Long COVIDPhase 2NCT06305780
RECOVER-AUTONOMIC Platform Protocol
A Phase 2 study testing IVIG + Coordinated Care and Ivabradine + Coordinated Care in people with Long COVID and Long Covid19, run by Kanecia Obie Zimmerman at 50 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID, Long Covid19, Long Covid-19
- What is being tested?
- IVIG + Coordinated Care and Ivabradine + Coordinated Care
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 381 participants
- Where
- 50 sitesUnited States
- Study dates
- 11 Mar 2024to 9 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age at the time of enrollment
- Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization12ɸ ɸ Enrollment of participants with suspected or probable SARS-CoV-2 infection will only be allowed if they occurred before May 1, 2021 and be limited to no more than 10% of the total sample size per Study Drug Appendix. Refer to the Manual of Procedures (MOP) for details.
- Suspected case of SARS-CoV-2 infection - Three options, A through C:
- Meets the clinical OR epidemiological criteria.
- Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia.
- Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Presents with acute respiratory infection with history of fever or measured fever of ≥ 38°C; and cough; with onset within the last 10 days; and who requires hospitalization); or C. Presents with no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 antigen-Rapid Diagnostic Test.
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- Probable case of SARS-CoV-2 infection, defined as meets clinical criteria above AND is a contact of a probable or confirmed case or is linked to a COVID-19 cluster.
- Confirmed case of SARS-CoV-2 infection - Two options, A through B:
- A person with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or B. Meeting clinical criteria AND/OR epidemiological criteria (See suspect case A). With a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.
- Moderate, self-identified autonomic symptoms (defined as COMPASS-31 >20) following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
- OHQ/OIQ, question 1 score >2
Who cannot join
- Known pregnancy, breast-feeding, or contemplating pregnancy during the study period
- Known active acute SARS-CoV-2 infection ≤ 4 weeks from enrollment
- Known renal failure (eGFR <20ml/1.73 m²)
- Known atrial fibrillation or significant cardiac arrhythmia
- Known cardiovascular conditions such as heart failure (Class 3-4), severe valvular disease
- Clinically significant atherosclerotic disease, defined as history of stroke or myocardial infarction or revascularization 6 months prior to enrollment and/or current symptomatic angina
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- Existing uncontrolled hypertension
- Inability to comply with the protocol
- Any condition that the investigator believes makes it inappropriate to treat with study intervention, including severe debility.
- History of POTS or significant dysautonomia before COVID-19 index infection
- Enrolled in another clinical trial or another study intervention appendix in this platform protocol * Patients who are a part of observational studies (e.g. imaging) may be included in this trial. Participants may enroll in another interventional trial or re-enroll in this trial for a different study intervention appendix 30 days after end of study (Follow-up visit).
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
Grady Memorial Hospital - Woodruff Memorial Research - Appendix A & B
Atlanta, Georgia, 30303
Morehouse School of Medicine - Appendix A & B
Atlanta, Georgia, 30310
University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B
Aurora, Colorado, 80045
National Neuromuscular Research Institute - Appendix A & B
Austin, Texas, 78759
Johns Hopkins Hospital - Appendix A Only
Baltimore, Maryland, 21287
Brigham and Women's Hospital - Appendix A Only
Boston, Massachusetts, 02115
University at Buffalo - Appendix A & B
Buffalo, New York, 14203
Vermont Lung Center, University of Vermont - Appendix B Only
Burlington, Vermont, 05405
St. Lawrence Health Medical Campus - Appendix A & B
Canton, New York, 13617
University of Virginia Health System, University Hospital - Appendix A & B
Charlottesville, Virginia, 22908
Rush University Medical Center - Appendix B Only
Chicago, Illinois, 60612
University of Illinois at Chicago - Appendix A & B
Chicago, Illinois, 60612
Cleveland Clinic - Appendix A & B
Cleveland, Ohio, 44195
Southwest Family Medicine Associates - Appendix A & B
Dallas, Texas, 75235
Henry Ford Hospital - Appendix A & B
Detroit, Michigan, 48202
Duke University Hospital - Appendix A & B
Durham, North Carolina, 27710
NorthShore University HealthSystem - Evanston Hospital - Appendix B Only
Evanston, Illinois, 60201
