COVID-19

HERO-TOGETHER: A Safety Surveillance Study of Post- Vaccination Events of Interest among People Vaccinated Against COVID-19

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, Engagement, Single IRB
Principal Investigator: Emily O’Brien
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Pfizer
Funding Date: 2020
Study Duration: 2020 – 2022
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Status: Completed

Research Question(s): In this study, the research team wanted to learn if taking HCQ was safe and prevented COVID-19 in healthcare workers.

The COVID-19 and Diabetes Assessment (CODA) Study

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Russell Rothman
Site Name: Vanderbilt University Medical Center (VUMC)
PCORnet® Network Partner: STAR
Funder: NIDDK/NIH
Funding Date: 2023
Study Duration: 2023 – 2027
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Metabolic Disorders
Condition: COVID-19, Diabetes
Population: 18 Years and older (Adult, Older Adult)
Status: Not yet recruiting

Research Question(s):  The study will answer important questions patients are asking about the link between diabetes and COVID-19.

  1. To what extent does COVID-19 cause worse glycemic control, vascular function, inflammation, and increased risk for blood clots in people with either type 1 or type 2 diabetes?
  2. The study will also explore the role of genomic, social, and environmental factors on metabolic function and the impact of COVID-19 infection and COVID-19 treatments on diabetes-related outcomes.

Understanding the Short- and Long-term Effects of the COVID-19 Pandemic on the Opioid Overdose Crisis

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Magdalena Cerdá
Site Name: New York University Langone Health
PCORnet® Network Partner: INSIGHT
Funder: NIDA
Funding Date: 2023
Study Duration: 2023 – 2028
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Health Disparities
Condition: COVID-19, Opioid Use
Population: 18 Years and older (Adult, Older Adult )
Status: Active, not recruiting

Research Question(s):

  1. Did a community rise in COVID-19 hospitalizations and deaths contribute to an increase in the risk of overdose among PCORnet patients?
  2. What role did public health and economic policies enacted during the COVID-19 pandemic play in explaining whether a rise in community COVID-19 burden contributed to a rise in overdose?
  3. Did the impact of the COVID-19 pandemic on overdose depend on the socioeconomic, social, and policy characteristics the community had in place prior to the pandemic?

HERO Registry & Trial: Healthcare Worker Exposure Response and Outcomes

Posted on by Jodi Snare
Study Updated 03/28/2024
Research Question(s):

Can a research registry of people working in healthcare help to answer important questions about the COVID-19 pandemic on medications, vaccines and healthcare worker well-being?

Primary Publication(s):
Design of the Healthcare Worker Exposure Response and Outcomes (HERO) research platform
Friedland A, Hernandez AF, Anstrom KJ, et al. Design of healthcare worker exposure response and outcomes (HERO) research platform. Contemp Clin Trials, 2021; 109:106525.

Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial (HERO-HCQ)
Naggie S, Milstone A, Castro M, et al. Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial (HERO-HCQ). Medrxiv, 2021. doi: https://doi.org/10.1101/2021.08.19.21262275

 

PCORnet® Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults (PCORnetPASC)

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Website: RECOVERCOVID
ClinicalTrials.gov#: NCT05292274
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Rainu Kaushal
Site Name: Weill Cornell Medicine
PCORnet® Network Partner: INSIGHT
Funder: NIH
Funding Date: 2022
Study Duration: 2022 – 2025
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Condition: COVID-19; SARS CoV 2 Infection
Population: 18 Years and older (Adult, Older Adult)
Status: Active, not recruiting

Research Question(s):

  1. What are the long term health effects of COVID-19 after a person has recovered from infection?
  2. How can we better detect, predict, and treat these health effects and prevent future infection?

