SARS-CoV-2 InfectionDial-COVIDNCT05040737
PMMA vs Polysulfone in SARS-CoV-2 Infection Hemodialysis Patients
A study testing PS membrane versus PMMA membrane, in people with SARS-CoV-2 Infection, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- PS membrane versus PMMA membrane,
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 17 Apr 2020to 31 Dec 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years .
- Patient on chronic haemodialysis admitted to the hospital with a diagnosis of infection by COVID-19.
- Signature of informed consent or legal representative.
- Estimated duration of admission greater than 8 days (4 haemodialysis sessions).
- Patient with haemodynamic stability, understood as systolic blood pressure ≥ 100 mmHg.
Who cannot join
- Refusal to sign the consent form.
- Patients who for clinical reasons are unable to follow a regular dialysis schedule of three sessions per week.
- Allergy (documented or suspected) to either of the two membranes involved in the study.
- Patient with haemodynamic instability (Mean arterial pressure < 100 mmHg).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Types of Dialyzers (PMMA vs Polysulfone) on Cytokine Extraction in Hemodialysis Patients and COVID Infection. A Multicenter Prospective Study
Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19.
Read the detailed description
Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19.
Patients will be dialysed according to the usual dialysis schedule of three weekly sessions. The study has a duration of 8 days in order to include 4 haemodialysis sessions. The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- PS membrane versus PMMA membrane,
- Keywords
- Haemodialysis, SARS-CoV-2 Infection, cytokines
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS membrane versus PMMA membrane,Device
Patients will be dialysed according to the usual dialysis schedule of three weekly sessions. The study has a duration of 8 days in order to include 4 haemodialysis sessions. The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Patients will be dialysed according to the usual dialysis schedule of three weekly sessions. The study has a duration of 8 days in order to include 4 haemodialysis sessions. The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2. Receives: Device: PS membrane versus PMMA membrane, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS).
To compare the percentage reduction of inflammatory interleukins measured at the beginning and end of haemodialysis in the same patient with COVID 19 infection dialysed with two different dialysis membranes (PMMA and PS).
Measured: Day 8
Secondary outcomes (3)
Percentage of Inflammatory interleukins reduction
Inflammatory interleukins reduction maintenance with each membrane after a second dialysis
Measured: Days 5 and 8
Inflammatory interleukins reduction (30 minutes)
Inflammatory interleukins percentage reduction 30 min after each session,
Measured: Days 1,3,5,8
Populational characteristics
To describe the characteristics of haemodialysis population affected by COVID -19
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start17 Apr 2020
- Primary completion8 Feb 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª Jesús Puchades, Fundación para la Investigación del Hospital Clínico de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040737
- Sponsor's protocol ID
- Dial-COVID
- Acronym
- Dial-COVID
- Status last verified
- Sep 2021
- First submitted
- 1 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Types of Dialyzers (PMMA vs Polysulfone) on Cytokine Extraction in Hemodialysis Patients and COVID Infection. A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT05040737
- Acronym / sponsor ID
- Dial-COVID / Dial-COVID
- Conditions
- SARS-CoV-2 Infection
- Keywords
- Haemodialysis, SARS-CoV-2 Infection, cytokines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Sep 2021 (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.
Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19.
Detailed description
Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19.
Patients will be dialysed according to the usual dialysis schedule of three weekly sessions. The study has a duration of 8 days in order to include 4 haemodialysis sessions. The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Device: PS membrane versus PMMA membrane,Patients will be dialysed according to the usual dialysis schedule of three weekly sessions. The study has a duration of 8 days in order to include 4 haemodialysis sessions. The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years .
- Patient on chronic haemodialysis admitted to the hospital with a diagnosis of infection by COVID-19.
- Signature of informed consent or legal representative.
- Estimated duration of admission greater than 8 days (4 haemodialysis sessions).
- Patient with haemodynamic stability, understood as systolic blood pressure ≥ 100 mmHg.
Key exclusion criteria (4 listed)
- Refusal to sign the consent form.
- Patients who for clinical reasons are unable to follow a regular dialysis schedule of three sessions per week.
- Allergy (documented or suspected) to either of the two membranes involved in the study.
- Patient with haemodynamic instability (Mean arterial pressure < 100 mmHg).
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 |
|---|---|---|
| PS membrane versus PMMA membrane,Patients will be dialysed according to the usual dialysis schedule of three weekly sessions. The study has a duration of 8 days in order to include 4 haemodialysis sessions. The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2. | Device | Study Arm |
Primary outcome
Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS).
Time frame: Day 8
To compare the percentage reduction of inflammatory interleukins measured at the beginning and end of haemodialysis in the same patient with COVID 19 infection dialysed with two different dialysis membranes (PMMA and PS).
3 secondary outcomes
Percentage of Inflammatory interleukins reduction
Time frame: Days 5 and 8
Inflammatory interleukins reduction (30 minutes)
Time frame: Days 1,3,5,8
Populational characteristics
Time frame: Day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS membrane versus PMMA membrane, in people with SARS-CoV-2 Infection, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
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?
Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS). (time frame: Day 8). 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 10 Sep 2021.