University of Kansas Medical Center CTSU Fairway - Appendix A & B
Fairway, Kansas, 66205
University of Florida Health - Appendix A & B
Gainesville, Florida, 32610
East Carolina University - Appendix B Only
Greenville, North Carolina, 27834
Queens Medical Center - Appendix B Only
Honolulu, Hawaii, 96813
University of Texas Health Science Center at Houston
Houston, Texas, 78701
Marshall Health - University Physicians and Surgeons - Appendix A & B
Huntington, West Virginia, 25701
University of Iowa - Appendix A & B
Iowa City, Iowa, 52242
University of Mississippi Medical Center - Appendix A & B
Jackson, Mississippi, 39216
Evergreen Hospital Medical Center - Appendix A & B
Kirkland, Washington, 98034
University of California San Diego - Appendix B Only
La Jolla, California, 92307
Lakeland Regional Medical Center - Appendix A & B
Lakeland, Florida, 33805
University of Kentucky Medical Center - Appendix A & B
Lexington, Kentucky, 40536
University of Arkansas for Medical Sciences - Appendix A & B
Little Rock, Arkansas, 72205
Cedars Sinai Medical Center - Appendix A & B
Los Angeles, California, 90048
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University Medical Center New Orleans - Appendix A & B
New Orleans, Louisiana, 70112
Columbia University Irving Medical Center - Appendix A & B
New York, New York, 10032
Sentara Norfolk General Hospital - Appendix A & B
Norfolk, Virginia, 23507
University of Oklahoma Health Science Center - Oklahoma Clinical and Translational Science Institute - Appendix A & B
Oklahoma City, Oklahoma, 73104
East Alabama Medical Center - Appendix B Only
Opelika, Alabama, 36801
Innovation Clinical Trials Inc.- Appendix A & B
Palmetto Bay, Florida, 33157
Kent Hospital - Appendix A & B
Pawtucket, Rhode Island, 02860
Center for Complex Neurology - Appendix A & B
Phoenix, Arizona, 85006
Oregon Health and Science University - Appendix A & B
Portland, Oregon, 97239
Mayo Clinic - Appendix A & B
Rochester, Minnesota, 55905
Bateman Horne Center - Appendix B Only
Salt Lake City, Utah, 84102
University of Texas Health Science Center at San Antonio - Appendix A & B
San Antonio, Texas, 78229
Providence Medical Research Center - Appendix A & B
Spokane, Washington, 99204
Washington University School of Medicine - Appendix B Only
St Louis, Missouri, 63110
Stanford University - Appendix B Only
Stanford, California, 94305
Stony Brook University Hospital - Appendix A & B
Stony Brook, New York, 11794
Montefiore Medical Center - Moses Campus - Appendix B
The Bronx, New York, 10467
MedStar National Rehabilitation Hospital - Appendix B only
Washington D.C., District of Columbia, 20010
About this study
Official title: RECOVER-AUTONOMIC: A Platform Protocol for Evaluation of Interventions for Autonomic Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
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 PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.
Read the detailed description
The hypothesis is that some of the autonomic dysfunction symptoms are immune-mediated, so immunotherapy and other applicable therapies will result in improvement in autonomic symptoms.
Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.
- Conditions
- Long COVID, Long Covid19, Long Covid-19
- Being tested
- IVIG + Coordinated Care, IVIG Placebo + Coordinated Care, Ivabradine + Coordinated Care, Ivabradine Placebo + Coordinated Care, IVIG + Usual Care
- Keywords
- PASC, POTS
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIG + Coordinated CareDrug
Participants will receive IVIG for a duration of 9 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with IVIG administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through a care coordinator.
IVIG Placebo + Coordinated CareDrug
Normal saline given intravenously will be the control (placebo) product. Blinding IV bag and tubing covers will be used for both IVIG and Placebo administration.
Participants will receive IVIG placebo for a duration of 9 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with IVIG placebo administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through a care coordinator.
Ivabradine + Coordinated CareDrug
Participants will receive Ivabradine for a duration of 3 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with ivabradine administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through care coordinator.
Ivabradine Placebo + Coordinated CareDrug
The control (placebo) oral tablets will be similar to the study drug, ivabradine.
The control packaging matches the packaging.
Participants will receive Ivabradine placebo for a duration of 3 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with ivabradine placebo administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, feedback, nutrition counseling, motivation, education, and assisted care through care coordinator.
IVIG + Usual CareDrug
Participants will receive IVIG for a duration of 9 months and usual non-pharmacologic care (control) for a duration of 3 months. This will be concurrent with scheduled IVIG administration.
IVIG Placebo + Usual CareDrug
Normal saline given intravenously will be the control (placebo) product. The normal saline will be of similar formulation and appearance to IVIG.
Participants will receive IVIG placebo for a duration of 9 months and usual non-pharmacologic care (control) for a duration of 3 months. This will be concurrent with scheduled IVIG placebo administration.
Ivabradine + Usual CareDrug
Participants will receive Ivabradine for a duration of 3 months and usual non-pharmacologic care (control) for a duration of 3 months, concurrent with ivabradine administration.
Ivabradine Placebo + Usual CareDrug
The control (placebo) oral tablets will be similar to the study drug, ivabradine.
The control packaging matches the packaging.
Participants will receive Ivabradine placebo for a duration of 3 months and usual non-pharmacologic care (control) for a duration of 3 months, concurrent with ivabradine placebo administration.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous immunoglobulin (IVIG) | Experimental | 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. Receives: Drug: IVIG + Coordinated Care; Drug: IVIG Placebo + Coordinated Care; Drug: IVIG + Usual Care; Drug: IVIG Placebo + Usual Care |
| Ivabradine | Experimental | 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. Receives: Drug: Ivabradine + Coordinated Care; Drug: Ivabradine Placebo + Coordinated Care; Drug: Ivabradine + Usual Care; Drug: Ivabradine Placebo + Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Participants Enrolled in Each Appendix
Measured: During the enrollment period, approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start11 Mar 2024
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanecia Obie Zimmerman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kanecia Obie Zimmerman, Duke University
- Investigators
- Christopher Granger, MD, Study chair, Duke Clinical Research InstituteCyndya Shibao, MD, Study chair, Vanderbilt University Medical CenterPeter Novak, MD, Study chair, HarvardPam Taub, MD, Study chair, University of California, San DiegoTae Chung, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305780
- Sponsor's protocol ID
- Pro00112597
- Other IDs
- OTA-21-015G
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2024
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The summary of results will be shared on the study website: https://recovercovid.org/
Publications
Fudim M, Novak P, Taub PR, Chung T, Zimmerman KO, Moy OV, Fissler HZ, Wen J, Freeman NLB, O'Brien S, Marti H, Cook D, Low P, Kim DY, Rosenberg Y, Granger CB, Shibao CA. Design and rationale of RECOVER-AUTONOMIC: A randomized platform trial evaluating interventions for Long COVID postural orthostatic tachycardia syndrome. Am Heart J. 2026 Jun;296:107384. doi: 10.1016/j.ahj.2026.107384. Epub 2026 Feb 18.
PubMed 41720282
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECOVER-AUTONOMIC: A Platform Protocol for Evaluation of Interventions for Autonomic Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
- ClinicalTrials.gov ID
- NCT06305780
- Acronym / sponsor ID
- Pro00112597
- Conditions
- Long COVID, Long Covid19, Long Covid-19
- Keywords
- PASC, POTS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Kanecia Obie ZimmermanUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Posted 3 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.
Detailed description
The hypothesis is that some of the autonomic dysfunction symptoms are immune-mediated, so immunotherapy and other applicable therapies will result in improvement in autonomic symptoms.
Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention.
| Arm | Type | Receives |
|---|---|---|
| Intravenous immunoglobulin (IVIG) | Experimental | Drug: IVIG + Coordinated Care, Drug: IVIG Placebo + Coordinated Care, Drug: IVIG + Usual Care, Drug: IVIG Placebo + Usual CareIn 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 | Experimental | Drug: Ivabradine + Coordinated Care, Drug: Ivabradine Placebo + Coordinated Care, Drug: Ivabradine + Usual Care, Drug: Ivabradine Placebo + Usual CareIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 18 years of age at the time of enrollment
- Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization12ɸ ɸ Enrollment of participants with suspected or probable SARS-CoV-2 infection will only be allowed if they occurred before May 1, 2021 and be limited to no more than 10% of the total sample size per Study Drug Appendix. Refer to the Manual of Procedures (MOP) for details.
