COVID-10 infection
Conditions
Brief summary
Number and proportion of participants who develop severe COVID-19 following kidney transplantation up to 28 days and 90 days post-transplant. Severe SARS-CoV-2 will be defined as: Hypoxemia (O2 sat <94%), one or more compatible respiratory symptoms (fever, dyspnea, increased respiratory frequency > 22, cough) AND new radiologic infiltrates compatible with COVID-19 in a chest X Ray, chest CT or ultrasound.
Detailed description
Number of deaths at days 28 and 90 post-transplantation (global and attributable to COVID-19), -Time (days) to resolution of all targeted symptoms through Day 28 and Day 90 -Time (days) to alleviation of symptoms through Day 28 and Day 90. -Duration of targeted COVID-19 symptoms. -Proportion of participants requiring extension of the hospitalization beyond POD10. -Number of days in hospital and intensive care unit (ICU) stay -Proportion of participants with symptomatic rebound through day 28. IMV through day 28., - Number and proportion of participants with negative nasopharyngeal SARS-CoV-2 PCR, and median CT values if positive, at POD 0 (time of diagnosis), POD5, POD10, POD14, POD21, and POD28. - Whole genome sequencing of SARS-CoV-2 to evaluate emergence of substitutions associated with resistance to remdesivir in participants who have a positive SARS-CoV-2 PCR and CT values below or equal to 25., - Number and % of participants with stage 2 or 3 AKI through day 28, or RRTdependence at day 28 and 90. -Number and proportion of patients that present a proven-biopsy showing acute humoral or cellular rejection at D28 and D90 posttransplant. -Difference in the number, proportion, and days of dialysis per patient needed at D7, D28 and D90 compared to a local historical cohort of kidney transplants performed between 2023 and 2024., Incidence of SAEs and AEs leading to drug discontinuation.- Number and proportion of any treatment-emergent hepatic AE (Elevation of any grade in ALT or AST levels, prothrombin time or INR, or blood bilirubin), number and proportion of severe liver failures. - Number of patients that develop hypersensitivity or infusion-related reactions
Interventions
Sponsors
Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and proportion of participants who develop severe COVID-19 following kidney transplantation up to 28 days and 90 days post-transplant. Severe SARS-CoV-2 will be defined as: Hypoxemia (O2 sat <94%), one or more compatible respiratory symptoms (fever, dyspnea, increased respiratory frequency > 22, cough) AND new radiologic infiltrates compatible with COVID-19 in a chest X Ray, chest CT or ultrasound. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of deaths at days 28 and 90 post-transplantation (global and attributable to COVID-19), -Time (days) to resolution of all targeted symptoms through Day 28 and Day 90 -Time (days) to alleviation of symptoms through Day 28 and Day 90. -Duration of targeted COVID-19 symptoms. -Proportion of participants requiring extension of the hospitalization beyond POD10. -Number of days in hospital and intensive care unit (ICU) stay -Proportion of participants with symptomatic rebound through day 28. IMV through day 28., - Number and proportion of participants with negative nasopharyngeal SARS-CoV-2 PCR, and median CT values if positive, at POD 0 (time of diagnosis), POD5, POD10, POD14, POD21, and POD28. - Whole genome sequencing of SARS-CoV-2 to evaluate emergence of substitutions associated with resistance to remdesivir in participants who have a positive SARS-CoV-2 PCR and CT values below or equal to 25., - Number and % of participants with stage 2 or 3 AKI through day 28, or RRTdependence | — |
Countries
Spain
Outcome results
None listed