NCT04347824

Brief Summary

This non-interventional, observational study retrospectively (and in parts prospectively) investigates, if a Covid-19 associated Nephritis, diagnosed by Urine-dipstick and further Urine-analyses on addmission, can help to predict later complications, adverse outcomes and later need for ICU-capacity in Covid-19 patients as well as can guide preventive strategies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

April 9, 2020

Last Update Submit

April 27, 2021

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

  • Time to Disease-Aggravation

    Time (in days) from hospital admission to transferral to ICU (ICU level high) OR time (in days) from Hospital Admission to Death

    during first 10 days after admission to hospital

Secondary Outcomes (3)

  • Complications

    during first 10 days after admission to hospital

  • Resources

    during hospital stay, up to 2 months

  • Blood-test

    during hospital stay, up to 2 months

Study Arms (3)

low risk

This group has a normal urine status on admission to hospital. Abnormal urine status is defined anuric OR as 2\* or more of the following findings: 1. urine osmolarity below normal values 2. leukozyturia 3. hematuria 4. albuminuria/ proteinuria \* if urine is positive for nitrite or bacteria, abnormal urine status is defined as 3 or more of the findings.

intermediate risk

This group has an abnormal urine status on admission to hospital WITHOUT serum-albumin below 2.0 g/dl AND WITHOUT antithrombin III level below 70%.

high risk

This group has an abnormal urine status on admission to hospital PLUS serum-albumin below 2.0 g/dl OR antithrombin III level below 70%.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This observational study investigates the outcome of patients with approved Covid-19 diagnosis.

You may qualify if:

  • approved Covid-19 diagnosis (by PCR or CT-scan);
  • urine status during hospital stay
  • Patient expressed willingness to participate in observational studies during hospital admission.

You may not qualify if:

  • \) Patient expressed unwillingness to participate in observational studies during hospital admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Goettingen

Göttingen, Germany

Location

Related Publications (3)

  • Gross O, Moerer O, Weber M, Huber TB, Scheithauer S. COVID-19-associated nephritis: early warning for disease severity and complications? Lancet. 2020 May 16;395(10236):e87-e88. doi: 10.1016/S0140-6736(20)31041-2. Epub 2020 May 6. No abstract available.

    PMID: 32423587BACKGROUND

  • Puelles VG, Lutgehetmann M, Lindenmeyer MT, Sperhake JP, Wong MN, Allweiss L, Chilla S, Heinemann A, Wanner N, Liu S, Braun F, Lu S, Pfefferle S, Schroder AS, Edler C, Gross O, Glatzel M, Wichmann D, Wiech T, Kluge S, Pueschel K, Aepfelbacher M, Huber TB. Multiorgan and Renal Tropism of SARS-CoV-2. N Engl J Med. 2020 Aug 6;383(6):590-592. doi: 10.1056/NEJMc2011400. Epub 2020 May 13. No abstract available.

    PMID: 32402155BACKGROUND

  • Gross O, Moerer O, Rauen T, Bockhaus J, Hoxha E, Jorres A, Kamm M, Elfanish A, Windisch W, Dreher M, Floege J, Kluge S, Schmidt-Lauber C, Turner JE, Huber S, Addo MM, Scheithauer S, Friede T, Braun GS, Huber TB, Blaschke S. Validation of a Prospective Urinalysis-Based Prediction Model for ICU Resources and Outcome of COVID-19 Disease: A Multicenter Cohort Study. J Clin Med. 2021 Jul 9;10(14):3049. doi: 10.3390/jcm10143049.

    PMID: 34300217DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 15, 2020

Study Start

April 27, 2020

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

DE(1)