Trial Outcomes & Findings for RECOVER-AUTONOMIC Platform Protocol (NCT NCT06305780)
NCT ID: NCT06305780
Last Updated: 2026-08-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
381 participants
Primary outcome timeframe
During the enrollment period, approximately 16 months
Results posted on
2026-08-03
Participant Flow
This is a platform study record. Recruitment period was from March 2024 to July 2025 at 50 sites. Sites were a mix of large institutions and smaller enrolling clinics.
Participants were excluded prior to assignment due to failure to meet eligibility criteria, safety or medical considerations identified during screening, inability to complete required assessments, or withdrawal of consent before randomization.
Participant milestones
| Measure |
Intravenous Immunoglobulin (IVIG)
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.
|
Ivabradine
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.
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
181
|
|
Overall Study
COMPLETED
|
200
|
181
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RECOVER-AUTONOMIC Platform Protocol
Baseline characteristics by cohort
| Measure |
IVIG
n=200 Participants
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.
|
Ivabradine
n=181 Participants
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.
|
Total
n=381 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 10.99 • n=20 Participants
|
39.6 years
STANDARD_DEVIATION 13.05 • n=20 Participants
|
38.8 years
STANDARD_DEVIATION 12.02 • n=40 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=20 Participants
|
153 Participants
n=20 Participants
|
313 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
68 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
176 Participants
n=20 Participants
|
130 Participants
n=20 Participants
|
306 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
46 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=20 Participants
|
163 Participants
n=20 Participants
|
331 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: During the enrollment period, approximately 16 monthsOutcome measures
| Measure |
IVIG
n=200 Participants
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.
|
Ivabradine
n=181 Participants
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.
|
|---|---|---|
|
Total Number of Participants Enrolled in Each Appendix
|
200 Participants
|
181 Participants
|
Adverse Events
Intravenous Immunoglobulin (IVIG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ivabradine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place