KIDney Injury in Times of COVID-19 (KIDCOV) (KIDCOV)
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ClinicalTrials.gov Identifier: NCT04705766 |
Recruitment Status :
Recruiting
First Posted : January 12, 2021
Last Update Posted : April 29, 2022
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Condition or disease | Intervention/treatment |
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SARS-CoV Infection Covid19 Corona Virus Infection Acute Kidney Injury Kidney Injury | Other: Urine Collection |
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.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 2000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | The KIDCOV Study: ASSESSMENT of SARS-CoV-2 Without HOSPITALIZATION as a RISK FACTOR for ACUTE KIDNEY INJURY |
Actual Study Start Date : | March 1, 2021 |
Estimated Primary Completion Date : | March 2024 |
Estimated Study Completion Date : | March 2024 |

Group/Cohort | Intervention/treatment |
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COVID-19 Negative
Control group to measure progression of AKI/kidney injury overtime
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Other: 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. |
COVID-19 Positive
Study group to assess AKI trajectory/progression and associated risk factors of kidney injury with SARS-CoV-2 infection
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Other: 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. |
- Continuous, Quantitative KIT Score [ Time Frame: 1 year ]The 12-month continuous, quantitative Kidney Injury Test (KIT) score, measured on a scale of 0-100, where a higher urine-based KIT score correlates to worse kidney injury.
- Number of participants with a level of Kidney Injury Molecule-1 (KIM1) above 1 ng/ml [ Time Frame: 1 year ]Number of participants with a level of Kidney Injury Molecule-1 (KIM1) above 1 ng/ml, indicating the presence of kidney injury (higher value indicates worse kidney injury).
- Number of participants with a level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) above 1 ng/ml [ Time Frame: 1 year ]Number of participants with a level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) above 1 ng/ml, indicating the presence of kidney injury (higher value indicates worse kidney injury).
- Number of participants with a level of soluble urokinase-type plasminogen activator receptor (suPAR) above 1 ng/ml [ Time Frame: 1 year ]Number of participants with a level of soluble urokinase-type plasminogen activator receptor (suPAR), indicating the presence of kidney injury (higher value indicates worse kidney injury).
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Individuals with current SARS-CoV-2 test result recorded in their electronic medical record (EMR) at a participating Academic Medical Center (AMC). EMR must also record: contact information (for inviting participation and mailing urine kits), age (to confirm 18+ years), race and sex (to balance COVID- vs. COVID+ samples), current serum creatinine (an outcome), history of kidney transplant or dialysis (ineligible), and hospitalization up to 4 weeks after SARS-CoV-2 test (ineligible).
By restricting eligibility to individuals not hospitalized within the month after their PCR test, the investigators study people at low risk of kidney injury, as the investigators survey a population of otherwise well people. This reflects the public health goal: To estimate excess risk of kidney injury among the >80% of COVID19-infected individuals in whom the infection resolves without intensive healthcare intervention, in order to unveil an otherwise silent health burden on society.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705766
Contact: Minnie Sarwal, M.D., Ph.D. | 6503531532 | minnie.sarwal@ucsf.edu | |
Contact: James Cimino, BS | 4155140192 | jim.cimino@ucsf.edu |
United States, California | |
Dane Munar | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Dane Munar, BS 415-476-6978 dane.munar@ucsf.edu | |
Contact: James Cimino, BS (415)514-0192 jim.cimino@ucsf.edu | |
Principal Investigator: Minnie Sarwal, MD, PhD | |
United States, Illinois | |
Rush University | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Beata Samelko 312-942-0143 beata_samelko@rush.edu | |
Principal Investigator: Jochen Reiser, MD, PhD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Pennelope Kunkle 734-936-2813 penegonz@med.umich.edu | |
Principal Investigator: Salim Hayek, MD |
Principal Investigator: | Minnie Sarwal, M.D., Ph.D. | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT04705766 |
Other Study ID Numbers: |
KIDCOV2020 |
First Posted: | January 12, 2021 Key Record Dates |
Last Update Posted: | April 29, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Research records will be kept confidential to the extent permitted by law. Subjects will be identified by a code, and personal information from study records will not be released without the subject's permission. Study subjects will not be identified in any publication that may result from this study. However, the records may be reviewed under guidelines of the Federal Privacy Act by site monitors to assure the accuracy and completeness of study data. The investigators will make sure patient health information is removed from all the bio-samples and data obtained. The investigators will adhere to the NIH and HHS policies regarding the sharing of data and resources with the scientific community, publications, and intellectual property rights, and sharing of biomedical research resources. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
SARS-CoV-2 Acute Kidney Injury COVID-19 Coronaviurs COVID-19 Infection |
SARS-CoV-2 infection Coronavirus infection COVID-19 and Acute Kidney Injury SARS-CoV-2 & Kidney Injury Risk Factors Kidney Injury |
Infections Communicable Diseases COVID-19 Coronavirus Infections Severe Acute Respiratory Syndrome Acute Kidney Injury Wounds and Injuries Disease Attributes Pathologic Processes Respiratory Tract Infections Pneumonia, Viral |
Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Renal Insufficiency Kidney Diseases Urologic Diseases |