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NCT06305793 · ClinicalTrials.gov registry record · Phase 2
RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)
A Phase 2 study of Long COVID and Long COVID-19, sponsored by Kanecia Obie Zimmerman.
- Active
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06305793: Active Phase 2 study of Long COVID and Long COVID-19, sponsored by Kanecia Obie Zimmerman.
NCT06305793 is a Phase 2 study of Long COVID and Long COVID-19 that is active but no longer recruiting, run by Kanecia Obie Zimmerman. The registered enrollment target is 200 participants, below the 2,184-participant average among 50 other Long COVID trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06305793, a Phase 2 study of Long COVID and Long COVID-19, is active but no longer recruiting, sponsored by Kanecia Obie Zimmerman.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The OHQ / OIQ is a measure of orthostatic intolerance and includes a 6-item symptom assessment (OHSA) and the 4-item Daily Activity Scale (OHDAS). Each item is scored from 0 (none/no interference) to 10 (worst possible/complete interference), describing the preceding week. The OHSA composite score is the average of the first 6 non-zero items and the OHDAS composite score is the average of the last 4 non-zero items. The OHQ/OIQ composite score is the average of the OHSA and OHDAS composite scores
Conditions Studied
Interventions
- BEHAVIORAL Usual Care
- DRUG IVIG (intravenous immunoglobulin)
- DRUG IVIG Placebo
- BEHAVIORAL Coordinated Care
Study Locations (1)
North Carolina
- All sites listed under NCT06305780 - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-03-11 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 2 |
What the registry record for NCT06305793 still lists
NCT06305793 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 2,184-participant average among 50 other Long COVID trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Long COVID appearing as the primary indexed condition, and to 4 interventions - of which Usual Care is the first listed.
NCT06305793 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06305793 about?
NCT06305793 is a clinical study titled "RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)". 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-ar...
What is the current status of trial NCT06305793?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2024-03-11. Estimated completion is 2026-07-01.
What conditions does trial NCT06305793 study?
This clinical trial studies the following conditions: Long COVID, Long COVID-19, Long Coronavirus Disease 2019 (Covid19).
What interventions are being tested in trial NCT06305793?
The interventions under investigation include: Usual Care (BEHAVIORAL), IVIG (intravenous immunoglobulin) (DRUG), IVIG Placebo (DRUG), Coordinated Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT06305793?
This trial is sponsored by Kanecia Obie Zimmerman, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06305793 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06305793's enrollment target sits among peer trials
200 16th of 50 higher than 34 of 50 other Long COVID trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Long COVID trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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