Predict Adverse Events by Covid-19 Nephritis

Completed

• Conditions: Covid-19

• Registration Number: NCT04347824
• Lead Sponsor: University Hospital Goettingen

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-15
• Study Start: 2020-04-27
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Disease-Aggravation	during first 10 days after admission to hospital	Time (in days) from hospital admission to transferral to ICU (ICU level high) OR time (in days) from Hospital Admission to Death

Secondary Outcome Measures

Name	Time	Method
Complications	during first 10 days after admission to hospital	Number of Complications are defined as; 1. Need of transferral to "ICU low" (ICU level 1)\*; 2. Need of transferral to "ICU high" (ICU level 3)\*; 3. Need of mechanical ventilation\* OR; 4. Need for renal replacement therapy\* OR; 5. Need of extracorporeal membrane oxygenation\* OR; 6. Death \* in the first 10 days after admission to hospital
Resources	during hospital stay, up to 2 months	* 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)
Blood-test	during hospital stay, up to 2 months	* lowest serum-albumin; * lowest antithrombin III

Trial Locations

Locations (1)

University Medical Center Goettingen; 🇩🇪 Göttingen, Germany