KIDney Injury in Times of COVID-19 (KIDCOV)

Официальное название

The KIDCOV Study: ASSESSMENT of SARS-CoV-2 Without HOSPITALIZATION as a RISK FACTOR for ACUTE KIDNEY INJURY

Обзор

There is an unmet need to evaluate the impact of sub-clinical/mild COVID19 disease in the outpatient setting on prevalent and incident renal injury, as this data is currently unavailable. To capture the diversity of race/ethnic risk and COVID19 related municipal shelter-in-place guidance, the investigators will enroll COVID19-negative and COVID19-positive samples balanced by race/ethnicity from 3 different states, California, Michigan, and Illinois. Study endpoints will be assayed from urine samples mailed to the study team at 2, 6, and 12 months after their date of PCR test, with no requirement for these individuals to leave their homes to participate.

Подробное описание

KIDCOV is a longitudinal cohort study that will prospectively follow cohorts of COVID19-negative and COVID19-positive adults for episodes of kidney injury over a 12-months period. Study candidates will be identified via site-specific electronic medical records (EMR) at seven academic medical centers in the U.S. within 4 weeks of a PCR-based test for SARS-Cov2. Screen-positive individuals will be contacted by email or text and invited to complete an online consent form documenting their willingness to participate. Participation will involve completion of questionnaires and return of urine samples in mailed collection kits at 2, 6, and 12 months after their date of PCR test. The primary endpoint will be the urine-based KIT Score, based on the composite measurement of multiple DNA, protein and metabolite urinary biomarkers (reference). Secondary endpoints include NGAL and KIM-1 urinary biomarkers for kidney injury assessment.

Early detection of new or worsening kidney injury is urgently needed in order to implement preventative measures and target therapeutics that can minimize excess post-COVID19 kidney damage. A complete and standardized understanding of the trajectory and risk factors for kidney injury associated with COVID19+ disease is critical to informing the design and implementation of preventative and therapeutic strategies for COVID19-mediated kidney injury.

Вмешательства

• Другое Urine Collection
  A urine collection kit will be mailed to subjects' residence at 3 different timepoints over the course of 1 year to be returned to study team, upon which KIT score and other biomarkers will be assessed as outlined in the study design.

Первичные конечные точки

• Continuous, Quantitative KIT Score [Срок оценки: 1 year]

Вторичные конечные точки (3)

• Number of participants with a level of Kidney Injury Molecule-1 (KIM1) above 1 ng/ml [Срок оценки: 1 year]
• Number of participants with a level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) above 1 ng/ml [Срок оценки: 1 year]
• Number of participants with a level of soluble urokinase-type plasminogen activator receptor (suPAR) above 1 ng/ml [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Result of PCR-based COVID-19 test conducted in the past 4 weeks posted in EMR of participating AMC
• Age 18 years or older at enrollment
• Race/ethnicity, sex, age, and phone and/or home/email address provided

Критерии исключения

• Failure of a candidate participant to give written informed consent to comply with the study protocol
• Hospitalization up to 4 weeks after SARS-CoV-2 test
• History of kidney transplant
• History of dialysis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• UCSF — San Francisco
• Rush University — Chicago
• University of Michigan — Ann Arbor

Публикации

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• Yao Z, Zheng Z, Wu K, Junhua Z. Immune environment modulation in pneumonia patients caused by coronavirus: SARS-CoV, MERS-CoV and SARS-CoV-2. Aging (Albany NY). 2020 May 2;12(9):7639-7651. doi: 10.18632/aging.103101. Epub 2020 May 2. PMID 32364527
• Shang J, Ye G, Shi K, Wan Y, Luo C, Aihara H, Geng Q, Auerbach A, Li F. Structural basis of receptor recognition by SARS-CoV-2. Nature. 2020 May;581(7807):221-224. doi: 10.1038/s41586-020-2179-y. Epub 2020 Mar 30. PMID 32225175
• Roussel Y, Giraud-Gatineau A, Jimeno MT, Rolain JM, Zandotti C, Colson P, Raoult D. SARS-CoV-2: fear versus data. Int J Antimicrob Agents. 2020 May;55(5):105947. doi: 10.1016/j.ijantimicag.2020.105947. Epub 2020 Mar 19. PMID 32201354
• Manski CF, Molinari F. Estimating the COVID-19 infection rate: Anatomy of an inference problem. J Econom. 2021 Jan;220(1):181-192. doi: 10.1016/j.jeconom.2020.04.041. Epub 2020 May 6. PMID 32377030
• Li X, Ma X. Acute respiratory failure in COVID-19: is it "typical" ARDS? Crit Care. 2020 May 6;24(1):198. doi: 10.1186/s13054-020-02911-9. PMID 32375845
• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. PMID 32171076
• Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13. PMID 32073213

Идентификаторы

NCT: NCT04705766 · KIDCOV2020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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