SARS-CoV InfectionKIDCOVNCT04705766
KIDney Injury in Times of COVID-19 (KIDCOV)
An observational study of SARS-CoV Infection and Covid19, run by University of California, San Francisco at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection, Covid19, Corona Virus Infection
- What is being tested?
- Urine Collection
- How many people
- 2,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2021to Mar 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Rush University
Chicago, Illinois, 60612
UCSF
San Francisco, California, 94143
About this study
Official title: The KIDCOV Study: ASSESSMENT of SARS-CoV-2 Without HOSPITALIZATION as a RISK FACTOR for ACUTE KIDNEY INJURY
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.
Read the detailed description
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.
- Being tested
- Urine Collection
- Keywords
- 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
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19, Coronavirus Infections, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine CollectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Negative | Control group to measure progression of AKI/kidney injury overtime Receives: Other: Urine Collection | |
| COVID-19 Positive | Study group to assess AKI trajectory/progression and associated risk factors of kidney injury with SARS-CoV-2 infection Receives: Other: Urine Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous, Quantitative KIT Score
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.
Measured: 1 year
Secondary outcomes (3)
Number of participants with a level of Kidney Injury Molecule-1 (KIM1) above 1 ng/ml
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).
Measured: 1 year
Number of participants with a level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) above 1 ng/ml
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).
Measured: 1 year
Number of participants with a level of soluble urokinase-type plasminogen activator receptor (suPAR) above 1 ng/ml
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Mar 2021
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center, University of Michigan, University of California
- Responsible party
- Sponsor
- Investigators
- Minnie Sarwal, M.D., Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705766
- Sponsor's protocol ID
- KIDCOV2020
- Acronym
- KIDCOV
- Status last verified
- Sep 2026
- First submitted
- 16 Dec 2020
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Watson D, Yang JYC, Sarwal RD, Sigdel TK, Liberto JM, Damm I, Louie V, Sigdel S, Livingstone D, Soh K, Chakraborty A, Liang M, Lin PC, Sarwal MM. A Novel Multi-Biomarker Assay for Non-Invasive Quantitative Monitoring of Kidney Injury. J Clin Med. 2019 Apr 12;8(4):499. doi: 10.3390/jcm8040499.
PubMed 31013714Yao 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.
PubMed 32364527Shang 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.
PubMed 32225175Roussel 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.
PubMed 32201354Manski 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.
PubMed 32377030Li 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.
PubMed 32375845Zhou 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.
PubMed 32171076Tang 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.
PubMed 32073213Cheng Y, Luo R, Wang K, Zhang M, Wang Z, Dong L, Li J, Yao Y, Ge S, Xu G. Kidney disease is associated with in-hospital death of patients with COVID-19. Kidney Int. 2020 May;97(5):829-838. doi: 10.1016/j.kint.2020.03.005. Epub 2020 Mar 20.
PubMed 32247631Baud D, Qi X, Nielsen-Saines K, Musso D, Pomar L, Favre G. Real estimates of mortality following COVID-19 infection. Lancet Infect Dis. 2020 Jul;20(7):773. doi: 10.1016/S1473-3099(20)30195-X. Epub 2020 Mar 12. No abstract available.
PubMed 32171390Meyerowitz-Katz G, Merone L. A systematic review and meta-analysis of published research data on COVID-19 infection fatality rates. Int J Infect Dis. 2020 Dec;101:138-148. doi: 10.1016/j.ijid.2020.09.1464. Epub 2020 Sep 29.
PubMed 33007452Serfozo P, Wysocki J, Gulua G, Schulze A, Ye M, Liu P, Jin J, Bader M, Myohanen T, Garcia-Horsman JA, Batlle D. Ang II (Angiotensin II) Conversion to Angiotensin-(1-7) in the Circulation Is POP (Prolyloligopeptidase)-Dependent and ACE2 (Angiotensin-Converting Enzyme 2)-Independent. Hypertension. 2020 Jan;75(1):173-182. doi: 10.1161/HYPERTENSIONAHA.119.14071. Epub 2019 Dec 2.
PubMed 31786979Yaqinuddin A, Kashir J. Innate immunity in COVID-19 patients mediated by NKG2A receptors, and potential treatment using Monalizumab, Cholroquine, and antiviral agents. Med Hypotheses. 2020 Jul;140:109777. doi: 10.1016/j.mehy.2020.109777. Epub 2020 Apr 22.
PubMed 32344314Ye M, Wysocki J, William J, Soler MJ, Cokic I, Batlle D. Glomerular localization and expression of Angiotensin-converting enzyme 2 and Angiotensin-converting enzyme: implications for albuminuria in diabetes. J Am Soc Nephrol. 2006 Nov;17(11):3067-75. doi: 10.1681/ASN.2006050423. Epub 2006 Oct 4.
PubMed 17021266Su H, Yang M, Wan C, Yi LX, Tang F, Zhu HY, Yi F, Yang HC, Fogo AB, Nie X, Zhang C. Renal histopathological analysis of 26 postmortem findings of patients with COVID-19 in China. Kidney Int. 2020 Jul;98(1):219-227. doi: 10.1016/j.kint.2020.04.003. Epub 2020 Apr 9.
PubMed 32327202
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The KIDCOV Study: ASSESSMENT of SARS-CoV-2 Without HOSPITALIZATION as a RISK FACTOR for ACUTE KIDNEY INJURY
- ClinicalTrials.gov ID
- NCT04705766
- Acronym / sponsor ID
- KIDCOV / KIDCOV2020
- Keywords
- SARS-CoV-2, Acute Kidney Injury, COVID-19, Coronaviurs, COVID-19 Infection, SARS-CoV-2 infection, Coronavirus infection, COVID-19 and Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Rush University Medical Center, University of Michigan, University of California
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Negative | – | Other: Urine CollectionControl group to measure progression of AKI/kidney injury overtime |
| COVID-19 Positive | – | Other: Urine CollectionStudy group to assess AKI trajectory/progression and associated risk factors of kidney injury with SARS-CoV-2 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine CollectionA 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. | Other | COVID-19 Negative, COVID-19 Positive |
Primary outcome
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.
3 secondary outcomes
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 Neutrophil Gelatinase-Associated Lipocalin (NGAL) above 1 ng/ml
Time frame: 1 year
Number of participants with a level of soluble urokinase-type plasminogen activator receptor (suPAR) above 1 ng/ml
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 31013714Watson D, Yang JYC, Sarwal RD, Sigdel TK, Liberto JM, Damm I, Louie V, Sigdel S, Livingstone D, Soh K, Chakraborty A, Liang M, Lin PC, Sarwal MM. A Novel Multi-Biomarker Assay for Non-Invasive Quantitative Monitoring of Kidney Injury. J Clin Med. 2019 Apr 12;8(4):499. doi: 10.3390/jcm8040499.
- Background: PubMed 32364527Yao 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.
- Background: PubMed 32225175Shang 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.
- Background: PubMed 32201354Roussel 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.
- Background: PubMed 32377030Manski 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.
- Background: PubMed 32375845Li 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.
- Background: PubMed 32171076Zhou 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.
- Background: PubMed 32073213Tang 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.
- Background: PubMed 32247631Cheng Y, Luo R, Wang K, Zhang M, Wang Z, Dong L, Li J, Yao Y, Ge S, Xu G. Kidney disease is associated with in-hospital death of patients with COVID-19. Kidney Int. 2020 May;97(5):829-838. doi: 10.1016/j.kint.2020.03.005. Epub 2020 Mar 20.
- Background: PubMed 32171390Baud D, Qi X, Nielsen-Saines K, Musso D, Pomar L, Favre G. Real estimates of mortality following COVID-19 infection. Lancet Infect Dis. 2020 Jul;20(7):773. doi: 10.1016/S1473-3099(20)30195-X. Epub 2020 Mar 12. No abstract available.
- Background: PubMed 33007452Meyerowitz-Katz G, Merone L. A systematic review and meta-analysis of published research data on COVID-19 infection fatality rates. Int J Infect Dis. 2020 Dec;101:138-148. doi: 10.1016/j.ijid.2020.09.1464. Epub 2020 Sep 29.
- Background: PubMed 31786979Serfozo P, Wysocki J, Gulua G, Schulze A, Ye M, Liu P, Jin J, Bader M, Myohanen T, Garcia-Horsman JA, Batlle D. Ang II (Angiotensin II) Conversion to Angiotensin-(1-7) in the Circulation Is POP (Prolyloligopeptidase)-Dependent and ACE2 (Angiotensin-Converting Enzyme 2)-Independent. Hypertension. 2020 Jan;75(1):173-182. doi: 10.1161/HYPERTENSIONAHA.119.14071. Epub 2019 Dec 2.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Minnie Sarwal, M.D., Ph.D. principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV Infection and Covid19, run by University of California, San Francisco at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous, Quantitative KIT Score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04705766, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.