Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: 1. reached the age of consent when signing the informed consent form 2. capable of providing signed informed consent and complying with protocol requirements 3. diagnosed with new-onset pots post-covid-19 established by the following: 1. 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 2. 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) 3. 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: i. vasomotor symptoms: fatigue, orthostatic intolerance, brain fog, exertional dyspnea, difficulty with concentration, venous pooling, and exercise intolerance ii. sympathetic over-compensation symptoms: palpitation, heat intolerance, nausea with or without vomiting, insomnia, anxiety, lack of appetite, chest pain, and diaphoresis 4. compass 31 ≥35 at screening 5. agree to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies and the following: male participants: no male contraception is required female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving imp. contraceptive requirements. 6. body mass index (bmi) \<35 kg/m2

inclusion criteria: 1. reached the age of consent when signing the informed consent form 2. capable of providing signed informed consent and complying with protocol requirements 3. diagnosed with new-onset pots post-covid-19 established by the following: 1. 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 2. 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) 3. 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: i. vasomotor symptoms: fatigue, orthostatic intolerance, brain fog, exertional dyspnea, difficulty with concentration, venous pooling, and exercise intolerance ii. sympathetic over-compensation symptoms: palpitation, heat intolerance, nausea with or without vomiting, insomnia, anxiety, lack of appetite, chest pain, and diaphoresis 4. compass 31 ≥35 at screening 5. agree to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies and the following: male participants: no male contraception is required female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving imp. contraceptive requirements. 6. body mass index (bmi) \<35 kg/m2

May 8, 2024, 8 a.m. usa

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: i. vasomotor symptoms: fatigue, orthostatic intolerance, brain fog, exertional dyspnea, difficulty with concentration, venous pooling, and exercise intolerance ii. sympathetic over-compensation symptoms: palpitation, heat intolerance, nausea with or without vomiting, insomnia, anxiety, lack of appetite, chest pain, and diaphoresis 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: male participants: no male contraception is required female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving imp. contraceptive requirements. body mass index (bmi) <35 kg/m2

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: i. vasomotor symptoms: fatigue, orthostatic intolerance, brain fog, exertional dyspnea, difficulty with concentration, venous pooling, and exercise intolerance ii. sympathetic over-compensation symptoms: palpitation, heat intolerance, nausea with or without vomiting, insomnia, anxiety, lack of appetite, chest pain, and diaphoresis 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: male participants: no male contraception is required female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving imp. contraceptive requirements. body mass index (bmi) <35 kg/m2

Oct. 25, 2023, 4 a.m. usa

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: i. vasomotor symptoms: fatigue, orthostatic intolerance, brain fog, exertional dyspnea, difficulty with concentration, venous pooling, and exercise intolerance ii. sympathetic over-compensation symptoms: palpitation, heat intolerance, nausea with or without vomiting, insomnia, anxiety, lack of appetite, chest pain, and diaphoresis 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: male participants female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving imp. contraceptive requirements. body mass index (bmi) <35 kg/m2

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: i. vasomotor symptoms: fatigue, orthostatic intolerance, brain fog, exertional dyspnea, difficulty with concentration, venous pooling, and exercise intolerance ii. sympathetic over-compensation symptoms: palpitation, heat intolerance, nausea with or without vomiting, insomnia, anxiety, lack of appetite, chest pain, and diaphoresis 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: male participants female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving imp. contraceptive requirements. body mass index (bmi) <35 kg/m2

Dec. 2, 2022, 4 p.m. usa

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: prior covid-19 confirmed by documentation of historical pcr test 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: i. vasomotor symptoms: fatigue, orthostatic intolerance, brain fog, exertional dyspnea, difficulty with concentration, venous pooling, and exercise intolerance ii. sympathetic over-compensation symptoms: palpitation, heat intolerance, nausea with or without vomiting, insomnia, anxiety, lack of appetite, chest pain, and diaphoresis 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: male participants female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving imp. contraceptive requirements. body mass index (bmi) <35 kg/m2

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: prior covid-19 confirmed by documentation of historical pcr test 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: i. vasomotor symptoms: fatigue, orthostatic intolerance, brain fog, exertional dyspnea, difficulty with concentration, venous pooling, and exercise intolerance ii. sympathetic over-compensation symptoms: palpitation, heat intolerance, nausea with or without vomiting, insomnia, anxiety, lack of appetite, chest pain, and diaphoresis 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: male participants female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving imp. contraceptive requirements. body mass index (bmi) <35 kg/m2