Covid19NCT04685447
Effects of Different Dialysis Strategies on Inflammation in COVID-19 Maintenance Hemodialysis Patients
A study testing Expanded Hemodialysis for Covid19 maintenance hemodialysis patients and Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients in people with Covid19 and Hemodialysis Complication, run by Universita degli Studi di Genova at 2 sites in Italy.
Trial summary
In the course of Coronavirus Disease-19 (COVID-19) uncontrolled inflammation has been related to disease severity and unfavorable outcomes. Here, the investigators study the longitudinal changes of pro- and anti-inflammatory markers in a population of patients undergoing maintenance hemodialysis (HD) affected by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Hemodialysis Complication, Inflammatory Response
- What is being tested?
- Expanded Hemodialysis for Covid19 maintenance hemodialysis patients and Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Mar 2020to 1 May 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients undergoing maintenance hemodialysis
- Confirmed severe acute respiratory syndrome-coronavirus2 infection
Who cannot join
- Acute kidney injury
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Ospedale IRCCS San Martino
Genova
Policlinico IRCCS Ospedale San Matteo
Pavia
About this study
Official title: Inflammatory Cytokine Profile in Maintenance Hemodialysis Patients Affected by COVID-19: Effects of 2 Different Dialysis Strategies
In the course of Coronavirus Disease-19 (COVID-19) uncontrolled inflammation has been related to disease severity and unfavorable outcomes.
Here, the investigators study the longitudinal changes of pro- and anti-inflammatory markers in a population of patients undergoing maintenance hemodialysis (HD) affected by COVID-19, evaluating the potential modulating effects of two different dialysis approaches
Read the detailed description
For this prospective randomized study, the investigators recruit maintenance hemodialysis patients with confirmed COVID-19 infection. After diagnosis, the patients are randomized to two different dialysis modalities, expanded HD (HDx), performed by use of a medium cut-off membrane, and standard treatment based on the use of a protein-leaking dialyzer (PLD).
The investigators collect clinical and laboratory data, including circulating pre and post-dialysis levels of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TLR4 (sTLR4), and interferon-gamma (IFN-g). Samples are collected at diagnosis (T0), and one and two weeks after the diagnosis (T7 and T14, respectively). Moreover, lymphocyte and immune cell profiles are evaluated.
- Conditions
- Covid19, Hemodialysis Complication, Inflammatory Response
- Being tested
- Expanded Hemodialysis for Covid19 maintenance hemodialysis patients, Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients
- Keywords
- Hemodialysis, Covid19, Inflammation
- Medical subject headings
- COVID-19, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded Hemodialysis for Covid19 maintenance hemodialysis patientsProcedure or surgery
After Covid19 diagnosis participants are randomized to receive Expanded Hemodialysis for two weeks
Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patientsProcedure or surgery
After Covid19 diagnosis participants are randomized to receive hemodialysis by protein-leaking dialyzer for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Expanded Hemodialysis | Experimental | Hemodialysis modality performed by using a medium cut-off membrane Receives: Procedure: Expanded Hemodialysis for Covid19 maintenance hemodialysis patients |
| Protein-leaking hemodialysis | Experimental | Hemodialysis modality performed by using a membrane with accentuated absorption capacities. Receives: Procedure: Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal changes of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and interferon-gamma (IFN-γ) plasma levels during Covid19 in hemodialysis patients
Evaluation of circulating levels of pro and anti-inflammatory cytokines (pg/ml) at different time-points in patients treated with two different dialysis modalities
Measured: Two-week observation period after Covid19 diagnosis
Longitudinal changes of soluble TLR4 (sTLR4) plasma levels during Covid19 in hemodialysis patients
Evaluation of circulating levels of soluble TLR4 (sTLR4, ng/ml)at different time-points in patients treated with two different dialysis modalities
Measured: Two-week observation period after Covid19 diagnosis
Secondary outcomes (1)
Longitudinal changes of cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), cluster of differentiation 19 (CD19), natural killer (NK) lymphocyte count and function during Covid19 in hemodialysis patients
Lymphocyte and immune cell profiles studied by flow cytometry
Measured: Two-week observation period after Covid19 diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start16 Mar 2020
- Primary completion20 Apr 2020
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Responsible party
- Principal investigator, Pasquale Esposito, Universita degli Studi di Genova
- Investigators
- Francesca Viazzi, MD, Study director, Unit of Nephrology, Dept Internal Medicine, Univerity of Genova and San Martino Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685447
- Sponsor's protocol ID
- CER Liguria: 135/20
- Status last verified
- May 2022
- First submitted
- 22 Dec 2020
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Esposito P, Russo R, Conti N, Falqui V, Massarino F, Moriero E, Peloso G, Traverso GB, Garibotto G, Viazzi F. Management of COVID-19 in hemodialysis patients: The Genoa experience. Hemodial Int. 2020 Jul;24(3):423-427. doi: 10.1111/hdi.12837. Epub 2020 May 12. No abstract available.
PubMed 32365278Russo E, Esposito P, Taramasso L, Magnasco L, Saio M, Briano F, Russo C, Dettori S, Vena A, Di Biagio A, Garibotto G, Bassetti M, Viazzi F; GECOVID working group. Kidney disease and all-cause mortality in patients with COVID-19 hospitalized in Genoa, Northern Italy. J Nephrol. 2021 Feb;34(1):173-183. doi: 10.1007/s40620-020-00875-1. Epub 2020 Oct 6.
PubMed 33025516Ma Y, Diao B, Lv X, Zhu J, Chen C, Liu L, Zhang S, Shen B, Wang H. Epidemiological, Clinical, and Immunological Features of a Cluster of COVID-19-Contracted Hemodialysis Patients. Kidney Int Rep. 2020 Jun 9;5(8):1333-1341. doi: 10.1016/j.ekir.2020.06.003. eCollection 2020 Aug.
PubMed 32775837
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Cytokine Profile in Maintenance Hemodialysis Patients Affected by COVID-19: Effects of 2 Different Dialysis Strategies
- ClinicalTrials.gov ID
- NCT04685447
- Acronym / sponsor ID
- CER Liguria: 135/20
- Conditions
- Covid19, Hemodialysis Complication, Inflammatory Response
- Keywords
- Hemodialysis, Covid19, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 28 Dec 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.
In the course of Coronavirus Disease-19 (COVID-19) uncontrolled inflammation has been related to disease severity and unfavorable outcomes.
Here, the investigators study the longitudinal changes of pro- and anti-inflammatory markers in a population of patients undergoing maintenance hemodialysis (HD) affected by COVID-19, evaluating the potential modulating effects of two different dialysis approaches
Detailed description
For this prospective randomized study, the investigators recruit maintenance hemodialysis patients with confirmed COVID-19 infection. After diagnosis, the patients are randomized to two different dialysis modalities, expanded HD (HDx), performed by use of a medium cut-off membrane, and standard treatment based on the use of a protein-leaking dialyzer (PLD).
The investigators collect clinical and laboratory data, including circulating pre and post-dialysis levels of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TLR4 (sTLR4), and interferon-gamma (IFN-g). Samples are collected at diagnosis (T0), and one and two weeks after the diagnosis (T7 and T14, respectively). Moreover, lymphocyte and immune cell profiles are evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expanded Hemodialysis | Experimental | Procedure: Expanded Hemodialysis for Covid19 maintenance hemodialysis patientsHemodialysis modality performed by using a medium cut-off membrane |
| Protein-leaking hemodialysis | Experimental | Procedure: Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patientsHemodialysis modality performed by using a membrane with accentuated absorption capacities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing maintenance hemodialysis
- Confirmed severe acute respiratory syndrome-coronavirus2 infection
Key exclusion criteria (1 listed)
- Acute kidney injury
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 |
|---|---|---|
| Expanded Hemodialysis for Covid19 maintenance hemodialysis patientsAfter Covid19 diagnosis participants are randomized to receive Expanded Hemodialysis for two weeks | Procedure or surgery | Expanded Hemodialysis |
| Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patientsAfter Covid19 diagnosis participants are randomized to receive hemodialysis by protein-leaking dialyzer for two weeks | Procedure or surgery | Protein-leaking hemodialysis |
Primary outcome
Longitudinal changes of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and interferon-gamma (IFN-γ) plasma levels during Covid19 in hemodialysis patients
Time frame: Two-week observation period after Covid19 diagnosis
Evaluation of circulating levels of pro and anti-inflammatory cytokines (pg/ml) at different time-points in patients treated with two different dialysis modalities
Longitudinal changes of soluble TLR4 (sTLR4) plasma levels during Covid19 in hemodialysis patients
Time frame: Two-week observation period after Covid19 diagnosis
Evaluation of circulating levels of soluble TLR4 (sTLR4, ng/ml)at different time-points in patients treated with two different dialysis modalities
1 secondary outcome
Longitudinal changes of cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), cluster of differentiation 19 (CD19), natural killer (NK) lymphocyte count and function during Covid19 in hemodialysis patients
Time frame: Two-week observation period after Covid19 diagnosis
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 17 May 2022.
- Background: PubMed 32365278Esposito P, Russo R, Conti N, Falqui V, Massarino F, Moriero E, Peloso G, Traverso GB, Garibotto G, Viazzi F. Management of COVID-19 in hemodialysis patients: The Genoa experience. Hemodial Int. 2020 Jul;24(3):423-427. doi: 10.1111/hdi.12837. Epub 2020 May 12. No abstract available.
- Background: PubMed 33025516Russo E, Esposito P, Taramasso L, Magnasco L, Saio M, Briano F, Russo C, Dettori S, Vena A, Di Biagio A, Garibotto G, Bassetti M, Viazzi F; GECOVID working group. Kidney disease and all-cause mortality in patients with COVID-19 hospitalized in Genoa, Northern Italy. J Nephrol. 2021 Feb;34(1):173-183. doi: 10.1007/s40620-020-00875-1. Epub 2020 Oct 6.
- Background: PubMed 32775837Ma Y, Diao B, Lv X, Zhu J, Chen C, Liu L, Zhang S, Shen B, Wang H. Epidemiological, Clinical, and Immunological Features of a Cluster of COVID-19-Contracted Hemodialysis Patients. Kidney Int Rep. 2020 Jun 9;5(8):1333-1341. doi: 10.1016/j.ekir.2020.06.003. eCollection 2020 Aug.
- Individual participant dataSharing planned: No
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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.
Francesca Viazzi, MD study director
Unit of Nephrology, Dept Internal Medicine, Univerity of Genova and San Martino Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded Hemodialysis for Covid19 maintenance hemodialysis patients and Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients in people with Covid19 and Hemodialysis Complication, run by Universita degli Studi di Genova at 2 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 1 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 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Longitudinal changes of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and interferon-gamma (IFN-γ) plasma levels during Covid19 in hemodialysis patients (time frame: Two-week observation period after Covid19 diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04685447, which also lists 3 linked publications.
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 17 May 2022.