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Monoclonal Antibodies

IVIG + Coordinated Care for COVID-19 (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 (12 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 with COVID-19 treatment plans. It is looking at ways to treat symptoms like cardiovascular issues and postural orth

Who is the study for?

This trial is for individuals who have had COVID-19 and are now experiencing autonomic dysfunction symptoms like rapid heartbeat when standing (POTS). Participants must show an abnormal increase in heart rate upon standing, have a specific score on a questionnaire assessing autonomic symptoms (COMPASS-31 > 40), and meet the general criteria listed under NCT########.Check my eligibility

What is being tested?

The study is testing different treatments for post-COVID complications affecting the nervous system. It includes IVIG (a blood product used to treat immune deficiencies), a placebo version of IVIG, coordinated care involving multiple healthcare providers, and usual care that patients typically receive.See study design

What are the potential side effects?

IVIG can cause side effects such as headache, muscle pain, fever or chills. Some people might also experience allergic reactions or skin irritation at the infusion site. The exact side effects will depend on individual health conditions.

RECOVER-AUTO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to follow-up (12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to follow-up (12 months)

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

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 more

Other outcome measures

Change in PASC Symptom Questionnaire

Change in Vanderbilt Orthostatic Symptoms Score (VOSS)

Changes in Autonomic Function Testing

RECOVER-AUTO Trial Design

4Treatment groups

Experimental Treatment

Group I: IVIG Placebo + Usual CareExperimental Treatment2 Interventions

Saline: Same dosage as IVIG; monthly for 9 months (36 weeks)

Group II: IVIG Placebo + Coordinated CareExperimental Treatment2 Interventions

Saline: Same dosage as IVIG; monthly for 9 months (36 weeks)

Group III: IVIG + Usual CareExperimental Treatment2 Interventions

IVIG (Gamunex); 2g /kg monthly for 9 months (36 weeks)

Group IV: IVIG + Coordinated CareExperimental Treatment2 Interventions

IVIG (Gamunex); 2g /kg monthly for 9 months (36 weeks)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Coordinated Care

2011

N/A

~640

Usual Care

1990

Completed Phase 4

~7700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,365 Previous Clinical Trials

3,420,440 Total Patients Enrolled

50 Trials studying COVID-19

355,963 Patients Enrolled for COVID-19

Kanecia Obie ZimmermanLead Sponsor

8 Previous Clinical Trials

2,977 Total Patients Enrolled

2 Trials studying COVID-19

560 Patients Enrolled for COVID-19

Pam Taub, MDStudy ChairUniversity of California, San Diego

8 Previous Clinical Trials

976 Total Patients Enrolled

2 Trials studying COVID-19

560 Patients Enrolled for COVID-19

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 positions for patients in this ongoing clinical trial?

"As per the information available on clinicaltrials.gov, recruitment for this particular trial is currently closed. The study was initially posted on March 1st, 2024 and underwent its latest update on March 18th, 2024. Despite the closure of this trial, there are approximately 601 alternative studies actively seeking participants at present."

Answered by AI

What is the level of risk associated with combining IVIG and Coordinated Care for individuals?

"The safety assessment for IVIG + Coordinated Care has been rated at 2 by our team at Power, indicating a moderate level of safety. This determination is based on the Phase 2 trial status, where some data exists to support safety but not yet efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kanecia Obie Zimmerman 2024. "RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06305793.

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