Dialysis; ComplicationsIMMUNOVIDIALNCT05307601
Immune Response Following COVID-19 in Hemodialysis Patients
An observational study of Dialysis; Complications and COVID-19, run by AURA Paris at 1 site in France.
Trial summary
Patients with chronic kidney disease (CKD), particularly those undergoing hemodialysis (HD), are at high risk of a severe form of COVID-19. This study aims to characterize the inflammatory and antiviral response during SarsCov2 infection in adult Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis; Complications, COVID-19, Cytokine Storm
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 30 Oct 2021
- 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: Adult HD patients from 2 main dialysis units of the AURA: AURA Paris Plaisance and Saint-Ouen
Who may be able to join
- Adult (>18 years old) patient on HD > 6 months, and
- Infection by SARS-CoV-2. Diagnosis of COVID-19 was assessed by Reverse-Transcriptase-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2 in nasopharyngeal swab or by typical COVID-19 radiological images on thoracic computerized tomography (CT scan). The date of diagnosis was defined as the day when RT-PCR or CT-scan confirmed the diagnosis.
Who cannot join
- Inability to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Cytokine 's Profile Following SarsCov 2 Infection (COVID-19) in Hemodialysis Patients
Patients with chronic kidney disease (CKD), particularly those undergoing hemodialysis (HD), are at high risk of a severe form of COVID-19.
This study aims to characterize the inflammatory and antiviral response during SarsCov2 infection in adult
Read the detailed description
Inclusion criteria were (1) Adult (>18 years old) patient on HD > 6 months, and (2) infection by SARS-CoV-2. Diagnosis of COVID-19 was assessed by Reverse-Transcriptase-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2 in nasopharyngeal swab or by typical COVID-19 radiological images on thoracic computerized tomography (CT scan).
Severe forms of COVID-19 were defined as requiring oxygen therapy, admission in intensive care unit (ICU) or death
Primary end point :
- Characterization the cytokine's profile at the early (day 7) and inflammatory (day 14) phase of COViD-19 in HD patient
Secondary End points :
- Analyse the kinetic of the antiviral response (type I and III interferon ) between the early (day 7) and inflammatory (day 14) phase of COViD-19.
- Analyse the kinetic of proinflammatory cytokine response between the early (day 7) and inflammatory (day 14) phase of COViD-19.
- Define an antiviral signature associated with severe form of COVID-19
- Define an anti inflammatory signature associated with severe form of COVID-19
Cytokine's profile is define by the measure of 28 cytokines by Luminex technology
- Conditions
- Dialysis; Complications, COVID-19, Cytokine Storm
- Keywords
- dialysis, cytokine, COVID-19
- Medical subject headings
- COVID-19, Cytokine Release Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the cytokine profile during the early phase of COVID-19
Measurement of 29 cytokines by Luminex including type I and Type III Interferon
Measured: Measurement at Day 7 of COVID-19
Characterization of the cytokine profile during the inflammatory phase of COVID-19
Measurement of 29 cytokines by Luminex including type I and Type III Interferon
Measured: Measurement at Day 14 of COVID-19]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dialysis; ComplicationsStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AURA Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Touzot, MD, PhD, Principal investigator, AURA Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307601
- Sponsor's protocol ID
- 2020-A01426-33
- Acronym
- IMMUNOVIDIAL
- Status last verified
- Mar 2022
- First submitted
- 24 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mutinelli-Szymanski P, Hude I, Merle E, Lombardi Y, Seris P, Abtahi M, Azeroual L, Bourgain C, Ensergueix G, Katerinis I, Kolko A, Kolta A, Maheas C, Mehrbanian S, Morel P, Ossman R, de Preneuf H, Roux A, Saltiel C, Vende F, Verhoeven AS, Viron B, Laplanche S, Le Monnier A, Ridel C, Urena-Torres P, Touzot M. Neutrophil:lymphocyte ratio predicts short-term outcome of COVID-19 in haemodialysis patients. Clin Kidney J. 2020 Nov 21;14(1):124-131. doi: 10.1093/ckj/sfaa194. eCollection 2021 Jan.
PubMed 33558835Pedersen SF, Ho YC. SARS-CoV-2: a storm is raging. J Clin Invest. 2020 May 1;130(5):2202-2205. doi: 10.1172/JCI137647.
