Created at Source Raw Value Validated value
July 30, 2021, 1:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "The researchers aim to conduct a pilot prospective design of 6 to 12 months duration regarding the use of therapeutic plasma exchange (TPE) in serious COVID-19. The study will be multicenter. Adult ICU patients with serious/life-threatening COVID-19 receiving standard empiric therapies as per institutional and international protocols such as available antiviral treatments; hydroxychloroquine; mechanical (ARDS-net and prone position) ventilation; fluid resuscitation; vasoactive substances; antibiotics amongst other usual ICU supportive therapies will be randomised to control or TPE groups. Those in the control group will receive usual care. Those in the TPE group will receive usual care plus TPE therapy. Randomization of the aforementioned groups will be done as follows. Eligible consented patients will be randomized after their stratification by ICU center and two PaO2/FIO2 ratio categories (>150 and <=150). Randomization will occur in variable block sizes of 4 to 8 patients. The researchers will utilize a web-based randomization service (randomize.net) to allocate patients to their respective strata prior to the intervention or control therapy. Given the nature of the TPE technology; the intervention will be unblinded (open label); hence; no enrollment concealment will be expedited. However; the lack of allocation concealment will be mitigated as much as possible by the following measures. First; the primary outcome of mortality will not be disputable. Second; the researchers have standardized co-interventions that impact on mortality as much as possible. These interventions include: 1. Concomitant drug therapies for COVID-19 2. Algor", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 1000, "treatment_name": "Plasma exchange", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]

July 23, 2021, 11 p.m. oms

[]

Oct. 26, 2020, 8:29 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "The researchers aim to conduct a pilot prospective design of 6 to 12 months duration regarding the use of therapeutic plasma exchange (TPE) in serious COVID-19. The study will be multicenter. Adult ICU patients with serious/life-threatening COVID-19 receiving standard empiric therapies as per institutional and international protocols such as available antiviral treatments; hydroxychloroquine; mechanical (ARDS-net and prone position) ventilation; fluid resuscitation; vasoactive substances; antibiotics amongst other usual ICU supportive therapies will be randomised to control or TPE groups. Those in the control group will receive usual care. Those in the TPE group will receive usual care plus TPE therapy. Randomization of the aforementioned groups will be done as follows. Eligible consented patients will be randomized after their stratification by ICU center and two PaO2/FIO2 ratio categories (>150 and <=150). Randomization will occur in variable block sizes of 4 to 8 patients. The researchers will utilize a web-based randomization service (randomize.net) to allocate patients to their respective strata prior to the intervention or control therapy. Given the nature of the TPE technology; the intervention will be unblinded (open label); hence; no enrollment concealment will be expedited. However; the lack of allocation concealment will be mitigated as much as possible by the following measures. First; the primary outcome of mortality will not be disputable. Second; the researchers have standardized co-interventions that impact on mortality as much as possible. These interventions include: 1. Concomitant drug therapies for COVID-19 2. Algor", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]