on vaccine safety…
The goal of this study is to obtain COVID-19 surveillance study (questionnaire and serology) in 6 cohort studies funded by NHLBI including the CARDIA study. A surveillance questionnaire will be administered 3 times at approximately 6 month intervals and blood…
The MITIGATE study aims to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), compared with usual care, on laboratory-confirmed viral upper respiratory infection (URI)-related morbidity and mortality in adults with established atherosclerotic cardiovascular disease (ASCVD). IPE is…
Traditional mindfulness-based interventions have been shown to reduce depression symptoms in pregnant women, although in-person classes may pose significant accessibility barriers, particularly during the COVID-19 pandemic. Mobile technology offers greater convenience, but little is known regarding the efficacy of self-paced,…
The early COVID-19 pandemic resulted in great psychosocial disruption and stress, raising speculation that psychiatric disorders may worsen. This study aimed to identify patients vulnerable to worsening mental health during the COVID-19 pandemic. This retrospective observational study used electronic health…
The SARS-CoV-2 (COVID-19) pandemic continues to affect many lives globally. Patients with cancer undergoing potentially immunosuppressive therapies appear to be at particular risk for the disease and its complications. Here, we describe the experience of patients with cancer within Kaiser…
The aim of the RAAS-COVID-19 randomized control trial is to evaluate whether an upfront strategy of temporary discontinuation of renin angiotensin aldosterone system (RAAS) inhibition versus continuation of RAAS inhibition among patients admitted with established COVID-19 infection has an impact…
We will develop a protocol, coordinate, and lead Rapid Cycle Analysis (RCA) activities in order to monitor the safety of COVID-19 vaccines in near real-time and investigate possible associations between the COVID-19 vaccines and a pre-specified list of adverse events…
This study will examine the impacts that COVID-19 pandemic related changes in health care delivery had on health outcomes among pregnant women and their newborns in Kaiser Permanente Northern California. The study will also evaluate the clinical course of COVID-19…
This project aims to improve The Permanente Medical Group's capability for outpatient and population management of adults with COVID-19. It will identify the spatial, temporal, and racial distribution of coronavirus infections; characterize the clinical progression of coronavirus infection; and synthesize…
This study will assess the sero-prevalence and sero-incidence of SARS-CoV-2 infection in Kaiser Permanente Northern California and assess correlates of exposure and immunity among KPNC members.
This clinical trial will evaluate treatment with IV administered remdesivir in an outpatient setting in patients with COVID-19 who are at risk for disease progression.
This virtual, pragmatic randomized clinical trial will evaluate whether rivaroxaban reduces the risk of a composite endpoint of major venous and arterial thrombotic events, all-cause hospitalization, and all-cause mortality compared with placebo in outpatients with acute, symptomatic COVID-19 infection.
Research on COVID-19 during pregnancy has mainly focused on women hospitalized for COVID-19 or other reasons during their pregnancy. Little is known about COVID-19 in the general population of pregnant women. To describe the prevalence of COVID-19, symptoms, consequent healthcare…
: The COVID-19 pandemic is likely to exacerbate existing anxiety and substance use disorders (SUDs) and increase vulnerability among individuals previously free of these conditions. Numerous pandemic-related stressors-coronavirus infection fears, social distancing and isolation, activity restrictions, financial insecurity and unemployment,…
The decreased trend in patients seeking care for acute stroke, acute MI, and acute surgical presentations during the COVID-19 pandemic is concerning for potential long-term morbidity, mortality, rehabilitation costs, and preventable downstream health care utilization. We aim to assess the…
The goal of this project is to evaluate the impact of the COVID pandemic on colorectal cancer screening and surveillance activities, and the impact on outcomes such as colorectal cancer incidence and stage.
To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses
Shelter-in-place (SIP) orders implemented to mitigate severe acute respiratory syndrome coronavirus 2 spread may inadvertently discourage patient care-seeking behavior for critical conditions like acute ischemic stroke. We aimed to compare temporal trends in volume of acute stroke alerts, patient characteristics,…
The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure…
Assess the feasibility of conducting a cluster randomized trial (RCT) comparing technology-delivered mindfulness-based intervention (MBI) programs against a waitlist control arm targeting advanced cancer patients and their informal caregivers. Two-arm cluster RCT within Kaiser Permanente Northern California (KPNC). We recruited…
Pregnant women might be at increased risk for severe coronavirus disease 2019 (COVID-19), possibly related to changes in their immune system and respiratory physiology* (1). Further, adverse birth outcomes, such as preterm delivery and stillbirth, might be more common among…
Obesity, race/ethnicity, and other correlated characteristics have emerged as high-profile risk factors for adverse coronavirus disease 2019 (COVID-19)-associated outcomes, yet studies have not adequately disentangled their effects. To determine the adjusted effect of body mass index (BMI), associated comorbidities, time,…
As of March 26, 2020, there have been more than 80,000 cases and 1,000 deaths in the US due to COVID-19. Because it attacks the lungs, COVID-19 could be an especially serious threat to those who smoke or vape tobacco…
This pilot study will use data from Kaiser Permanente Northern California electronic health records to examine whether current and former smokers are at elevated risk for COVID-19 infection and disease severity relative to never smokers. We will also look at…
The COVID epidemic has exposed the fragility of the social network that supports our most complex and vulnerable members. We have established an interdisciplinary team of researchers, clinicians, and operational leaders at KPNC, KPCO, KPWA to study socially determined barriers…
This multi-center, multi-country retrospective cohort study will assess the clinical course and outcome of adults with severe COVID-19 not treated with remdesivir using a 7-point ordinal scale for clinical outcomes on Day 14 and all-cause mortality at Day 28 after…
Adults with intellectual or developmental disabilities may be especially impacted by the ways the COVID-19 pandemic has led to drastic changes in usual daily routines and the way healthcare encounters have been transitioned to virtual (video, telephone) visits. This project…
The MITIGATE Study will evaluate the real-world clinical effectiveness of icosapent ethyl (Vascepa®) compared to usual care in patients with established atherosclerotic cardiovascular disease. The study will evaluate whether the drug, which is used to reduce the risk of heart…
To understand the epidemiology and burden of severe coronavirus disease 2019 (covid-19) during the first epidemic wave on the west coast of the United States. Prospective cohort study. Kaiser Permanente integrated healthcare delivery systems serving populations in northern California, southern…
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