PubMed 32217834Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B. Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1526-33. doi: 10.2215/CJN.00950208. Epub 2008 Aug 13.
PubMed 18701615Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.
PubMed 32217835
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cytokine 's Profile Following SarsCov 2 Infection (COVID-19) in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05307601
- Acronym / sponsor ID
- IMMUNOVIDIAL / 2020-A01426-33
- Conditions
- Dialysis; Complications, COVID-19, Cytokine Storm
- Keywords
- dialysis, cytokine, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AURA ParisUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 1 Apr 2022 (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 with chronic kidney disease (CKD), particularly those undergoing hemodialysis (HD), are at high risk of a severe form of COVID-19.
This study aims to characterize the inflammatory and antiviral response during SarsCov2 infection in adult
Detailed description
Inclusion criteria were (1) Adult (>18 years old) patient on HD > 6 months, and (2) infection by SARS-CoV-2. Diagnosis of COVID-19 was assessed by Reverse-Transcriptase-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2 in nasopharyngeal swab or by typical COVID-19 radiological images on thoracic computerized tomography (CT scan).
Severe forms of COVID-19 were defined as requiring oxygen therapy, admission in intensive care unit (ICU) or death
Primary end point :
- Characterization the cytokine's profile at the early (day 7) and inflammatory (day 14) phase of COViD-19 in HD patient
Secondary End points :
- Analyse the kinetic of the antiviral response (type I and III interferon ) between the early (day 7) and inflammatory (day 14) phase of COViD-19.
- Analyse the kinetic of proinflammatory cytokine response between the early (day 7) and inflammatory (day 14) phase of COViD-19.
- Define an antiviral signature associated with severe form of COVID-19
- Define an anti inflammatory signature associated with severe form of COVID-19
Cytokine's profile is define by the measure of 28 cytokines by Luminex technology
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult HD patients from 2 main dialysis units of the AURA: AURA Paris Plaisance and Saint-Ouen
Key inclusion criteria (2 listed)
- Adult (>18 years old) patient on HD > 6 months, and
- Infection by SARS-CoV-2. Diagnosis of COVID-19 was assessed by Reverse-Transcriptase-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2 in nasopharyngeal swab or by typical COVID-19 radiological images on thoracic computerized tomography (CT scan). The date of diagnosis was defined as the day when RT-PCR or CT-scan confirmed the diagnosis.
Key exclusion criteria (1 listed)
- Inability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of the cytokine profile during the early phase of COVID-19
Time frame: Measurement at Day 7 of COVID-19
Measurement of 29 cytokines by Luminex including type I and Type III Interferon
Characterization of the cytokine profile during the inflammatory phase of COVID-19
Time frame: Measurement at Day 14 of COVID-19]
Measurement of 29 cytokines by Luminex including type I and Type III Interferon
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 1 Apr 2022.
- Background: PubMed 33558835Mutinelli-Szymanski P, Hude I, Merle E, Lombardi Y, Seris P, Abtahi M, Azeroual L, Bourgain C, Ensergueix G, Katerinis I, Kolko A, Kolta A, Maheas C, Mehrbanian S, Morel P, Ossman R, de Preneuf H, Roux A, Saltiel C, Vende F, Verhoeven AS, Viron B, Laplanche S, Le Monnier A, Ridel C, Urena-Torres P, Touzot M. Neutrophil:lymphocyte ratio predicts short-term outcome of COVID-19 in haemodialysis patients. Clin Kidney J. 2020 Nov 21;14(1):124-131. doi: 10.1093/ckj/sfaa194. eCollection 2021 Jan.
- Background: PubMed 32217834Pedersen SF, Ho YC. SARS-CoV-2: a storm is raging. J Clin Invest. 2020 May 1;130(5):2202-2205. doi: 10.1172/JCI137647.
- Background: PubMed 18701615Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B. Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1526-33. doi: 10.2215/CJN.00950208. Epub 2008 Aug 13.
- Background: PubMed 32217835Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.
- 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.
Maxime Touzot, MD, PhD principal investigator
AURA Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis; Complications and COVID-19, run by AURA Paris at 1 site in France.
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 1 Apr 2022. 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 France. 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?
Characterization of the cytokine profile during the early phase of COVID-19 (time frame: Measurement at Day 7 of COVID-19). 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 NCT05307601, which also lists 4 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 1 Apr 2022.