Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS (NCT05633407) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS
United States53 participantsStarted 2022-09-23
Plain-language summary
The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in participants with post-COVID-19 postural orthostatic tachycardia syndrome (POTS) (post-COVID-19 POTS).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Reached the age of consent when signing the informed consent form
✓. Capable of providing signed informed consent and complying with protocol requirements
✓. Diagnosed with new-onset POTS post-COVID-19 established by the following:
✓. History of COVID-19 based on a previous positive test result from either laboratory-confirmed COVID-19 test (eg, a PCR test) or non-laboratory-confirmed COVID-19 test (eg, rapid antigen test); this positive result may be either documented or patient-reported
✓. Tilt table or orthostatic vital sign measurements during screening consistent with consensus criteria: sustained HR increase of ≥30 bpm within 10 min of standing or head up tilt (≥40 bpm for individuals aged 18 to 19 years) and/or HR reaching \>120 bpm within 10 min; absence of sustained 20 mmHg decrease in systolic blood pressure (SBP)
✓. Ongoing symptoms of POTS confirmed by the investigator with at least 3 symptoms in each of the following areas lasting longer than 12 weeks after either diagnosis of COVID-19 or after hospital discharge for COVID-19:
✓. COMPASS 31 ≥35 at screening
✓. Agree to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies and the following:
Exclusion criteria
✕. Diagnosis of or receiving treatment for the following conditions before COVID-19: peripheral neuropathy, POTS, myalgic encephalomyelitis encephalitis/chronic fatigue syndrome, Ehlers Danlos syndrome confirmed by genetic testing, autonomic neuropathy, multiple sclerosis, stroke, spinal cord injury, or any known lesions in the central nervous system by imaging or neurological exam
What they're measuring
1
Change From Baseline to Week 24 in the COMPASS 31 (2-week Recall Version)
Timeframe: Baseline (Day 1) and Week 24
2
Change From Baseline to Week 24 in the MaPS
Timeframe: Baseline (Day 1) and Week 24
3
Number of Participants With TEAEs and TESAEs
Timeframe: From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 236 days
✕. History of or currently being treated for clinically significant ongoing cardiac arrythmia, heart failure, myocarditis, pulmonary embolism requiring anticoagulation, pulmonary fibrosis, or critical illness-related polyneuropathy or myopathy
✕. Known autoimmune disease that, in the investigator's judgment, would interfere with an accurate assessment of clinical symptoms of post-COVID-19 POTS or puts the participant at undue risk
✕. Known HIV disease or common variable immunodeficiency
✕. History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP. Adequately-treated participants with the following cancers may be included at any time: