Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
177
Countries
3
Sites
6
Post-COVID-19 Postural Orthostatic Tachycardia Syndrome
The primary objective of this study is to evaluate the efficacy of IgPro20 in comparison with placebo in adults with post-COVID POTS.
Key facts
- Sponsor
- CSL Behring LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- completed 11 Jul 2025
- Decision date (initial)
- 2025-05-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508744-22-00
- ClinicalTrials.gov
- NCT06524739
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The primary objective of this study is to evaluate the efficacy of IgPro20 in comparison with placebo in adults with post-COVID POTS.
Conditions and MedDRA coding
Post-COVID-19 Postural Orthostatic Tachycardia Syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10063080 | Postural orthostatic tachycardia syndrome | 100000004849 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Double-blind Treatment Double-blind, multiple doses of either IgPro20 or Placebo
|
Randomised Controlled | Double | [{"id":105007,"code":3,"name":"Monitor"},{"id":105006,"code":2,"name":"Investigator"},{"id":105009,"code":1,"name":"Subject"},{"id":105008,"code":5,"name":"Carer"}] | IgPro20: IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration Placebo: 2% human albumin solution administered subcutaneously as a volume-matched dose to the experimental IMP. |
| 2 | Open-label Treatment Open-label, multiple doses of IgPro20
|
Not Applicable | None | IgPro20: IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at [email protected].
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-508293-28-00 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study | CSL Behring LLC |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Provide written informed consent and be willing and, in the opinion of the investigator, able to adhere to all protocol requirements.
- 2. Males and females aged ≥ 18 at the time of providing written informed consent.
- 3. Diagnosis of post-COVID POTS, defined by both a preceding COVID-19 infection based on confirmed historical documentation and onset of POTS symptoms developing within 4 months after COVID-19 infection as defined per consensus criteria.
- 4. COMPASS-31 score of at least 40 at the Screening visit.
- 5. Positive confirmatory standardized standing test (ie, HR increase of ≥ 30 bpm [≥ 40 bpm for participants aged 18 to 19 years] within 10 minutes in the absence of orthostatic hypotension) at the Screening visit.
Exclusion criteria 4
- 1. Treatment with Immunoglobulin G (IgG) or plasmapheresis within 12 weeks before Screening
- 2. Symptoms and / or diagnosis of or receiving treatment for POTS before COVID-19 infection
- 3. Prior diagnosis of or receiving current treatment at Screening for the following conditions (unless onset was related to the inciting POTS-associated COVID-19 infection): certain neurologic, autoimmune, endocrine, cardiac, or other disorders, and pre-existing psychiatric disorders.
- 4. Presence of active infections, including human immunodeficiency virus infection, hepatitis B, hepatitis C, active SARS-CoV-2 infection, or any uncontrolled systemic infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of participants no longer meeting diagnostic criteria of post-COVID POTS as measured by standardized standing test (ie, no longer experiencing HR increase of ≥ 30 bpm, in the absence of 20 mmHg decrease of SBP [orthostatic hypotension])
Secondary endpoints 8
- Change from baseline in orthostatic intolerance score of COMPASS-31
- Change from baseline in COMPASS-31 total score
- Change from baseline in heart rate increase within 10 minutes of standing test
- Number of participants with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs and related serious TEAEs
- Percentage of participants with TEAEs, related TEAEs, serious TEAEs and related serious TEAEs
- Number of participants with electrocardiogram (ECG) abnormalities
- Percentage of participants with ECG abnormalities
- Change from baseline in ECG abnormalities
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hizentra 200 mg/ml solution for subcutaneous injection
PRD912601 · Product
- Active substance
- Human Normal Immunoglobulin
- Substance synonyms
- IMMUNOGLOBULIN HUMAN NORMAL
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 250 ml millilitre(s)
- Max total dose
- 13250 ml millilitre(s)
- Max treatment duration
- 53 Week(s)
- Authorisation status
- Authorised
- ATC code
- J06BA01 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASCULAR ADM.
- Marketing authorisation
- EU/1/11/687/014
- MA holder
- CSL BEHRING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Human Albumin ”CSL Behring”, infusionsvæske, opløsning 5 %
PRD11656034 · Product
- Active substance
- Human Plasma Protein
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 250 ml millilitre(s)
- Max total dose
- 6000 ml millilitre(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- B05AA01 — ALBUMIN
- Marketing authorisation
- 35990
- MA holder
- CSL BEHRING GMBH
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The final placebo product will comprise a 2% human albumin solution. IgPro20 Placebo is manufactured by diluting already released, US licensed CSL Behring Human Albumin 5% (AlbuRx® 5%).
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CSL Behring LLC
- Sponsor organisation
- CSL Behring LLC
- Address
- 1020 1st Avenue
- City
- King Of Prussia
- Postcode
- 19406-1310
- Country
- United States
Scientific contact point
- Organisation
- CSL Behring LLC
- Contact name
- Study Director
Public contact point
- Organisation
- CSL Behring LLC
- Contact name
- Trial Registration Coordinator
Third parties 19
| Organisation | City, country | Duties |
|---|---|---|
| Drugdev Inc. ORG-100047542
|
Wayne, United States | Other |
| CSL Innovation Pty Limited ORG-100051289
|
Melbourne, Australia | Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| MEDPACE LABORATORIES ORG-100042942
|
Leuven, Belgium | Other, Laboratory analysis |
| Advanced Clinical LLC ORG-100047708
|
Deerfield, United States | Code 12, Other |
| Cytel Inc. ORG-100042560
|
Cambridge, United States | Other |
| Advanced Clinical LLC ORG-100047708
|
Deerfield, United States | Other |
| Medical Equipment Supplies And Management Limited ORG-100044212
|
Chorley, United Kingdom | Other |
| Parexel International Corp. ORG-100007310
|
Durham, United States | Other |
| Fisher Clinical Services Inc. ORG-100014726
|
Allentown, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Leapcure Inc. ORL-000003865
|
Redwood City, CA, United States | Other |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Fortrea Inc. ORG-100012602
|
Princeton, United States | Data management, E-data capture |
| Longboat Clinical Limited ORG-100045828
|
Limerick, Ireland | Other |
| Block Clinical Inc. ORG-100048643
|
San Diego, United States | Other |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
| Center For Information And Study On Clinical Research Participation Inc. ORG-100044581
|
Boston, United States | Other |
Locations
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 6 | 1 |
| Italy | Ended | 5 | 2 |
| Spain | Ended | 6 | 3 |
| Rest of world
Canada, United States, United Kingdom
|
— | 160 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2023-508744-22-00_EU CTIS Summary results SUM-126501
|
2026-03-30T17:57:38 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2023-508744-22-00-Lay summary | 2026-03-30T17:57:44 | Submitted | Laypersons Summary of Results |
Documents 120 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 2023-508744-22-00-Lay summary_DE_V2_24Mar26 | 2 |
| Laypersons summary of results (for publication) | 2023-508744-22-00-Lay summary_EN_V2_24Mar26 | 2 |
| Laypersons summary of results (for publication) | 2023-508744-22-00-Lay summary_ESP_V2_24Mar26 | 2 |
| Laypersons summary of results (for publication) | 2023-508744-22-00-Lay summary_ITA_V2_24Mar26 | 2 |
| Protocol (for publication) | D1_Protocol 2023-508744-22-00_Redacted | 1 |
| Protocol (for publication) | D4_Note to File eCOA Handheld_Reminder Icon_En_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing_COMPASS-31_eCOA Tablet_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA COMPASS-31_Tablet_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA COMPASS-31_Tablet_En | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA COMPASS-31_Tablet_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA EQ5D5L_Tablet_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA EQ5D5L_Tablet_En | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA EQ5D5L_Tablet_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA EQ5D5L_Tablet_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_InfusionDiary_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_InfusionDiary_En | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_InfusionDiary_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_InfusionDiary_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_Reminder Icon_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_Reminder Icon_En | 2.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_Reminder Icon_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_Reminder Icon_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_Training Module Optional_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_Training Module_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_Training Module_En | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_Training Module_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_Training Module_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_TrainingModuleOptional_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_TrainingModuleOptional_EN | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Handheld_TrainingModuleOptional_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_OHQ_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_OHQ_En | 0.01 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_OHQ_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_OHQ_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Patient Malmo Symptom Score_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Patient Malmo Symptom Score_En | 0.01 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Patient Malmo Symptom Score_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Patient Malmo Symptom Score_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PGIC_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PGIC_En | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PGIC_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PGIC_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PGIS_DE | 2.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PGIS_En | 2.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PGIS_ES | 2.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PGIS_it | 2.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PROMISCognitiveFunctionSF6a_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PROMISCognitiveFunctionSF6a_En | 0.01 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PROMISCognitiveFunctionSF6a_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_PROMISCognitiveFunctionSF6a_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_SF-12_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_SF-12_En | 0.01 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_SF-12_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_SF-12_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Training Module Optional_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Training Module Optional_En | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Training Module Optional_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Training Module Optional_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Training Module_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Training Module_En | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Training Module_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA Tablet_Training Module_it | 1.00 |
