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

* previous admission to the intensive care unit for covid-19-related symptoms * presence of orthostatic hypotension or tachycardia at screening * completion of covid-19 vaccination less than 4 weeks of baseline (i.e., 4 weeks after the second dose of a two-dose vaccine or 4 weeks after a single dose vaccine) * use of therapies to treat covid-19 symptoms such as remdesivir, dexamethasone (or any other corticosteroid), or convalescent plasma within 14 days of baseline * use of concomitant medications that are sedating * screening lab abnormalities that may cause fatigue such as severe anemia or hypocalcaemia * history of anaphylaxis to a medication, diet, or environmental exposure such as bee sting * previous diagnosis of chronic fatigue syndrome, fibromyalgia, lupus, sjogren's syndrome, or postural orthostatic tachycardia syndrome (pots) * previous diagnosis of sleep apnea * participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from baseline * the presence of a clinically significant infection in the judgement of the investigator, within seven days of baseline * positive test for hepatitis b, c, or hiv at screening * positive pregnancy test at screening or baseline * female subjects currently pregnant or breast feeding at baseline * inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the investigator, would make the subject unsuitable for study participation

* previous admission to the intensive care unit for covid-19-related symptoms * presence of orthostatic hypotension or tachycardia at screening * completion of covid-19 vaccination less than 4 weeks of baseline (i.e., 4 weeks after the second dose of a two-dose vaccine or 4 weeks after a single dose vaccine) * use of therapies to treat covid-19 symptoms such as remdesivir, dexamethasone (or any other corticosteroid), or convalescent plasma within 14 days of baseline * use of concomitant medications that are sedating * screening lab abnormalities that may cause fatigue such as severe anemia or hypocalcaemia * history of anaphylaxis to a medication, diet, or environmental exposure such as bee sting * previous diagnosis of chronic fatigue syndrome, fibromyalgia, lupus, sjogren's syndrome, or postural orthostatic tachycardia syndrome (pots) * previous diagnosis of sleep apnea * participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from baseline * the presence of a clinically significant infection in the judgement of the investigator, within seven days of baseline * positive test for hepatitis b, c, or hiv at screening * positive pregnancy test at screening or baseline * female subjects currently pregnant or breast feeding at baseline * inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the investigator, would make the subject unsuitable for study participation

Oct. 1, 2021, 9 a.m. usa

- previous admission to the intensive care unit for covid-19-related symptoms - presence of orthostatic hypotension or tachycardia at screening - completion of covid-19 vaccination less than 4 weeks of baseline (i.e., 4 weeks after the second dose of a two-dose vaccine or 4 weeks after a single dose vaccine) - use of therapies to treat covid-19 symptoms such as remdesivir, dexamethasone (or any other corticosteroid), or convalescent plasma within 14 days of baseline - use of concomitant medications that are sedating - screening lab abnormalities that may cause fatigue such as severe anemia or hypocalcaemia - history of anaphylaxis to a medication, diet, or environmental exposure such as bee sting - previous diagnosis of chronic fatigue syndrome, fibromyalgia, lupus, sjogren's syndrome, or postural orthostatic tachycardia syndrome (pots) - previous diagnosis of sleep apnea - participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from baseline - the presence of a clinically significant infection in the judgement of the investigator, within seven days of baseline - positive test for hepatitis b, c, or hiv at screening - positive pregnancy test at screening or baseline - female subjects currently pregnant or breast feeding at baseline - inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the investigator, would make the subject unsuitable for study participation

- previous admission to the intensive care unit for covid-19-related symptoms - presence of orthostatic hypotension or tachycardia at screening - completion of covid-19 vaccination less than 4 weeks of baseline (i.e., 4 weeks after the second dose of a two-dose vaccine or 4 weeks after a single dose vaccine) - use of therapies to treat covid-19 symptoms such as remdesivir, dexamethasone (or any other corticosteroid), or convalescent plasma within 14 days of baseline - use of concomitant medications that are sedating - screening lab abnormalities that may cause fatigue such as severe anemia or hypocalcaemia - history of anaphylaxis to a medication, diet, or environmental exposure such as bee sting - previous diagnosis of chronic fatigue syndrome, fibromyalgia, lupus, sjogren's syndrome, or postural orthostatic tachycardia syndrome (pots) - previous diagnosis of sleep apnea - participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from baseline - the presence of a clinically significant infection in the judgement of the investigator, within seven days of baseline - positive test for hepatitis b, c, or hiv at screening - positive pregnancy test at screening or baseline - female subjects currently pregnant or breast feeding at baseline - inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the investigator, would make the subject unsuitable for study participation

July 1, 2021, 2:30 a.m. usa

- previous admission to the intensive care unit for covid-19-related symptoms - presence of orthostatic hypotension or tachycardia at screening - completion of covid-19 vaccination less than 4 weeks of baseline (i.e., 4 weeks after the second dose of a two-dose vaccine or 4 weeks after a single dose vaccine) - use of therapies to treat covid-19 symptoms such as remdesivir, dexamethasone (or any other corticosteroid), or convalescent plasma within 14 days of baseline - previous diagnosis of chronic fatigue syndrome, fibromyalgia, lupus, sjogren's syndrome, or postural orthostatic tachycardia syndrome (pots) - the use of a continuous positive airway pressure (cpap) device for the treatment of sleep apnea - participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from baseline - the presence of a clinically significant infection in the judgement of the investigator, within seven days of baseline - positive test for hepatitis b, c, or hiv at screening - positive pregnancy test at screening or baseline - female subjects currently pregnant or breast feeding at baseline - inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the investigator, would make the subject unsuitable for study participation

- previous admission to the intensive care unit for covid-19-related symptoms - presence of orthostatic hypotension or tachycardia at screening - completion of covid-19 vaccination less than 4 weeks of baseline (i.e., 4 weeks after the second dose of a two-dose vaccine or 4 weeks after a single dose vaccine) - use of therapies to treat covid-19 symptoms such as remdesivir, dexamethasone (or any other corticosteroid), or convalescent plasma within 14 days of baseline - previous diagnosis of chronic fatigue syndrome, fibromyalgia, lupus, sjogren's syndrome, or postural orthostatic tachycardia syndrome (pots) - the use of a continuous positive airway pressure (cpap) device for the treatment of sleep apnea - participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from baseline - the presence of a clinically significant infection in the judgement of the investigator, within seven days of baseline - positive test for hepatitis b, c, or hiv at screening - positive pregnancy test at screening or baseline - female subjects currently pregnant or breast feeding at baseline - inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the investigator, would make the subject unsuitable for study participation