Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS (POTS)
Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome
About this trial
This is an interventional treatment trial for Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome focused on measuring Tachycardia Post-COVID, Postural Orthostatic Tachycardia Syndrome efgartigimod
Eligibility Criteria
Inclusion Criteria: The participant has completed the ARGX-113-2104 study without permanent discontinuation of IMP and agrees to directly roll over into the extension study without discontinuation of IMP. The participant signs the informed consent form, and can comply with OLE study (ARGX-113-2105) protocol requirements. The participant agrees to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Contraceptive requirements are provided. Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP. Exclusion Criteria: The participant has a clinically significant condition, based on the judgement of the Study Investigator, eg, laboratory abnormalities, 12-lead ECG readings, concomitant medical disease(s), etc., which may place them at undue risk or confound interpretation of study data. The participant intends to become pregnant or start breastfeeding during the study.
Sites / Locations
- North Shore University HealthSystemRecruiting
Arms of the Study
Arm 1
Experimental
Efgartigimod
Receive efgartigimod IV 10mg/kg infusions during a treatment period of 48 weeks