Clinical trial NCT04565522: Transmission of COVID-19 Virus Among Patients and Staff in Dialysis Centers
Official title: Transmission of COVID-19 Among Patients and Health Personnel in Dialysis Centers: a Cohort Prospective Study (DIAL-COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Dialysis
Nurse-Patient Relations
Keywords: contact mapping
Lead sponsor: A. Manzoni Hospital
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 2847
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients on haemodialysis
2. Patients on peritoneal dialysis
3. Healthcare professionals in charge of dialysis patients

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)

Eligibility criteria: 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

Primary outcomes:
measure: incident risk of COVID-19 infection
timeFrame: 1 year
Secondary outcomes:
measure: Evaluate the morbidity of COVID-19
timeFrame: 1 year
measure: Evaluate the mortality of COVID-19
timeFrame: 1 year
measure: Estimate the predictive role of comorbidities, inflammation indexes and therapy on the hospitalisation rate
timeFrame: Three months
measure: Estimate the predictive role of comorbidities, inflammation indexes and therapy on the mortality rate
timeFrame: Three months
measure: Evaluate the infective role of dialysis staff towards patients
timeFrame: 1 year
measure: Evaluate the infective role of patients towards dialysis staff
timeFrame: 1 year
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Cannizzaro
city: Catanzaro
country: Italy
facility: AOU Mater Domini
city: Firenze
country: Italy
facility: AOU Careggi
city: Foggia
country: Italy
facility: Policlinico
city: Mazara Del Vallo
country: Italy
facility: CEM-Mazara
city: Nuoro
country: Italy
facility: Osp. San Francesco
city: Pescia
country: Italy
facility: SOS Nefrologia di Pescia
city: Prato
country: Italy
facility: Ospedale di Santo Stefano
city: Roma
country: Italy
facility: Ambulatorio Dialisi di Tivoli
city: Roma
country: Italy
facility: Geramed Srl
Study officials:
References: