Remdesivir to prevent severe COVID-19 in kidney transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Alba Romero Caballero, MD, MSc
• Email: assaig@scienhub.org
• Phone: +34 93 465 78 97

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.