Primary Publication(s):
Prevalence of Select New Symptoms and Conditions Among Persons Aged Younger Than 20 Years and 20 Years or Older at 31 to 150 Days After Testing Positive or Negative for SARS-CoV-2
Hernandez-Romieu AC, Carton TW, Saydah S, et al. Prevalence of select new symptoms and conditions among person aged younger than 20 years and 20 years or older at 31 to 150 days after testing positive or negative for SARS-CoV-2. JAMA Netw Open. 2022;5(2):e2147053.

Comparing patient-reported impact of COVID-19 shelter-in-place policies and access to containment and mitigation strategies, overall and in vulnerable populations

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: COVID-19 Citizen Science
ClinicalTrials.gov#: NCT5548803
Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Mark Pletcher
Site Name: University of California, San Francisco
PCORnet® Network Partner: REACHnet
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2020
Study Duration: 2020 – 2023
Participating Clinical Research Networks: GPC, INSIGHT, REACHnet
Therapeutic Area: Health Disparities
Condition: COVID-19
Population: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):

  1. What is the comparative impact of different shelter-in-place/reopening policies, overall and in vulnerable populations, on patient-reported financial insecurity, mental health, and other subjective outcomes important to patients?
  2. What is the comparative effectiveness of county-level containment and mitigation strategies at achieving timely access to testing, healthcare, information, and contact tracing, overall and in vulnerable populations?
  3. What is the comparative accuracy of different algorithms designed to predict risk of infection and severe COVID-19 among patients with symptoms, overall and in vulnerable populations?

Primary Publication(s):
The COVID-19 Citizen Science Study: Protocol for a Longitudinal Digital Health Cohort Study
Beatty AL, Peyser ND, Butcher XE, et al. The COVID-19 citizen science study: protocol for a longitudinal digital health cohort. JMIR Res Protoc, 2021; 10(8):e28169.

A Patient-Centered PaTH to Addressing Diabetes

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: The PaTH to Health: Diabetes Study
ClinicalTrials.gov#: NCT02788903
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement
Principal Investigator: Jennifer Kraschnewski
Site Name: Pennsylvania State University
PCORnet® Network Partner: PaTH
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2016
Study Duration: 2016 – 2021
Participating Clinical Research Networks: GPC, PaTH
Therapeutic Area: Metabolic Disorders
Condition: COVID-19; Diabetes; Obesity
Population: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):

  1. How often is intensive behavioral therapy (IBT) being utilized in primary care and how has it impacted weight and diabetes outcomes for patients with and at-risk of type 2 diabetes?
  2. What is the impact of telemedicine utilization during the COVID-19 pandemic for patients with and at-risk of type 2 diabetes?
  3. What are demographic and clinical characteristics associated with severe COVID-19 outcomes across multiple phases of the COVID pandemic for patients with or at-risk of type 2 diabetes?

Primary Publication(s):
A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling
Kraschnewski JL, Kong L, Francis E, Yeh HC, Bryce C, Poger J, Lehman E. A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling. JMIR Res Protoc. 2019 Apr 4;8(4):e12054. doi: 10.2196/12054. PubMed PMID: 30946024

ACTIV-6: COVID-19 Study of Repurposed Medications

Posted on by Jodi Snare

Study Updated 03/28/2024

Study Website: The Activ-6 Study
ClinicalTrials.gov#: NCT04885530
Study Design: Interventional
PCORnet Infrastructure: Collaboration, Engagement, Single IRB
Principal Investigator: Adrian Hernandez
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: NIH
Funding Date: 2021
Study Duration: 2021 – 2024
Participating Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Condition: COVID-19
Population: 30 Years and older (Adult, Older Adult)
Status: Recruiting

Research Question(s):
Can repurposed medications reduce symptoms of non-hospitalized participants with mild to moderate COVID-19?

Primary Publication(s):
Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19
Naggie S, Boulware DR, Lindsell CJ, et al. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022;328(16):1595–1603. doi:10.1001/jama.2022.18590

Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19
McCarthy MW, Naggie S, Boulware DR, et al. Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2023;329(4):296–305. doi:10.1001/jama.2022.24100