Transmission of COVID-19 Virus Among Patients and Staff in Dialysis Centers

Completed

• Conditions: Covid19; Dialysis; Nurse-Patient Relations
• Interventions: Other: Prospective observation

• Registration Number: NCT04565522
• Lead Sponsor: Simeone Andrulli, MD

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.

Detailed Description

Patients on dialysis are at risk for several infectious diseases, since they have reduced immunological and have to regularly attend dialysis centres from once to thrice a week depending on their residual renal function 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. This modality keeps trace of the contacts the new COVID-19 case have had and allow the identification of other possible cases in that outbreak

Contact tracing is the key tool to detect and trace COVID-19 cases among patients and health care professionals, i.e. the space-time mapping of the contacts among these two categories:

1. Daily for healthcare professionals

2. At every dialysis session for haemodialysis patients

3. At every hospital visit for patients on peritoneal dialysis

Maximum follow will be up to 12 months excepting in those patients who develop a COVID-19-related clinically significant event:

1. Diagnosis of symptomatic COVID-19 with or without hospitalisation

2. Respiratory insufficiency with the need of CPAP or mechanical ventilation

3. Death associated or related to COVID-19

In the participating centres, the enrolment of patients and healthcare professionals will be prospective, progressive and competitive till the number of cases of COVD-19 will reach 200 subjects. If study participation will be 10% and COVID-19 will be taken by 4% of the patients with no prior exposure to COVID-19, we can estimate to enrol 5000 subjects (dialysis patients and healthcare professionals) over a period of 12 months in 50-150 centres. The length of the enrolment period of 6-12 months will depend also on future evolution of the pandemic in the Italian regions that have not been massively hit by the infection.

Study data will be stored on a web-database, which will be created on purpose. Privacy protection of patients and health care professionals will be pursued and granted by anonymous data collection.

Given the longitudinal and prospective design of the study, Kaplan-Meier curves will be used to describe the incidence of COVID-19 infection and the survival of dialysis patients and their healthcare professionals.

Cox multivariate analysis will be used to:

1. Estimate the incidence, morbidity and mortality of COVID-19 in the two categories

2. Estimate predictors and/or confounders associated with the incidence of the three study outcomes (infection, morbidity and mortality)

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-25
• Study Start: 2020-10-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2847

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemodialysis or peritoneal dialysis patients	Prospective observation	Hemodialysis or peritoneal dialysis Covid negative patients
dialysis staff healthcare professionals	Prospective observation	dialysis staff Covid negative healthcare professionals

Primary Outcome Measures

Name	Time	Method
incident risk of COVID-19 infection	1 year	incident risk of COVID-19 infection in dialysis patients and in related dialysis healthcare professionals

Secondary Outcome Measures

Name	Time	Method
Evaluate the infective role of patients towards dialysis staff	1 year	Evaluate the infective role of patients towards dialysis staff over one year follow-up
Evaluate the morbidity of COVID-19	1 year	Evaluate the morbidity (hospitalisation rate) of COVID-19 in the two subject categories
Evaluate the mortality of COVID-19	1 year	Evaluate the mortality rate of COVID-19 in the two subject categories
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 hospitalisation rate in the three months after COVID-19 diagnosis
Estimate the predictive role of comorbidities, inflammation indexes and therapy on the mortality rate	Three months	Estimate the predictive role of comorbidities, inflammation indexes and therapy on the mortality rate in the three months after COVID-19 diagnosis
Evaluate the infective role of dialysis staff towards patients	1 year	Evaluate the infective role of dialysis staff towards patients over one year follow-up

Trial Locations

Locations (10)

AOU Mater Domini; 🇮🇹 Catanzaro, Italy

Ospedale di Santo Stefano; 🇮🇹 Prato, Italy

Cannizzaro; 🇮🇹 Catania, Italy

SOS Nefrologia di Pescia; 🇮🇹 Pescia, Italy

AOU Careggi; 🇮🇹 Firenze, Italy

Osp. San Francesco; 🇮🇹 Nuoro, Italy

CEM-Mazara; 🇮🇹 Mazara Del Vallo, Italy

Ambulatorio Dialisi di Tivoli; 🇮🇹 Roma, Italy

Policlinico; 🇮🇹 Foggia, Italy

Geramed Srl; 🇮🇹 Roma, Italy