| Protocol (for publication) | D4_Patient facing_eCOA-Handheld-Quick-Start-Card | 1 |
| Protocol (for publication) | D4_Patient facing_WPAI-SHP_eCOA Tablet_DE | 1.00 |
| Protocol (for publication) | D4_Patient facing_WPAI-SHP_eCOA Tablet_En | 1.00 |
| Protocol (for publication) | D4_Patient facing_WPAI-SHP_eCOA Tablet_ES | 1.00 |
| Protocol (for publication) | D4_Patient facing_WPAI-SHP_eCOA Tablet_it | 1.00 |
| Recruitment arrangements (for publication) | K1_Recruitment procedure | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment procedure_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment procedure_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_Consent Navigator_Public | 1 |
| Subject information and informed consent form (for publication) | L1_Block_Data Processor Consent_ESP_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult Main_ITA_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_ESP_Public | 3.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Processing_ITA_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_ESP_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_ITA_Public | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional samples for Future Research_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | 1.2 |
| Subject information and informed consent form (for publication) | L2_Block Participant Convenience Programme - Travel Policy | 2.0 |
| Subject information and informed consent form (for publication) | L2_Block Participant Convenience Programme Intro Letter | 2.0 |
| Subject information and informed consent form (for publication) | L2_Block Participant Convenience Programme Overview | 1.0 |
| Subject information and informed consent form (for publication) | L2_Block Participant Payment Activation Reimbursement and Remittance Details | 1.0 |
| Subject information and informed consent form (for publication) | L2_Block Sample Participant Communications | 2.0 |
| Subject information and informed consent form (for publication) | L2_Consent Navigator_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Data Processor Consent_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_Leapcure AdvocacyMaterials | 1.0 |
| Subject information and informed consent form (for publication) | L2_Leapcure CampaignImagery | 1.0 |
| Subject information and informed consent form (for publication) | L2_Leapcure PrivacyPolicy | 1.0 |
| Subject information and informed consent form (for publication) | L2_Leapcure_ SummaryLetter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Leapcure_CampaignCopy | 1.0 |
| Subject information and informed consent form (for publication) | L2_Leapcure_PatientJourney | 1.0 |
| Subject information and informed consent form (for publication) | L2_Leapcure_Pre-screenerQuestionnaire | 1.0 |
| Subject information and informed consent form (for publication) | L2_Longboat Consent Navigator | 1.0 |
| Subject information and informed consent form (for publication) | L2_Longboat Patient Portal_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Longboat Patient Survey Website | 1.0 |
| Subject information and informed consent form (for publication) | L2_Participant Convenience Programme Intro Letter_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_Participant Convenience Programme Overview_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Participant Convenience Programme Travel Policy_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Participant Payment Activation-Reimbursement and Remittance Details_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient Portal_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Portal_Public | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Survey Website_Public | 1.2 |
| Subject information and informed consent form (for publication) | L2_Patient Survey Website_Public | 1 |
| Subject information and informed consent form (for publication) | L2_Sample Participant Communications_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_Subject ID Card_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_Subject ID Card_Public | 1 |
| Subject information and informed consent form (for publication) | L2_Subject IMP Manual_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Subject IMP Manual_Public | 1 |
| Subject information and informed consent form (for publication) | L2_Thank You Card_Public | 1 |
| Subject information and informed consent form (for publication) | L2_ThankYou Card_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Visit Reminder Card_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_Visit Reminder Card_Public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Hizentra_Not Public | 1 |
| Summary of results (for publication) | 2023-508744-22-00_EU CTIS Summary results | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DE 2023-508744-22-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2023-508744-22-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2023-508744-22-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT 2023-508744-22-00_Redacted | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-10 | Germany | Acceptable 2025-05-05
|
2025-05-07 |