Trial · NCT05633407
Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS
NCT05633407, Phase 2, Completed, argenx; results first posted 2025-05-23
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS. Trials, record NCT05633407. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05633407
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS
- NCT number
- NCT05633407
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- argenx
- Conditions
- Postural Orthostatic Tachycardia Syndrome
- Interventions
- Efgartigimod, Placebo
- First posted
- 2022-12-01
- Last updated
- 2025-05-23
- Results first posted
- 2025-05-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 24 in the COMPASS 31 (2-week Recall Version) | Baseline (Day 1) and Week 24 | Composite Autonomic Symptom Score (COMPASS) 31 modified version (2-week recall) is a self-rated questionnaire to evaluate the severity and distribution of autonomic symptoms in various autonomic nerve disorders. It consists of 31 questions in 6 weighted domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal {GI}-mixed upper and diarrhea, bladder, and pupillomotor). A weighted total score of 0 (mild) to 100 (severe) was determined by adding a maximum raw score for each domain. Higher scores indicated a more severe degree of autonomic symptoms. |
| Primary | Change From Baseline to Week 24 in the MaPS | Baseline (Day 1) and Week 24 | The Malmö POTS Symptom Score (MaPS) score is a dedicated POTS symptom scoring questionnaire. The score consists of 12 questions that assess symptom burden related (tachycardia, palpitations, dizziness, presyncope) and unrelated to orthostatic intolerance (GI symptoms, insomnia, concentration difficulties). Participants graded their symptoms for the past 7 days using a visual analog scale ranging from 0 (no symptoms) to 10 (worst possible). The total score was calculated by summing up the items/individual items and range was 0 to 120 points, with higher scores indicating more severe symptoms. |
| Primary | Number of Participants With TEAEs and TESAEs | From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 236 days | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration. |
| Secondary | Percentage of Participants With Improved PGI-S at Week 24 | Baseline (Day 1) and Week 24 | The Patient Global Impression-Severity (PGI-S) is a participant-rated, single-item scale to assess the severity of a health condition. The scale was used to assess the severity of symptoms over the past week (1-week recall) and overall experience of symptoms over the past 2 weeks (2-week recall). Both were rated on a 4-point type Likert scale, with scores ranging from 1 (none), 2 (mild), 3 (moderate), and 4 (severe). Higher scores indicate greater symptom severity. An "improved PGI-S" was defined by a change from baseline of -3, -2 and -1. |
| Secondary | Percentage of Participants With Improved in PGI-C at Week 24 | Baseline (Day 1) and Week 24 | The Patient Global Impression-Change (PGIC) is a single-item scale to capture the participant's perception of a change in their overall symptom severity. Overall change in symptoms was rated on a 7-point Likert scale, with scores ranging from 1 (much better), 2 (somewhat better), 3 (a little better), 4 (no change), 5 (a little worse), 6 (somewhat worse), and 7 (much worse). Higher PGI-C scores signify worse outcome. An "improved PGI-C" was defined by a change from baseline of 1, 2 and 3. |
| Secondary | Change From Baseline to Week 24 in the PROMIS Fatigue Short Form 8a | Baseline (Day 1) and Week 24 | The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a assesses the impact and perceived fatigue during the last 7 days. This validated 8-question scale has 5 response options, with scores ranging from 1 (not at all) to 5 (very much). Total scores ranged from 8 to 40; higher scores indicated higher fatigue levels and were converted to a T-score with a mean of 50 and standard deviation of 10. A decrease in T-score (negative change from baseline) indicated improvement in fatigue. |
| Secondary | Change From Baseline to Week 24 in the PROMIS Cognitive Function Short Form 6a | Baseline (Day 1) and Week 24 | PROMIS Cognitive Function Short Form 6a assesses the frequency of cognitive difficulties experienced in the past 7 days. The questionnaire comprises 6 questions on subjective cognitive difficulties regarding a participant's concentration, memory, language, mental acuity, and perceived changes in cognitive functioning. The participant marks their response on a 5-point Likert scale (1: never and 5: very often). Scores ranged from 6 to 30; higher scores indicated worse perceived cognitive functioning and were converted to a T-score with a mean of 50 and standard deviation of 10. An increase in T-score (positive change from baseline) indicated better cognitive function. |
| Secondary | Percent Change From Baseline in Total IgG Levels at Week 24 | Baseline (Day 1) and Week 24 | Blood samples for immunoglobulin G (IgG) analysis were collected at specified time points. Total IgG concentrations were quantified using validated methods at a central laboratory. |
| Secondary | Serum Concentration of Efgartigimod | Pre-dose and post-dose at Baseline (Day 1), Weeks 1, 4, 12 and at Week 24 | Serum samples were collected at specified timepoints to determine the concentration of efgartigimod. |
| Secondary | Number of Participants With ADAs Against Efgartigimod | Up to Week 24 | Blood samples were collected at specified timepoints to assess anti-drug antibodies (ADAs) against efgartigimod. ADA incidence reported here was defined as total number of participants with treatment-induced and treatment-boosted ADA. Treatment-induced ADA was defined as a baseline negative sample and at least 1 positive post-baseline sample. Treatment-boosted ADA was defined as a baseline positive sample and the titer value increased 4-fold or more compared to baseline. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 24 in the COMPASS 31 (2-week Recall Version) | Baseline (Day 1) and Week 24 | The FAS included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 24 are reported. | score on a scale | MEAN |
| PRIMARY | Change From Baseline to Week 24 in the MaPS | Baseline (Day 1) and Week 24 | The FAS included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 24 are reported. | score on a scale | MEAN |
| PRIMARY | Number of Participants With TEAEs and TESAEs | From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 236 days | The safety analysis set (SAF) included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Improved PGI-S at Week 24 | Baseline (Day 1) and Week 24 | The FAS included all randomized participants who received at least 1 dose of study drug. Only participants with available data at week 24 are included. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Improved in PGI-C at Week 24 | Baseline (Day 1) and Week 24 | The FAS included all randomized participants who received at least 1 dose of study drug. Only participants with data available for week 24 are included. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 24 in the PROMIS Fatigue Short Form 8a | Baseline (Day 1) and Week 24 | The FAS included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 24 are reported. | T-score | MEAN |
| SECONDARY | Change From Baseline to Week 24 in the PROMIS Cognitive Function Short Form 6a | Baseline (Day 1) and Week 24 | The FAS included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 24 are reported. | T-score | MEAN |
| SECONDARY | Percent Change From Baseline in Total IgG Levels at Week 24 | Baseline (Day 1) and Week 24 | The SAF included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 24 are reported. | percent change | MEAN |
| SECONDARY | Serum Concentration of Efgartigimod | Pre-dose and post-dose at Baseline (Day 1), Weeks 1, 4, 12 and at Week 24 | The pharmacokinetic (PK) analysis set included all randomized participants who received at least 1 dose of efgartigimod and had at least 1 measured concentration of efgartigimod at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentration. Only those participants with data collected at specified timepoints are reported. | nanogram (ng)/mL | MEAN |
| SECONDARY | Number of Participants With ADAs Against Efgartigimod | Up to Week 24 | The SAF included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 24 in the COMPASS 31 (2-week Recall Version) | Efgartigimod | -14.369 | Standard Deviation 15.2541 | score on a scale | |
| Change From Baseline to Week 24 in the COMPASS 31 (2-week Recall Version) | Placebo | -15.957 | Standard Deviation 17.2963 | score on a scale | |
| Change From Baseline to Week 24 in the MaPS | Efgartigimod | -23.5 | Standard Deviation 25.87 | score on a scale | |
| Change From Baseline to Week 24 in the MaPS | Placebo | -19.8 | Standard Deviation 27.75 | score on a scale | |
| Number of Participants With TEAEs and TESAEs | Efgartigimod | TEAEs | 31 | Participants | |
| Number of Participants With TEAEs and TESAEs | Placebo | TEAEs | 14 | Participants | |
| Number of Participants With TEAEs and TESAEs | Efgartigimod | TESAEs | 0 | Participants | |
| Number of Participants With TEAEs and TESAEs | Placebo | TESAEs | 0 | Participants | |
| Percentage of Participants With Improved PGI-S at Week 24 | Efgartigimod | 1-week recall | 45.5 | percentage of participants | |
| Percentage of Participants With Improved PGI-S at Week 24 | Placebo | 1-week recall | 53.3 | percentage of participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Efgartigimod | 36 | |
| Overall Study | STARTED | Placebo | 17 | |
| Overall Study | COMPLETED | Efgartigimod | 31 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | NOT COMPLETED | Efgartigimod | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events154
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Efgartigimod | 1 | 36 | 1 |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 17 | 1 |
| other | Tachycardia | Cardiac disorders | Efgartigimod | 2 | 36 | 2 |
| other | Tachycardia | Cardiac disorders | Placebo | 0 | 17 | 0 |
| other | Ear discomfort | Ear and labyrinth disorders | Efgartigimod | 0 | 36 | 0 |
| other | Ear discomfort | Ear and labyrinth disorders | Placebo | 1 | 17 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Efgartigimod | 1 | 36 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 1 | 17 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Efgartigimod | 0 | 36 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 17 | 4 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Efgartigimod | 0 | 36 |
| Total, all-cause mortality | Placebo | 0 | 17 |
| Total, other adverse events | Efgartigimod | 31 | 36 |
| Total, other adverse events | Placebo | 14 | 17 |
| Total, serious adverse events | Efgartigimod | 0 | 36 |
| Total, serious adverse events | Placebo | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Efgartigimod vs Placebo: deaths from any cause | Trial comparisons |
| Efgartigimod vs Placebo: Number of Participants With ADAs Against Efgartigimod | Trial comparisons |
| Efgartigimod vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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