Ivabradine and IVIG for Long COVID Syndrome (RECOVER-AUTO Trial)

Phase 2

Recruiting

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)

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.

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.

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.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to follow-up (ivig 12 months, ivabradine 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total number of participants enrolled in each Appendix

Secondary study objectives

Change in 6-min Walk Test

Change in Active Stand Test

Change in Composite Autonomic Symptoms Score 31 (COMPASS-31)

+10 more

Other study objectives

Change in PASC Symptom Questionnaire

Change in Vanderbilt Orthostatic Symptoms Score (VOSS)

Changes in Autonomic Function Testing

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.

Do I qualify?Apply below to find out