2024-519272-96-00Not yet recruitingPhase 2
SAFETY AND EFFICACY OF A 10-DAY COURSE OF REMDESIVIR TO PREVENT SEVERE COVID-19 IN ASYMPTOMATIC OR PAUCISYMPTOMATIC SARS-COV-2-POSITIVE KIDNEY TRANSPLANT RECIPIENTS: A SINGLE-ARM PROOF-OF-CONCEPT INTERVENTIONAL TRIAL
Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C1 site in 1 country15 target enrollmentStarted: June 30, 2025Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
To evaluate the clinical efficacy of administering antiviral treatment with IV remdesivir for 10 days in asymptomatic or paucisymptomatic kidney transplant recipients who are SARS-CoV-2-positive by nasopharyngeal PCR or RAT in the 5 days before the date of transplant.
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Overall Period
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years-old
- •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.
- •Have a positive SARS-CoV-2 nasopharyngeal PCR or RAT within 5 days prior to transplant surgery.
- •Have previously received at least three SARS-CoV-2 vaccine doses, with a minimum time elapsed of 3 months since the last dose received.
- •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.
- •Having understood the information provided and capable of giving consent to participate in this trial by signing the Informed Consent document.
- •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
- •Patients requiring supplementary oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis
- •Participants who receive different types of induction immunosuppression other than the standard induction protocols with lymphocyte- depleting agents (thymoglobulin or basiliximab).
- •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
- •Suspected or confirmed concurrent active respiratory infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
- •Pregnant or breastfeeding women, at time of enrollment
- •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.
- •Prior participation in this trial.
- •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.
- •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.
- •Patients having fever (>38ºC) in the last 48 hours or shortness of breath in the previous 5 days.
- •Previous history of hypersensitivity, documented allergy or contraindications to receive remdesivir.
- •ABO incompatible kidney transplant
- •Desensitization therapy indicated as induction therapy for high immunological risk transplant with Donor Specific HLA Antibodies (DSA)
Outcomes
Primary Outcomes
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.
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 Outcomes
- 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
Investigators
Alba Romero
Scientific
Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C
Study Sites (1)
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