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Tests treatment safety and results for COVID - 19
Official title Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients
ClinicalTrials.gov ID: NCT07197164
What this study is testing
What is Remdesivir (RDV)?
Remdesivir (RDV) is an investigational medicine, given as an once-daily, being studied as a potential treatment for covid - 19.
Also referred to as Veklury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Since the start of the COVID-19 pandemic, the approach to solid organ transplantation has evolved. Transplants using organs (excluding lungs) from COVID-19-positive donors have shown short-term safety, but there is limited data on recipients who are SARS-CoV-2 positive.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Pregnant or breastfeeding women, at time of enrollment
- Patients requiring supplementary oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis.
- 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)...
- 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
See the full eligibility 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 (+/-)...
- 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...
- 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...
- Having understood the information provided and capable of giving consent to participate in this trial by signing the Informed Consent document.
- Pregnant or breastfeeding women, at time of enrollment
- Patients requiring supplementary oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis.
- 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...
- 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)
- 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...
- Suspected or confirmed concurrent active respiratory infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Badalona, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Badalona, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.