Remdesivir to prevent severe COVID-19 in kidney transplant patients

Safety and Efficacy of 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

This study will try giving remdesivir around the time of transplant to see if it prevents severe COVID-19 in adults receiving a kidney transplant who are currently SARS‑CoV‑2 positive with no or mild symptoms.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia (Academic / other)
• Drugs / interventions: basiliximab
• Locations: 1 site (Badalona, Barcelona)
• Trial ID: NCT07197164 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study gives remdesivir beginning within 24 hours before kidney transplantation and continues treatment for 10 days to recipients who test positive for SARS‑CoV‑2 but have asymptomatic or mild disease. Eligible adults are on the local transplant waiting list (or scheduled to receive a living donor kidney) and have a positive PCR or rapid antigen test within five days before surgery and at least three prior COVID‑19 vaccine doses. The primary focus is safety and whether peritransplant antiviral therapy reduces progression to severe COVID‑19 and allows timely transplantation without added complications. The trial is led at Hospital Universitari Germans Trias i Pujol in Badalona, Spain with industry collaboration for the antiviral supply.

Who should consider this trial

Good fit: Adults (≥18) with end‑stage kidney disease who are on the local transplant list or scheduled for a living donor kidney transplant within the allowed time window, have a positive SARS‑CoV‑2 PCR or antigen test within five days, are asymptomatic or have only mild symptoms, and have received at least three COVID‑19 vaccine doses are ideal candidates.

Not a fit: Patients with moderate or severe COVID‑19 (for example recent fever >38°C or shortness of breath), those who do not meet the vaccination or timing criteria, or those with contraindications to remdesivir are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could allow SARS‑CoV‑2–positive kidney recipients to receive transplants sooner and reduce risks from prolonged dialysis and increased cold ischemia time while lowering the chance of severe post‑transplant COVID‑19.

How similar studies have performed: Early antiviral treatment in the Omicron era has been associated with reduced complications in high‑risk patients, but the specific use of peritransplant remdesivir in SARS‑CoV‑2–positive kidney recipients is a relatively new approach with limited direct evidence.

Eligibility criteria

Inclusion Criteria:

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. 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 fe-male; 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.
7. Having understood the information provided and capable of giving consent to participate in this trial by signing the Informed Consent document.

Exclusion Criteria:

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

Where this trial is running

Badalona, Barcelona

• Hospital Universitari Germans Trias i Pujol — Badalona, Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: Alba Romero Caballero, MD, MSc

Conditions COVID - 19; Renal Transplant; SARS CoV 2 Infection