Safety and Effectiveness of a 10-Day Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients with Mild or No Symptoms: A Single-Group Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

7 Aug 2025 → ongoing

Decision date (initial)

2025-06-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Gilead and Sponsor Resorces

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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.

Secondary objectives 5

1. To describe 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
2. To describe the duration and the severity of COVID-19 symptoms in kidney transplant recipients a peri-transplant 10-day course of remdesivir.
3. To describe the clearance kinetics of SARS-CoV-2 infection in the post-transplant period in asymptomatic or paucisymptomatic SARS-Cov-2-positive kidney transplant recipients receiving a 10-day course of remdesivir.To evaluate the emergence of viral resistances to remdesivir.
4. To describe the incidence of graft complications (delayed graft function, acute rejection and graft loss at 28 and 90 days) in asymptomatic or paucisymptomatic SARS-CoV-2-positive kidney transplant recipients receiving a 10-day course of remdesivir.
5. To evaluate the safety profile of remdesivir in asymptomatic or paucisymptomatic SARS-Cov-2-positive kidney transplant recipients receiving a 10-day course of remdesivir.

Conditions and MedDRA coding

COVID-10 infection

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. At least 18 years-old
2. 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.
3. Have a positive SARS-CoV-2 nasopharyngeal PCR or RAT within 5 days prior to transplant surgery.
4. Have previously received at least three SARS-CoV-2 vaccine doses, with a minimum time elapsed of 3 months since the last dose received.
5. 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.
6. Having understood the information provided and capable of giving consent to participate in this trial by signing the Informed Consent document.
7. 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 13

1. Patients requiring supplementary oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis
2. 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.
3. Prior participation in this trial.
4. 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.
5. 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.
6. Patients having fever (>38ºC) in the last 48 hours or shortness of breath in the previous 5 days.
7. Previous history of hypersensitivity, documented allergy or contraindications to receive remdesivir.
8. ABO incompatible kidney transplant
9. Desensitization therapy indicated as induction therapy for high immunological risk transplant with Donor Specific HLA Antibodies (DSA)
10. Participants who receive different types of induction immunosuppression other than the standard induction protocols with lymphocyte- depleting agents (thymoglobulin or basiliximab).
11. 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
12. Suspected or confirmed concurrent active respiratory infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
13. Pregnant or breastfeeding women, at time of enrollment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 5

1. Number of deaths at days 28 and 90 post-transplantation (global and attributable to COVID-19)
2. -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.
3. - 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.
4. - 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.
5. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Carretera Canyet S/n

City

Badalona

Postcode

08916

Country

Spain

Scientific contact point

Organisation

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

Contact name

Alba Romero

Public contact point

Organisation

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

Contact name

Alba Romero

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications