Datos solicitados: Valores de Complemento para pacientes que necesitaron UVI debido a COVID-19
Objetivo del proyecto: Identificar el papel del sistema del complemento en la respuesta hiperinflamatoria de pacientes de COVID-19.
Name: Deborah Wenkert
Institution: Wenkert & Young, LLC, Thousand Oaks, CA
Description of project:
Primary aim: To determine if complement consumption occurs as part of the hyperinflammatory response to COVID-19
– To compare the levels and time course of serum complement biomarkers in subjects with different clinical outcomes from COVID-19.
– To compare the levels and time course of complement biomarkers in subjects with COVID-19 to patient progression and outcome data (including anti-viral antibody titers and viral load, if available).
Terms of collaboration:
The requester is very flexible as to the terms of collaboration. She is open to a long-term collaboration and to co-authorship of eventual papers.
Detailed description of data:
This is a retrospective, de-identified request for laboratory and clinical data, including complement biomarkers, from the time of acquisition of complement biomarker measurements, of patients with COVID-19 who required ICU admission. The data would need to include at least 5 patients while experiencing a hyperinflammatory response to COVID-19. The ideal dataset would include all variables indicated below, but partial datasets would also be useful.
Inclusion criteria: Patients with COVID-19 who:
1. Required hospitalization
2. Have data available on complement biomarkers
3. Have data available on clinical and laboratory course and past medical history
4. At least 5 patients whose hospital course was complicated by a hyperinflammatory state at the time of complement biomarker measurements
Exclusion criteria: Patients with:
1. Treatment with a complement inhibitor within 5 half-lives or 2 weeks, whichever is longer, of the time of the complement measurements.
2. Known immunodeficiency syndrome
3. Known underlying disorder involving alterations in complement levels (e.g., systemic lupus erythematosus)
Linked, de-identified data, already available on any complement markers (e.g., C3, C4, CH50, C1q, and/or complement split products) will be compared to the other available clinical information (laboratory and clinical). Data, at minimum, would include complement levels, inflammatory markers, clinical course (ECMO, Ventilator, current medications, coexisting medical conditions). Ideally, the data would include complement biomarker levels, Demographics/Medical History, Physical Examination, Height and Weight, Clinical status–interim change, Vital Signs, Prior/Concomitant Medications, Clinical Labs, O2 requirement, Average SpO2, Ventilator settings (on day of admission, and maximum interim setting) H-score (for hemophagocytic lymphohistiocytosis).
A full protocol originally created for a prospective study (that is no longer planned) would be easily modifiable for use in this retrospective study once a collaborator with the necessary data (complement biomarkers) has been identified.
Status of ethical approval:
The requester will work with anonymized datasets, and does not need ethical approval from their institution. They are willing to work with the data provider to obtain any necessary ethical approvals to collect the data.
Nota: En caso necesario, Crowdfight COVID-19 puede proporcionar ayuda para el procesamiento, preparación o envío de los datos. Esto incluye asesoramiento técnico, apoyo de expertos en bases de datos, o voluntarios que realicen tareas manuales (organización de datos, etc.).