Infectious Disease

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.

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

 

The RECOVER Post-Acute Sequelae of SARS-CoV-2 (PASC) Electronic Health Record (EHR) Cohort Study

Posted on by Jodi Snare

Study Updated 03/05/2024

Study Website: RECOVERCOVID
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Christopher Forrest, L. Charles Bailey, Grace Lee
Site Name: The Children’s Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: NIH
Funding Date: 2021
Study Duration: 2022 – 2025
Participating Clinical Research Networks: ADVANCE, GPC, PaTH, PEDnet, STAR
Therapeutic Area: Infectious Disease
Condition: COVID-19; SARS-CoV-2 Infection
Population: Pediatrics 21 years and younger
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, treat these health effects and prevent future infection?

Primary Publication(s):
Severity of Acute COVID-19 in Children <18 Years Old March 2020 to December 2021
Forrest CB, Burrows EK, Mejias A, et al. Severity of Acute COVID-19 in Children <18 Years Old March 2020 to December 2021. Pediatrics. 2022 Apr 1;149(4):e2021055765. doi:10.1542/peds.2021-055765. PMID: 35322270.

Clinical Features and Burden of Postacute Sequelae of SARS-CoV-2 Infection in Children and Adolescents
Rao S, Lee GM, Razzaghi H, et al. Clinical Features and Burden of Postacute Sequelae of SARS-CoV-2 Infection in Children and Adolescents. JAMA Pediatr. 2022;176(10):1000–1009. doi:10.1001/jamapediatrics.2022.2800

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.

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