Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04565522
Recruitment Status : Not yet recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Simeone Andrulli, MD, A. Manzoni Hospital

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.


Condition or disease Intervention/treatment
Covid19 Dialysis Nurse-Patient Relations Other: Prospective observation

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)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transmission of COVID-19 Among Patients and Health Personnel in Dialysis Centers: a Cohort Prospective Study (DIAL-COVID-19)
Estimated Study Start Date : September 21, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Group/Cohort Intervention/treatment
Hemodialysis or peritoneal dialysis patients
Hemodialysis or peritoneal dialysis Covid negative patients
Other: Prospective observation
Prospective observation until one year follow-up

dialysis staff healthcare professionals
dialysis staff Covid negative healthcare professionals
Other: Prospective observation
Prospective observation until one year follow-up




Primary Outcome Measures :
  1. incident risk of COVID-19 infection [ Time Frame: 1 year ]
    incident risk of COVID-19 infection in dialysis patients and in related dialysis healthcare professionals


Secondary Outcome Measures :
  1. Evaluate the morbidity of COVID-19 [ Time Frame: 1 year ]
    Evaluate the morbidity (hospitalisation rate) of COVID-19 in the two subject categories

  2. Evaluate the mortality of COVID-19 [ Time Frame: 1 year ]
    Evaluate the mortality rate of COVID-19 in the two subject categories

  3. Estimate the predictive role of comorbidities, inflammation indexes and therapy on the hospitalisation rate [ Time Frame: Three months ]
    Estimate the predictive role of comorbidities, inflammation indexes and therapy on the hospitalisation rate in the three months after COVID-19 diagnosis

  4. Estimate the predictive role of comorbidities, inflammation indexes and therapy on the mortality rate [ Time Frame: Three months ]
    Estimate the predictive role of comorbidities, inflammation indexes and therapy on the mortality rate in the three months after COVID-19 diagnosis

  5. Evaluate the infective role of dialysis staff towards patients [ Time Frame: 1 year ]
    Evaluate the infective role of dialysis staff towards patients over one year follow-up

  6. Evaluate the infective role of patients towards dialysis staff [ Time Frame: 1 year ]
    Evaluate the infective role of patients towards dialysis staff over one year follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients on haemodialysis
  2. Patients on peritoneal dialysis
  3. Healthcare professionals in charge of dialysis patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565522


Contacts
Layout table for location contacts
Contact: Simeone Andrulli, MD +393472217802 simeone.andrulli@statgate.it

Locations
Layout table for location information
Italy
AOU Mater Domini
Catanzaro, Italy
Contact: PierAngela Presta, MD       piera.presta@gmail.com   
Sponsors and Collaborators
Simeone Andrulli, MD
Additional Information:
Layout table for additonal information
Responsible Party: Simeone Andrulli, MD, Principal Investigator, A. Manzoni Hospital
ClinicalTrials.gov Identifier: NCT04565522    
Other Study ID Numbers: DIAL-COVID-19
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Simeone Andrulli, MD, A. Manzoni Hospital:
contact mapping