ACTIVE_NOT_RECRUITING

RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

Official Title

RECOVER-AUTONOMIC (IVIG): Randomized Trial of the Effect of IVIG Versus Placebo on Long COVID Symptoms

Quick Facts

Study Start:2024-03-11
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06305793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * See NCT06305780 for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)
  1. * See NCT06305780 for RECOVER-AUTO: Platform Protocol level exclusion criteria which applies to this appendix (or sub-study)

Contacts and Locations

Principal Investigator

Christopher Grainger, MD
STUDY_CHAIR
Duke Clinical Research Institute
Cyndya Shibao, MD
STUDY_CHAIR
Vanderbilt University Medical Center
Peter Novak, MD
STUDY_CHAIR
Harvard
Pam Taub, MD
STUDY_CHAIR
University of California, San Diego
Tae Chung, MD
STUDY_CHAIR
Johns Hopkins University

Study Locations (Sites)

All sites listed under NCT06305780
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Kanecia Obie Zimmerman

  • Christopher Grainger, MD, STUDY_CHAIR, Duke Clinical Research Institute
  • Cyndya Shibao, MD, STUDY_CHAIR, Vanderbilt University Medical Center
  • Peter Novak, MD, STUDY_CHAIR, Harvard
  • Pam Taub, MD, STUDY_CHAIR, University of California, San Diego
  • Tae Chung, MD, STUDY_CHAIR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-11
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2024-03-11
Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

  • PASC
  • POTS

Additional Relevant MeSH Terms

  • Long COVID
  • Long Coronavirus Disease 2019 (Covid19)
  • Long Covid-19