Covid19DIAL-COVID-19NCT04565522
Transmission of COVID-19 Virus Among Patients and Staff in Dialysis Centers
An observational study of Covid19 and Dialysis, run by Simeone Andrulli, MD at 10 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Dialysis, Nurse-Patient Relations
- What is being tested?
- Prospective observation
- How many people
- 2,847 participants
- Where
- 10 sitesItaly
- Study dates
- 1 Oct 2020to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients on haemodialysis 2. Patients on peritoneal dialysis 3. Healthcare professionals in charge of dialysis patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Cannizzaro
Catania
AOU Mater Domini
Catanzaro
AOU Careggi
Florence
Policlinico
Foggia
CEM-Mazara
Mazara del Vallo
Osp. San Francesco
Nuoro
SOS Nefrologia di Pescia
Pescia
Ospedale di Santo Stefano
Prato
Ambulatorio Dialisi di Tivoli
Roma
Geramed Srl
Roma
About this study
Official title: Transmission of COVID-19 Among Patients and Health Personnel in Dialysis Centers: a Cohort Prospective Study (DIAL-COVID-19)
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.
Read the 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:
- Daily for healthcare professionals
- At every dialysis session for haemodialysis patients
- 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:
- Diagnosis of symptomatic COVID-19 with or without hospitalisation
- Respiratory insufficiency with the need of CPAP or mechanical ventilation
- 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:
- Estimate the incidence, morbidity and mortality of COVID-19 in the two categories
- Estimate predictors and/or confounders associated with the incidence of the three study outcomes (infection, morbidity and mortality)
- Conditions
- Covid19, Dialysis, Nurse-Patient Relations
- Being tested
- Prospective observation
- Keywords
- contact mapping
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective observationOther
Prospective observation until one year follow-up
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis or peritoneal dialysis patients | Hemodialysis or peritoneal dialysis Covid negative patients Receives: Other: Prospective observation | |
| dialysis staff healthcare professionals | dialysis staff Covid negative healthcare professionals Receives: Other: Prospective observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
incident risk of COVID-19 infection
incident risk of COVID-19 infection in dialysis patients and in related dialysis healthcare professionals
Measured: 1 year
Secondary outcomes (6)
Evaluate the morbidity of COVID-19
Evaluate the morbidity (hospitalisation rate) of COVID-19 in the two subject categories
Measured: 1 year
Evaluate the mortality of COVID-19
Evaluate the mortality rate of COVID-19 in the two subject categories
Measured: 1 year
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
Measured: Three months
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
Measured: Three months
Evaluate the infective role of dialysis staff towards patients
Evaluate the infective role of dialysis staff towards patients over one year follow-up
Measured: 1 year
Evaluate the infective role of patients towards dialysis staff
Evaluate the infective role of patients towards dialysis staff over one year follow-up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Oct 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,847 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simeone Andrulli, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Simeone Andrulli, MD, A. Manzoni Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565522
- Sponsor's protocol ID
- DIAL-COVID-19
- Acronym
- DIAL-COVID-19
- Status last verified
- Feb 2023
- First submitted
- 23 Sep 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmission of COVID-19 Among Patients and Health Personnel in Dialysis Centers: a Cohort Prospective Study (DIAL-COVID-19)
- ClinicalTrials.gov ID
- NCT04565522
- Acronym / sponsor ID
- DIAL-COVID-19 / DIAL-COVID-19
- Conditions
- Covid19, Dialysis, Nurse-Patient Relations
- Keywords
- contact mapping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,847 participants (actual)
- Lead sponsor
- Simeone Andrulli, MDUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Daily for healthcare professionals
- At every dialysis session for haemodialysis patients
- 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:
- Diagnosis of symptomatic COVID-19 with or without hospitalisation
- Respiratory insufficiency with the need of CPAP or mechanical ventilation
- 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:
- Estimate the incidence, morbidity and mortality of COVID-19 in the two categories
- Estimate predictors and/or confounders associated with the incidence of the three study outcomes (infection, morbidity and mortality)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis or peritoneal dialysis patients | – | Other: Prospective observationHemodialysis or peritoneal dialysis Covid negative patients |
| dialysis staff healthcare professionals | – | Other: Prospective observationdialysis staff Covid negative healthcare professionals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients on haemodialysis 2. Patients on peritoneal dialysis 3. Healthcare professionals in charge of dialysis patients
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective observationProspective observation until one year follow-up | Other | Hemodialysis or peritoneal dialysis patients, dialysis staff healthcare professionals |
Primary outcome
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
6 secondary outcomes
Evaluate the morbidity of COVID-19
Time frame: 1 year
Evaluate the mortality of COVID-19
Time frame: 1 year
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 mortality rate
Time frame: Three months
Evaluate the infective role of dialysis staff towards patients
Time frame: 1 year
Evaluate the infective role of patients towards dialysis staff
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Associazione Italiana Ricercare per Curare ODV ETS (AIRpC)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Dialysis, run by Simeone Andrulli, MD at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incident risk of COVID-19 infection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.