Status:
UNKNOWN
Evaluate the Impact, Safety, Tolerability and Immunogenicity of the Coronavac Vaccine in Kidney Transplant Recipients
Lead Sponsor:
Hospital do Rim e Hipertensão
Conditions:
SARS-CoV Infection
Coronavirus Infection
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
Since the beginning of the SARS-CoV-2 pandemic, 1031 (8.7%) of the 11875 kidney transplant recipients being followed up at Hospital do Rim have been infected. The overall lethality rate was 24%, reach...
Eligibility Criteria
Inclusion
- Adults over 18 years old;
- Time after transplantation greater than 3 months;
- Time after treatment with anti-thymocyte globulin longer than 4 weeks;
- Able and willing (in the investigator's opinion) to comply with all study requirements;
- Provide written informed consent
Exclusion
- Planned receipt of any vaccine (authorized or experimental), within 30 days before and after vaccination;
- Prior receipt of an experimental or authorized vaccine with the possibility of impacting the interpretation of the study data (for example, vectorized vaccines by Adenovirus, any vaccines against coronavirus);
- Administration of immunoglobulins and / or any blood products in the three months prior to the planned administration of the candidate vaccine;
- Any history of angioedema or anaphylaxis;
- Pregnancy, lactation or willingness / intention to become pregnant during the study;
- Diagnosis or current treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ);
- History of severe psychiatric illness that possibly affects your participation in the study;
- Hemorrhagic disorder (eg, factor deficiency, coagulopathy or platelet disorder) or a previous history of significant bleeding or hematoma after IM injections or venipuncture;
- Continued use of anticoagulants, such as coumarins and related anticoagulants (for example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban, dabigatran and edoxaban);
- Current suspected or known addiction to alcohol or drugs.
Key Trial Info
Start Date :
March 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
3371 Patients enrolled
Trial Details
Trial ID
NCT04801667
Start Date
March 20 2021
End Date
March 1 2023
Last Update
March 18 2022
Active Locations (1)
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1
Hospital do Rim - Fundação Oswaldo Ramos
São Paulo, Brazil