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Recruiting NCT04494776

NCT04494776 SARS-COV-2 Infection in Kidney Transplant Recipients: a Brazilian Multicenter Study

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Clinical Trial Summary
NCT ID NCT04494776
Status Recruiting
Phase —
Sponsor Helio Tedesco Silva Junior
Condition SARS-CoV-2 Infection
Study Type OBSERVATIONAL
Enrollment 500 participants
Start Date 2020-05-21
Primary Completion 2022-12-03

Eligibility & Interventions

Sex All sexes
Min Age N/A
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 500 participants in total. It began in 2020-05-21 with a primary completion date of 2022-12-03.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

COVID-19 is the pandemic disease caused by the SARS-CoV-2 coronavirus. It is a highly contagious viral disease, the condition of which main clinical symptoms are characterized by fever and respiratory symptoms. Evidence indicates to worse outcomes in patients with pre-existing diseases, such as diabetes, arterial hypertension, heart disease, pneumopathies, chronic kidney disease, and immunodeficiencies. Recipients of kidney transplants make prolonged use of immunosuppressive drugs to inhibit the acquired immune response, notably the activity of lymphocytes. Due to this potential to modulate the immune and inflammatory response, it is speculated that the clinical and laboratory condition of COVID-19 in these patients is atypical. Preliminary evidence suggests worse outcomes of COVID-19 in immunosuppressed patients, as carriers of cancer. However, information on kidney transplant recipients is insufficient. So far, only reports of the case are available in the literature with different clinical presentations and outcomes. The aim of this study is, therefore, to characterize the demographics, clinical and laboratory conditions, and the outcomes of COVID-19 in kidney transplant recipients in a national multicenter cohort.

Eligibility Criteria

Inclusion Criteria: 1. Kidney transplant recipients, which may be multi-organ recipients, transplanted in any follow-up period; 2. Positive diagnostic test for COVID-19 (detection of viral load, test for detection of antigens or tests for detection of antibodies); 3. Outpatient or hospital management; 4. Adults and children. Exclusion Criteria: \-

Contact & Investigator

Central Contact

Helio Tedesco

✉ heliotedesco@medfarm.com.br

📞 +55 11 5087-8113

Principal Investigator

Jose Osmar Medina

STUDY DIRECTOR

Hospital do Rim

Frequently Asked Questions

Who can join the NCT04494776 clinical trial?

This trial is open to participants of all sexes, studying SARS-CoV-2 Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04494776 currently recruiting?

Yes, NCT04494776 is actively recruiting participants. Contact the research team at heliotedesco@medfarm.com.br for enrollment information.

Where is the NCT04494776 trial being conducted?

This trial is being conducted at São Paulo, Brazil.

Who is sponsoring the NCT04494776 clinical trial?

NCT04494776 is sponsored by Helio Tedesco Silva Junior. The principal investigator is Jose Osmar Medina at Hospital do Rim. The trial plans to enroll 500 participants.

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