Official Title
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
Brief Summary

Since the start of the COVID-19 pandemic, the approach to solid organ transplantation hasevolved. Transplants using organs (excluding lungs) from COVID-19-positive donors haveshown short-term safety, but there is limited data on recipients who are SARS-CoV-2positive. Currently, kidney transplants in such recipients are delayed until symptomsresolve and a negative PCR is preferred, despite the risks of prolonged dialysis andincreased cold ischemia time.Recent data from the Omicron era suggest that early antiviral treatment may reducecomplications. Immunosuppressive therapy might even help mitigate severe inflammatoryresponses. The proposed study aims to show that kidney transplantation can be safelyperformed in asymptomatic or mildly symptomatic COVID-19-positive recipients who beginantiviral treatment (remdesivir) within 24 hours before transplant and continue for 10days. This could reduce waiting times and improve outcomes.Remdesivir is an antiviral safe for use in patients with low kidney function, includingthose on dialysis or post-transplant, with minimal side effects. The hypothesis is thatthis treatment strategy can prevent progression to severe COVID-19 and allow safetransplantation

Detailed Description

Not Provided

Recruiting
COVID - 19
Renal Transplant
SARS CoV 2 Infection

Drug: Remdesivir (RDV)

Participants will receive their first dose of remdesivir also within the 24 (+/-12) hours
prior to going to the operating room. Remdesivir doses will be 200 mg on day 1, followed
by 100 mg daily from days 2 to 10, for a total of 10 days.
Other Name: Veklury

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

Hospital Universitari Germans Trias i Pujol
Badalona 3129028, Barcelona, Spain

Investigator: Alba Romero Caballero, MD, MSc
Contact: +34 93 465 78 97
assaig@scienhub.org

Contacts

Alba Romero Caballero, MD, MSc
+34 93 465 78 97
assaig@scienhub.org

Cristina Herrero Sánchez
info@scienhub.org

Not Provided

Gilead Sciences
NCT Number
MeSH Terms
COVID-19
Remdesivir