Predict Adverse Events by Covid-19 Nephritis

Covid-19 Clinical Trial

Official title:

Covid-19 Associated Nephritis as Early Predictor for Complicated Course of Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347824
• Other study ID #: UMG_Co19-Nephritis
• Status: Completed
• Start date: April 27, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: University Hospital Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Parameters predicting risks for Covid-19 patients are urgently sought. The current study investigates, if Covid-19 associated nephritis indicating systemic cappillary leak syndrome/severe nephrotic syndrome could be the major driver for complications, predictor for respiratory failure and later need for ICU, and death.

This study intends to generate an algorithm for University hospitals, which allows early detection of Covid-19 associated nephritis and to classify the risk for respiratory decompensation by quantification of severity of nephrotic syndrome.

The rationale of the observational study can be explained by the hypothesis that Covid-19 causes Nephritis: Podocytes express high levels of ACE2, which makes the glomerulus to a target for Covid-19. Other zoonoses, such as Hanta-virus, are a well described cause of nephrotic syndrome inducing cardiopulmonary syndrome. Life-threatening complications of severe nephrotic syndrome are well known as are preventive therapies.

Covid-19 ICU patients with nephritis have

1. pulmonary interstitial edema, possibly also due to capillary leak/ nephrotic syndrome;

2. immune-incompetence, due to renal loss of immunoglobulins;

3. circulatory insufficiency, due to hypalbuminemia (which might explain sudden deaths in the geriatric population);

4. less response to some medications caused by impaired plasma protein binding of drugs due to hypalbuminemia and renal loss;

5. thromboembolic events, due to antithrombin-deficiency (which might explain lethality in oligo-symptomatic young patients).

In conclusion, ACE2 in the respiratory tract is the gateway for Covid-19 for infection, however, the study postulates that Covid-19 associated nephritis and severe cappillary leak/nephrotic syndrome is a major driver of adverse outcome. If confirmed by others, these findings and algorithm would allow early prediction of later need for ICU-capacity, better allocation of patients for clinical trials, and preventive strategies focused on the nephrotic syndrome including treatment, which can save lives. Same might apply for risk-evaluation of outpatients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. approved Covid-19 diagnosis (by PCR or CT-scan);

2. urine status during hospital stay

3. Patient expressed willingness to participate in observational studies during hospital admission.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Covid-19
• Nephritis

Locations

Country	Name	City	State
Germany	University Medical Center Goettingen	Göttingen

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Goettingen	Transplantationszentrum Köln-Merheim, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Aachen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

Puelles VG, Lütgehetmann M, Lindenmeyer MT, Sperhake JP, Wong MN, Allweiss L, Chilla S, Heinemann A, Wanner N, Liu S, Braun F, Lu S, Pfefferle S, Schröder 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications	Number of Complications are defined as; Need of transferral to "ICU low" (ICU level 1)*; Need of transferral to "ICU high" (ICU level 3)*; Need of mechanical ventilation* OR; Need for renal replacement therapy* OR; Need of extracorporeal membrane oxygenation* OR; Death * in the first 10 days after admission to hospital	during first 10 days after admission to hospital
Secondary	Resources	Time on "ICU low" (in days),; Time on "ICU high" (in days),; Time on invasive mechanical ventilation (in days); Time on extracorporeal membrane oxygenation (in days); Time on renal replacement therapy (in days)	during hospital stay, up to 2 months
Secondary	Blood-test	lowest serum-albumin; lowest antithrombin III	during hospital stay, up to 2 months