- Probable case of SARS-CoV-2 infection, defined as meets clinical criteria above AND is a contact of a probable or confirmed case or is linked to a COVID-19 cluster.
- Moderate, self-identified autonomic symptoms (defined as COMPASS-31 >20) following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent
- OHQ/OIQ, question 1 score >2
Key exclusion criteria (11 listed)
- Known pregnancy, breast-feeding, or contemplating pregnancy during the study period
- Known active acute SARS-CoV-2 infection ≤ 4 weeks from enrollment
- Known renal failure (eGFR <20ml/1.73 m²)
- Known atrial fibrillation or significant cardiac arrhythmia
- Known cardiovascular conditions such as heart failure (Class 3-4), severe valvular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIG + Coordinated CareParticipants will receive IVIG for a duration of 9 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with IVIG administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through a care coordinator. | Drug | Intravenous immunoglobulin (IVIG) |
| IVIG Placebo + Coordinated CareNormal saline given intravenously will be the control (placebo) product. Blinding IV bag and tubing covers will be used for both IVIG and Placebo administration. Participants will receive IVIG placebo for a duration of 9 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with IVIG placebo administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through a care coordinator. | Drug | Intravenous immunoglobulin (IVIG) |
| Ivabradine + Coordinated CareParticipants will receive Ivabradine for a duration of 3 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with ivabradine administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, motivation, education, and assisted care through care coordinator. | Drug | Ivabradine |
| Ivabradine Placebo + Coordinated CareThe control (placebo) oral tablets will be similar to the study drug, ivabradine. The control packaging matches the packaging. Participants will receive Ivabradine placebo for a duration of 3 months and coordinated non-pharmacologic care for a duration of 3 months, concurrent with ivabradine placebo administration. Coordinated non-pharmacologic care involves volume expansion through high salt diet, water intake, abdominal binder, exercise/rehabilitation, feedback, nutrition counseling, motivation, education, and assisted care through care coordinator. | Drug | Ivabradine |
| IVIG + Usual CareParticipants will receive IVIG for a duration of 9 months and usual non-pharmacologic care (control) for a duration of 3 months. This will be concurrent with scheduled IVIG administration. | Drug | Intravenous immunoglobulin (IVIG) |
| IVIG Placebo + Usual CareNormal saline given intravenously will be the control (placebo) product. The normal saline will be of similar formulation and appearance to IVIG. Participants will receive IVIG placebo for a duration of 9 months and usual non-pharmacologic care (control) for a duration of 3 months. This will be concurrent with scheduled IVIG placebo administration. | Drug | Intravenous immunoglobulin (IVIG) |
| Ivabradine + Usual CareParticipants will receive Ivabradine for a duration of 3 months and usual non-pharmacologic care (control) for a duration of 3 months, concurrent with ivabradine administration. | Drug | Ivabradine |
| Ivabradine Placebo + Usual CareThe control (placebo) oral tablets will be similar to the study drug, ivabradine. The control packaging matches the packaging. Participants will receive Ivabradine placebo for a duration of 3 months and usual non-pharmacologic care (control) for a duration of 3 months, concurrent with ivabradine placebo administration. | Drug | Ivabradine |
Primary outcome
Total Number of Participants Enrolled in Each Appendix
Time frame: During the enrollment period, approximately 16 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41720282Fudim M, Novak P, Taub PR, Chung T, Zimmerman KO, Moy OV, Fissler HZ, Wen J, Freeman NLB, O'Brien S, Marti H, Cook D, Low P, Kim DY, Rosenberg Y, Granger CB, Shibao CA. Design and rationale of RECOVER-AUTONOMIC: A randomized platform trial evaluating interventions for Long COVID postural orthostatic tachycardia syndrome. Am Heart J. 2026 Jun;296:107384. doi: 10.1016/j.ahj.2026.107384. Epub 2026 Feb 18.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. The summary of results will be shared on the study website: https://recovercovid.org/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Granger, MD study chair
Duke Clinical Research Institute
Cyndya Shibao, MD study chair
Vanderbilt University Medical Center
Peter Novak, MD study chair
Harvard
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IVIG + Coordinated Care and Ivabradine + Coordinated Care in people with Long COVID and Long Covid19, run by Kanecia Obie Zimmerman at 50 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Participants Enrolled in Each Appendix (time frame: During the enrollment period, approximately 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06305780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.