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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519272-96-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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Since the start of the COVID-19 pandemic, the approach to solid organ transplantation has evolved. Transplants using organs (excluding lungs) from COVID-19-positive donors have shown short-term safety, but there is limited data on recipients who are SARS-CoV-2 positive. Currently, kidney transplants in such recipients are delayed until symptoms resolve and a negative PCR is preferred, despite the risks of prolonged dialysis and increased cold ischemia time.
Recent data from the Omicron era suggest that early antiviral treatment may reduce complications. Immunosuppressive therapy might even help mitigate severe inflammatory responses. The proposed study aims to show that kidney transplantation can be safely performed in asymptomatic or mildly symptomatic COVID-19-positive recipients who begin antiviral treatment (remdesivir) within 24 hours before transplant and continue for 10 days. This could reduce waiting times and improve outcomes.
Remdesivir is an antiviral safe for use in patients with low kidney function, including those on dialysis or post-transplant, with minimal side effects. The hypothesis is that this treatment strategy can prevent progression to severe COVID-19 and allow safe transplantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Single Arm with remdesivir |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir (RDV) | Drug | Participants will receive their first dose of remdesivir also within the 24 (+/-12) hours prior to going to the operating room. Remdesivir doses will be 200 mg on day 1, followed by 100 mg daily from days 2 to 10, for a total of 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of participants who develop severe COVID-19 following kidney transplantation | Primary estimates: 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. | to 28 days and 90 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of deaths (all causes mortality) at days 28 and 90 post-transplant | the cumulative mortality at days 28 and 90 after transplant in asymptomatic or paucisymptomatic SARS-CoV-2-positive kidney transplant recipients receiving a 10-day course of remdesivir | at days 28 and 90 after transplant |
| Time (days) to resolution and to recovery of all targeted symptoms through Day 28 and Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alba Romero Caballero, MD, MSc | Contact | +34 93 465 78 97 | assaig@scienhub.org | |
| Cristina Herrero Sánchez | Contact | info@scienhub.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Recruiting | Badalona | Barcelona | 08916 | Spain |
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Phase 2, proof of concept open-label, single-center, single- arm clinical trial
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|
Duration of targeted COVID-19 symptoms (COVID-19 Questionnaire). |
| At day 28 and day 90 |
| Proportion of participants requiring extension of the hospitalization beyond POD10 (all cause and related to COVID-19) | % participants with COVID complications at the hospitalization that requires invasive Mechanical ventilation, intensive care unit (ICU) stayed or extension of the hospitalization related to COVID-19 | At day 28 |
| Proportion of participants with symptomatic rebound through day 28. | % participant who, after an initial improvement or resolution of symptoms, experience a recurrence of symptoms within the 28-day follow-up period | At day 28 |
| To describe the clearance kinetics of SARS-CoV-2 infection in the post-transplant period | 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 and 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. | At day 0, 5, 10, 14, 21 and 28 |
| Number of Participants with Treatment-Related Adverse Events | Incidence of SAEs and AEs leading to drug discontinuation and 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 (defined as elevated LFTs and presence of coagulopathy or hepatic encephalopathy) and mumber of patients that develop hypersensitivity or infusion-related reactions | From enrollment to the end of study at 6 months |
| incidence of graft complications | Number and proportion of participants with stage 2 or 3 AKI and or that present a proven-biopsy showing acute humoral or cellular rejection and or dialysis needed | at day 7, day 28 and day 90 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000606551 | remdesivir |
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