Created at Source Raw Value Validated value
May 12, 2022, 1:30 a.m. oms

To evaluate the early efficacy of CYP-001 in adults with respiratory failure being treated in intensive care units (ICU); based on improvements in P/F ratio compared to controls. This outcome is defined as a trend in trajectory of P/F ratio between groups by day 7. P/F ratio is collected from ventilatory support data combined with arterial blood gas measures[By day 7 in the study (within days 1-7). P/F ratio will be collected as per routine standard collection of data to inform respiratory function (at least 4 hourly when relevant) plus every 15 minutes during cell adminstration and 1; 2; 3; 4 and 5 hours after];To assess the safety and tolerability of CYP-001 in adults with respiratory failure being treated in ICU measured by the incidence and severity of treatment-emergent adverse events (including events related with reactions to cryoprotectant; fever read from digital thermometer; allergy; olfactory/taste disturbances); safety laboratory evaluations (immunology screen with full blood examination) and vital signs (including significant fluctuations from clinically acceptable BP; and HR and SaO2 levels measured via pulse oximetry)[Up to day 28 in the study. On days 0-7 this will be collected routinely in standard care (at least 4-hourly) plus every 15 minutes during cell administration and 1; 2; 3; 4 and 5 hours after; then daily after day 8]

To evaluate the early efficacy of CYP-001 in adults with respiratory failure being treated in intensive care units (ICU); based on improvements in P/F ratio compared to controls. This outcome is defined as a trend in trajectory of P/F ratio between groups by day 7. P/F ratio is collected from ventilatory support data combined with arterial blood gas measures[By day 7 in the study (within days 1-7). P/F ratio will be collected as per routine standard collection of data to inform respiratory function (at least 4 hourly when relevant) plus every 15 minutes during cell adminstration and 1; 2; 3; 4 and 5 hours after];To assess the safety and tolerability of CYP-001 in adults with respiratory failure being treated in ICU measured by the incidence and severity of treatment-emergent adverse events (including events related with reactions to cryoprotectant; fever read from digital thermometer; allergy; olfactory/taste disturbances); safety laboratory evaluations (immunology screen with full blood examination) and vital signs (including significant fluctuations from clinically acceptable BP; and HR and SaO2 levels measured via pulse oximetry)[Up to day 28 in the study. On days 0-7 this will be collected routinely in standard care (at least 4-hourly) plus every 15 minutes during cell administration and 1; 2; 3; 4 and 5 hours after; then daily after day 8]

Jan. 8, 2021, 12:45 a.m. oms

To evaluate the early efficacy of CYP-001 in adults with COVID-19 being treated in intensive care units (ICU); based on improvements in P/F ratio compared to controls. This outcome is defined as a trend in trajectory of P/F ratio between groups by day 7. P/F ratio is collected from ventilatory support data combined with arterial blood gas measures[By day 7 in the study (within days 1-7). P/F ratio will be collected as per routine standard collection of data to inform respiratory function (at least 4 hourly when relevant) plus every 15 minutes during cell adminstration and 1; 2; 3; 4 and 5 hours after];To assess the safety and tolerability of CYP-001 in adults with COVID-19 being treated in ICU measured by the incidence and severity of treatment-emergent adverse events (including events related with reactions to cryoprotectant; fever read from digital thermometer; allergy; olfactory/taste disturbances); safety laboratory evaluations (immunology screen with full blood examination) and vital signs (including significant fluctuations from clinically acceptable BP; and HR and SaO2 levels measured via pulse oximetry)[Up to day 28 in the study. On days 0-7 this will be collected routinely in standard care (at least 4-hourly) plus every 15 minutes during cell administration and 1; 2; 3; 4 and 5 hours after; then daily after day 8]

To evaluate the early efficacy of CYP-001 in adults with COVID-19 being treated in intensive care units (ICU); based on improvements in P/F ratio compared to controls. This outcome is defined as a trend in trajectory of P/F ratio between groups by day 7. P/F ratio is collected from ventilatory support data combined with arterial blood gas measures[By day 7 in the study (within days 1-7). P/F ratio will be collected as per routine standard collection of data to inform respiratory function (at least 4 hourly when relevant) plus every 15 minutes during cell adminstration and 1; 2; 3; 4 and 5 hours after];To assess the safety and tolerability of CYP-001 in adults with COVID-19 being treated in ICU measured by the incidence and severity of treatment-emergent adverse events (including events related with reactions to cryoprotectant; fever read from digital thermometer; allergy; olfactory/taste disturbances); safety laboratory evaluations (immunology screen with full blood examination) and vital signs (including significant fluctuations from clinically acceptable BP; and HR and SaO2 levels measured via pulse oximetry)[Up to day 28 in the study. On days 0-7 this will be collected routinely in standard care (at least 4-hourly) plus every 15 minutes during cell administration and 1; 2; 3; 4 and 5 hours after; then daily after day 8]

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

To evaluate the early efficacy of CYP-001 in adults with COVID-19 being treated in intensive care units (ICU); based on improvements in P/F ratio compared to controls. This outcome is defined as a proportion of participants showing a 50% improvement in P/F ratio by day 7. P/F ratio is collected from ventilatory support data combined with arterial blood gas measures[By day 7 after enrolment in the study (within days 1-7). P/F ratio will be collected as per routine standard collection of data to inform respiratory function (at least 4 hourly when relevant) plus every 15 minutes during cell adminstration and 1; 2; 3; 4 and 5 hours after];To assess the safety and tolerability of CYP-001 in adults with COVID-19 being treated in ICU measured by the incidence and severity of treatment-emergent adverse events (including events related with reactions to cryoprotectant; fever read from digital thermometer; allergy; olfactory/taste disturbances); safety laboratory evaluations (immunology screen with full blood examination) and vital signs (including significant fluctuations from clinically acceptable BP; and HR and SaO2 levels measured via pulse oximetry)[Up to day 28 after enrolment in the study. On days 0-7 this will be collected routinely in standard care (at least 4-hourly) plus every 15 minutes during cell administration and 1; 2; 3; 4 and 5 hours after; then daily after day 8]

To evaluate the early efficacy of CYP-001 in adults with COVID-19 being treated in intensive care units (ICU); based on improvements in P/F ratio compared to controls. This outcome is defined as a proportion of participants showing a 50% improvement in P/F ratio by day 7. P/F ratio is collected from ventilatory support data combined with arterial blood gas measures[By day 7 after enrolment in the study (within days 1-7). P/F ratio will be collected as per routine standard collection of data to inform respiratory function (at least 4 hourly when relevant) plus every 15 minutes during cell adminstration and 1; 2; 3; 4 and 5 hours after];To assess the safety and tolerability of CYP-001 in adults with COVID-19 being treated in ICU measured by the incidence and severity of treatment-emergent adverse events (including events related with reactions to cryoprotectant; fever read from digital thermometer; allergy; olfactory/taste disturbances); safety laboratory evaluations (immunology screen with full blood examination) and vital signs (including significant fluctuations from clinically acceptable BP; and HR and SaO2 levels measured via pulse oximetry)[Up to day 28 after enrolment in the study. On days 0-7 this will be collected routinely in standard care (at least 4-hourly) plus every 15 minutes during cell administration and 1; 2; 3; 4 and 5 hours after; then daily after day 8]