NCT04565522

Brief Summary

Patients on dialysis are at risk for several infectious diseases, since they have reduced immunological and have to regularly attend dialysis centres even if a pandemic is going on. Dialysis patients and healthcare professionals of dialysis centres can become infected one with the other. The incident risk of COVID-19 in dialysis centres is still unknown. Given the challenges of an early diagnosis of COVID-19, the likely transmission with outbreaks, the possibility of reciprocal transmission of the infection among patients and healthcare professionals, the frequent clinical severity of COVID-19 in dialysis patients because of the coexistence of several comorbidities, CONTACT TRACING could be an effective and efficient tool to contrast COVID-19 spreading in dialysis centres.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,847

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

10 active sites

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

September 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

September 23, 2020

Last Update Submit

February 16, 2023

Conditions

Covid19DialysisNurse-Patient Relations

Keywords

contact mapping

Outcome Measures

Primary Outcomes (1)

  • incident risk of COVID-19 infection

    incident risk of COVID-19 infection in dialysis patients and in related dialysis healthcare professionals

    1 year

Secondary Outcomes (6)

  • Evaluate the morbidity of COVID-19

    1 year

  • Evaluate the mortality of COVID-19

    1 year

  • Estimate the predictive role of comorbidities, inflammation indexes and therapy on the hospitalisation rate

    Three months

  • Estimate the predictive role of comorbidities, inflammation indexes and therapy on the mortality rate

    Three months

  • Evaluate the infective role of dialysis staff towards patients

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Hemodialysis or peritoneal dialysis patients

Hemodialysis or peritoneal dialysis Covid negative patients

Other: Prospective observation

dialysis staff healthcare professionals

dialysis staff Covid negative healthcare professionals

Other: Prospective observation

Interventions

Prospective observationOTHER

Prospective observation until one year follow-up

Hemodialysis or peritoneal dialysis patientsdialysis staff healthcare professionals

Eligibility Criteria

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

1. Patients on haemodialysis 2. Patients on peritoneal dialysis 3. Healthcare professionals in charge of dialysis patients

You may qualify if:

  • All the patients on haemodialysis or peritoneal dialysis giving their consent to participate
  • All healthcare professionals in charge of dialysis patients giving their consent to participate

You may not qualify if:

  • Dialysis patients or healthcare professionals who already have had Covid-19
  • Patients with kidney transplant
  • Patients with acute kidney injury (AKI) or on dialysis for less than 3 months
  • Life expectancy lower than 6 months
  • Patients already enrolled in other clinical trials
  • Absence of the consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Cannizzaro

Catania, Italy

Location

AOU Mater Domini

Catanzaro, Italy

Location

AOU Careggi

Florence, Italy

Location

Policlinico

Foggia, Italy

Location

CEM-Mazara

Mazara del Vallo, Italy

Location

Osp. San Francesco

Nuoro, Italy

Location

SOS Nefrologia di Pescia

Pescia, Italy

Location

Ospedale di Santo Stefano

Prato, Italy

Location

Ambulatorio Dialisi di Tivoli

Roma, Italy

Location

Geramed Srl

Roma, Italy

Location

Related Links

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
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 25, 2020

Study Start

October 1, 2020

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

IT(10)