Remdesivir for COVID-19

Inclusion criteria

• {"criterion_text":"-At least 18 years-old"}
• {"criterion_text":"-Patients with end-stage kidney disease that are included on the local kidney transplant waiting list who get an offer of a compatible organ and, subsequently, have a transplant procedure scheduled in the next 24 (+/-) 12 hours, or patients with end-stage kidney disease that are planned to receive a non-cadaveric donor kidney transplant on the following 5 days."}
• {"criterion_text":"-Have a positive SARS-CoV-2 nasopharyngeal PCR or RAT within 5 days prior to transplant surgery."}
• {"criterion_text":"-Have previously received at least three SARS-CoV-2 vaccine doses, with a minimum time elapsed of 3 months since the last dose received."}
• {"criterion_text":"-Are asymptomatic or have mild acute COVID-19 symptoms during the previous 5 days (headache, sore throat, cough, chest pain, nausea, diarrhea, fatigue, loss of smell or taste, myalgia) excluding fever in the previous 48 hours (>38ºC) or shortness of breath."}
• {"criterion_text":"-Having understood the information provided and capable of giving consent to participate in this trial by signing the Informed Consent document."}
• {"criterion_text":"-Post-menopausal or fertile females (females who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) that agree to avoid pregnancy during the study. If sexually active female; using highly effective contraceptive methods (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner*) while on study treatment. All female volunteers must be willing to undergo urine pregnancy tests at time of enrollment"}

Exclusion criteria

• {"criterion_text":"-Patients requiring supplementary oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis"}
• {"criterion_text":"-Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator."}
• {"criterion_text":"-Prior participation in this trial."}
• {"criterion_text":"-Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members."}
• {"criterion_text":"-Patients having any of the following at the screening period: i) O2 saturation below 94% on room air; ii) respiratory frequency of > 30bpm; or iii) Xray showing new-onset pulmonary infiltrates suggesting COVID-19 pneumonia."}
• {"criterion_text":"-Patients having fever (>38ºC) in the last 48 hours or shortness of breath in the previous 5 days."}
• {"criterion_text":"-Previous history of hypersensitivity, documented allergy or contraindications to receive remdesivir."}
• {"criterion_text":"-ABO incompatible kidney transplant"}
• {"criterion_text":"-Desensitization therapy indicated as induction therapy for high immunological risk transplant with Donor Specific HLA Antibodies (DSA)"}
• {"criterion_text":"-Participants who receive different types of induction immunosuppression other than the standard induction protocols with lymphocyte- depleting agents (thymoglobulin or basiliximab)."}
• {"criterion_text":"-Active liver disease with AST or ALT >3 ULN, Total bilirubin ≥2 × ULN (for Gilbert’s syndrome, direct bilirubin >ULN is exclusionary) within the past 3 months, or liver function impairment with Class B or C per Child Pugh classification"}
• {"criterion_text":"-Suspected or confirmed concurrent active respiratory infection other than COVID-19 that may interfere with the evaluation of response to the study intervention."}
• {"criterion_text":"-Pregnant or breastfeeding women, at time of enrollment"}

Primary endpoints

• {"endpoint_text":"-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.","definition_or_measurement_approach":"Measure number and proportion of participants meeting the definition of severe SARS-CoV-2 within 28 and 90 days post-transplant; severe defined by hypoxemia (O2 sat <94%), ≥1 compatible respiratory symptom (fever, dyspnea, increased respiratory frequency >22, cough) AND new radiologic infiltrates on chest X-ray, CT or ultrasound."}

Secondary endpoints

• {"endpoint_text":"-Number of deaths at days 28 and 90 post-transplantation (global and attributable to COVID-19)","definition_or_measurement_approach":"Count deaths at days 28 and 90 post-transplantation; report overall and those attributable to COVID-19."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Time-to-event measures for symptom resolution and alleviation through Day 28 and Day 90; durations of symptoms; proportions requiring extended hospitalization beyond POD10; number of hospital and ICU days; proportion with symptomatic rebound through Day 28; incidence of invasive mechanical ventilation through Day 28."}
• {"endpoint_text":"-\tNumber 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. -\tWhole 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.","definition_or_measurement_approach":"Serial nasopharyngeal SARS-CoV-2 PCR at specified post-operative days with PCR negativity counts and median Ct values; perform whole genome sequencing for participants with positive PCR and Ct ≤25 to assess emergence of resistance-associated substitutions."}
• {"endpoint_text":"-\tNumber 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.","definition_or_measurement_approach":"Assess acute kidney injury stages and renal replacement therapy dependence through Day 28 and Day 90; record biopsy-proven acute rejection at D28 and D90; compare dialysis metrics at D7, D28, D90 to a local historical cohort."}
• {"endpoint_text":"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","definition_or_measurement_approach":"Record incidence of SAEs and AEs leading to discontinuation; capture treatment-emergent hepatic AEs (ALT/AST, PT/INR, bilirubin), severe liver failures, and hypersensitivity/infusion-related reactions."}

Spain

Earliest CTIS Part Ii Submission Date

12-06-2025

Latest Decision Or Authorization Date

30-06-2025

Processing Time Days

18

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain

Third parties

• {"country":"Ireland","full_name":"Gilead Sciences Ireland Unlimited Company","duties_or_roles":"Source of monetary support and supplier of investigational product (Veklury/remdesivir)","organisation_type":"Pharmaceutical company"}