NCT04367714

Brief Summary

Determination of IgM and IgG antibodies against SARS-CoV-2 in dialysis patients by continous monitoring in the period from March 2020 to december 2020

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

April 27, 2020

Last Update Submit

December 29, 2020

Conditions

COVIDTerminal Renal Insufficiency

Keywords

COVID-19CKD 5

Outcome Measures

Primary Outcomes (1)

  • AAntibody response

    IgM and IgG against SARS-CoV-2

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dilaysis patients on 3 Danish center in Jutland

You may qualify if:

  • Dialysis

You may not qualify if:

  • Not willing to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Godstrup Hospital

Herning, 7400, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples for determination of antibodies, cytokines, RNA and DNA

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Frank Mose, MD

CONTACT

+4528531257frchri@rm.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 29, 2020

Study Start

March 15, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)