Intervention

ACTIV-6: COVID-19 Study of Repurposed Medications

Posted on by Jodi Snare

Page last updated May 11, 2026

ClinicalTrials.gov#: NCT04885530
Study Design: Intervention Trial
PCORnet Infrastructure: Single IRB, Patient partners or engagement
Principal Investigator: Adrian Hernandez
Institution: Duke Clinical Research Institute
PCORnet® Network Partner: The Coordinating Center for PCORnet®
Funder: Federal (NIH)
Funding Date: 2021
Study Duration: 2021 – 2025
Participating PCORnet® Clinical Research Networks: GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Infectious Disease
Condition: COVID-19
Age Range: 30 Years and older (Adult, Older Adult)
Status: Active, not recruiting

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

Primary Publication(s):

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

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

Naggie S, Boulware DR, Lindsell CJ, et al. Effect of Higher-Dose Ivermectin for 6 Days vs Placebo on Time to Sustained Recovery in Outpatients With COVID-19: A Randomized Clinical Trial. JAMA. 2023;329(11):888–897. doi:10.1001/jama.2023.1650

Biologic Abatement and Capturing Kids’ Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)

Posted on by Jodi Snare

Page last updated May 11, 2026

Study Website: The BACK-OFF JSpA Study
ClinicalTrials.gov#: NCT04891640
Study Design: Intervention Trial
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Pamela F. Weiss
Institution: The Children's Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2020
Study Duration: 2021 – 2026
Participating PCORnet® Clinical Research Networks: GPC, OneFlorida+, PaTH, PEDSnet, STAR
Therapeutic Area: Autoimmune (Allergy & Immunology), Spondyloarthritis
Condition: Juvenile Spondyloarthritis
Age Range: 8 Years to 21 Years (Child,  Adult)
Status: Active, not recruiting

Research Question(s):

This trial will compare how patients with inactive spondyloarthritis on tumor necrosis factor inhibitor (TNFi) treatment respond to three treatment options that doctors currently use:

  • Continue standard TNFi medication,
  • Space out the time between usual TNFi medication doses, or
  • Stop the TNFi medication. If we can safely prolong the time between doses or completely take away TNFi therapy in this population, we may remove unnecessary medication exposure, improve patient quality of life, and lower medication costs.

Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA)

Posted on by Jodi Snare

Page last updated October 29, 2025

Study Website: CaRISMA
ClinicalTrials.gov#: NCT04419168
Study Design: Intervention Trial
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Charles Jonassaint
Institution: University of Pittsburgh
PCORnet® Network Partner: PaTH
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2020
Study Duration: 2020 – 2024
Participating PCORnet® Clinical Research Networks: PaTH, STAR
Therapeutic Area: Mental and Behavioral Health
Condition: Chronic Pain; Depression; Anxiety; Opioid Use
Age Range: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):
Does mobile phone-delivered computerized cognitive behavioral therapy provide a greater benefit for daily pain and depression in adult patients with sickle cell disease than digital education?

Primary Publications(s):

Badawy SM, Abebe KZ, Reichman CA, et al. Comparing the effectiveness of education versus digital cognitive behavioral therapy for adults with sickle cell disease: protocol for the cognitive behavioral therapy and real-time pain management intervention for sickle cell via mobile applications (CaRISMA) study. JMIR Res Protoc, 2021; 10(5):e29014. doi:10.2196/29014

Pragmatic Evaluation of Events and Benefits of Lipid-lowering in Older Adults (PREVENTABLE)

Posted on by Jodi Snare

Page last updated April 14, 2026

Study Website: PREVENTABLE
ClinicalTrials.gov#: NCT04262206
Study Design: Intervention Trial
PCORnet Infrastructure: Common Data Model (CDM), Single IRB, Patient partners or engagement
Principal Investigator: Karen Alexander
Institution: Duke Clinical Research Institute
Funder: Federal (NIH); (Project webpage)
Funding Date: 2019
Study Duration: 2020 – 2027
Participating PCORnet® Clinical Research Networks: ADVANCE, GPC, INSIGHT, OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Cognitive Impairment, Mild; Dementia; Cardiovascular Diseases
Age Range: 75 Years and older (Older Adult)
Status: Recruiting

Research Question(s):
Can a statin help prevent dementia and disability in adults aged 75 or older, as well as heart attacks and other cardiovascular-related deaths, while not increasing risks of adverse health outcomes?

Primary Publication(s):

Sachs BC, Rapp SR, Kistler CE, et al. The pragmatic evaluation of events and benefits of lipid-lowering in older adults (PREVENTABLE) trial: study design and procedures for cognitive assessment and adjudication. Alzherimers. Dement., 2021; 17(Supp.9). doi.org/10.1002/alz.054022