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

Covid19 Clinical Trial

— DIAL-COVID-19  

Official title:

Transmission of COVID-19 Among Patients and Health Personnel in Dialysis Centers: a Cohort Prospective Study (DIAL-COVID-19)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565522
• Other study ID #: DIAL-COVID-19
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2023
• Source: A. Manzoni Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2847
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Dialysis
• Nurse-Patient Relations

Intervention

Other:
• Prospective observation
Prospective observation until one year follow-up

Locations

Country	Name	City	State
Italy	Cannizzaro	Catania
Italy	AOU Mater Domini	Catanzaro
Italy	AOU Careggi	Firenze
Italy	Policlinico	Foggia
Italy	CEM-Mazara	Mazara Del Vallo
Italy	Osp. San Francesco	Nuoro
Italy	SOS Nefrologia di Pescia	Pescia
Italy	Ospedale di Santo Stefano	Prato
Italy	Ambulatorio Dialisi di Tivoli	Roma
Italy	Geramed Srl	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Simeone Andrulli, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incident risk of COVID-19 infection	incident risk of COVID-19 infection in dialysis patients and in related dialysis healthcare professionals	1 year
Secondary	Evaluate the morbidity of COVID-19	Evaluate the morbidity (hospitalisation rate) of COVID-19 in the two subject categories	1 year
Secondary	Evaluate the mortality of COVID-19	Evaluate the mortality rate of COVID-19 in the two subject categories	1 year
Secondary	Estimate the predictive role of comorbidities, inflammation indexes and therapy on the hospitalisation rate	Estimate the predictive role of comorbidities, inflammation indexes and therapy on the hospitalisation rate in the three months after COVID-19 diagnosis	Three months
Secondary	Estimate the predictive role of comorbidities, inflammation indexes and therapy on the mortality rate	Estimate the predictive role of comorbidities, inflammation indexes and therapy on the mortality rate in the three months after COVID-19 diagnosis	Three months
Secondary	Evaluate the infective role of dialysis staff towards patients	Evaluate the infective role of dialysis staff towards patients over one year follow-up	1 year
Secondary	Evaluate the infective role of patients towards dialysis staff	Evaluate the infective role of patients towards dialysis staff over one year follow-up	1 year

External Links

•   Associazione Italiana Ricercare per Curare ODV ETS (AIRpC)