Noncoding RNAs in COVID-19 and COVID-19 Related Kidney Dy... | NCT04381351

Studies
Noncoding RNAs in COVID-19 and COVID-19 Related Kidney Dysfunction

NCT04381351

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Unknown status

Last Update Posted

May 27, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 16, 2020Actual

Primary Completion Date

Mar 1, 2021Estimated

Completion Date

Jul 31, 2021Estimated

First Submitted Date

May 7, 2020

First Submission Date that Met QC Criteria

May 7, 2020

First Posted Date

May 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2020

Last Update Posted Date

May 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klinik für Anästhesiologie, Principal Investigator, Heinrich-Heine University, DuesseldorfPrincipal Investigator

Lead Sponsor

Heinrich-Heine University, DuesseldorfOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, critically ill patients with highly suspected or confirmed COVID-19 will be included. Main goal is the identification of noncoding RNAs in COVID-19 associated organ dysfunction with an emphasis on acute kidney injury.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
predicitive value of noncoding RNAs in COVID-19 associated organ dysfunction		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COVID-19

Exclusion Criteria:

kidney transplantation
eGFR < 30 ml/Min
dialysis within last 90 days
chronic dialysis
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

COVID-19 patients with critical illness on ICU.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Anästhesiologie	Recruiting	Düsseldorf		40225	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided