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IVIG for Long COVID Syndrome (RECOVER-AUTO Trial)
Phase 2
Waitlist Available
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to follow-up (ivig 12 months, ivabradine 6 months)
Awards & highlights
RECOVER-AUTO Trial Summary
This trial is a flexible study that can be used in different healthcare and community settings to help treat autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (
Who is the study for?
Adults over 18 with long COVID symptoms like fever, cough, fatigue, and more for at least 12 weeks post-infection. Participants must have had a confirmed or suspected case of COVID-19 before May 1, 2021. Severe autonomic dysfunction patients are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Ivabradine and IVIG (an immune therapy) against placebos in managing long COVID symptoms related to the nervous system. It includes usual care and coordinated care approaches in different combinations.See study design
What are the potential side effects?
Ivabradine may cause slow heart rate, high blood pressure, blurred vision or brightness in the visual field; IVIG might lead to mild flu-like symptoms, headache, nausea or severe reactions like kidney damage or blood clots.
RECOVER-AUTO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to follow-up (ivig 12 months, ivabradine 6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to follow-up (ivig 12 months, ivabradine 6 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score
Secondary outcome measures
Change in 6-min Walk Test
Change in Active Stand Test
Change in Composite Autonomic Symptoms Score 31 (COMPASS-31)
+10 moreOther outcome measures
Change in PASC Symptom Questionnaire
Change in Vanderbilt Orthostatic Symptoms Score (VOSS)
Changes in Autonomic Function Testing
RECOVER-AUTO Trial Design
2Treatment groups
Experimental Treatment
Group I: IvabradineExperimental Treatment4 Interventions
In the ivabradine study, randomization will be implemented with 1:1:1:1 allocation among the combinations of ivabradine/placebo and coordinated/usual care. All participants receive either ivabradine or placebo for 3 months (12 weeks) with a follow-up period for an additional 3 months (total study duration of 6 months). See NCT06305806 for additional details.
Group II: IVIGExperimental Treatment4 Interventions
In the IVIG study, randomization will be implemented with 1:1:1:1 allocation among the combination of IVIG/placebo and coordinated/ usual non-pharmacologic care. All participants will receive IVIG or placebo for 9 months (36 weeks) with a follow-up period for an additional 3 months (total study duration for 12 months). See NCT06305793 for additional details.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,365 Previous Clinical Trials
3,420,260 Total Patients Enrolled
Kanecia Obie ZimmermanLead Sponsor
8 Previous Clinical Trials
2,797 Total Patients Enrolled
Christopher Grainger, MDStudy ChairDuke Clinical Research Institute
2 Previous Clinical Trials
380 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for patient participation in this clinical trial?
"As per clinicaltrials.gov, the current trial is not actively seeking candidates. The study was first listed on 3/1/2024 and last revised on 3/12/2024. While this specific research project is not accepting participants currently, there are 597 alternative trials open for recruitment."
Answered by AI
What is the safety profile of intravenous immunoglobulin for individuals receiving treatment?
"Our evaluation at Power assigns a safety rating of 2 to IVIG on a scale from 1 to 3. This assessment is made in the context of it being a Phase 2 trial, where some evidence supports its safety profile but not yet its effectiveness."
Answered by AI
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