Clinical Trial: Molecular Pathological Analysis of Biopsy and Autopsy Specimens from Patients Who Developed Adverse Events following COVID-19 Infection and/or COVID-19 Vaccination (Japan)

Tokyo, Feb. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060702) titled 'Molecular Pathological Analysis of Biopsy and Autopsy Specimens from Patients Who Developed Adverse Events following COVID-19 Infection and/or COVID-19 Vaccination' on Feb. 18.

Study Type: Observational

Primary Sponsor: Institute - Japanese Society for Vaccine-related Complications

Condition: Condition - Adverse events following COVID-19 infection and/or COVID-19 vaccination Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To elucidate the molecular pathogenesis by detecting residual vaccine-derived nucleic acids or proteins using histological and molecular biological methods in cases that developed adverse events after COVID-19 infection and/or COVID-19 vaccination and underwent biopsy, as well as in fatal cases with sequelae that underwent autopsy. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients who have provided written informed consent form by signing a consent form to participate in this research. In case of deceased subjects, informed consent will be obtained from a legally authorized representative. 2.Patients who have developed adverse events after COVID-19 infection and/or COVID-19 vaccination, or after blood transfusion from a donor who has received a COVID-19 vaccine. 3.Patients who have specimens collected and stored during routine clinical practice or specimens preserved by autopsy; patients who are able to provide blood samples or biopsy specimens collected in addition to routine clinical practice, or surgical specimens obtained during routine clinical practice; or patients who are able to newly provide urine or sweat samples. 4.No upper or lower age limit is set. Key exclusion criteria - None. Target Size - 10

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 02 Month 06 Day Date of IRB - 2026 Year 02 Month 13 Day Anticipated trial start date - 2026 Year 02 Month 15 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069439

Disclaimer: Curated by HT Syndication.