Coronavirus InfectionCYCOV-IINCT04385771
Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation
A study testing vv-ECMO + cytokine adsorption (Cytosorb adsorber) and vv-ECMO only (no cytokine adsorption) in people with Coronavirus Infection and COVID, run by Dr. Alexander Supady at 3 sites in Germany.
Trial summary
In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronavirus Infection, COVID, SARS-CoV 2
- What is being tested?
- vv-ECMO + cytokine adsorption (Cytosorb adsorber) and vv-ECMO only (no cytokine adsorption)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Sep 2020to 31 Oct 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SARS-CoV-2-infection with COVID-pneumonia
- vv-ECMO therapy
Who cannot join
- known patient will against participation in the study or against the measures applied in the study
- a decision (made prior to inclusion of the patient into this trial) to terminate the treatment within the next 24 hours
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Clinic Freiburg
Freiburg im Breisgau, 79106
Klinikum Ibbenbueren
Ibbenbueren, 49477
Klinikum Ludwigsburg
Ludwigsburg
About this study
Official title: Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation - Randomized, Controlled, Open-label Intervention, Multi-center Trial (CYCOV-II-study)
In December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world.
Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen.
Read more
Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome.
From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients.
The aim of the study is to investigate the influence of extracorporeal cytokine adsorption on interleukin-6-levels and time to successful ECMO explantation under controlled conditions in patients with particularly severe COVID-19 disease requiring extracorporeal membrane oxygenation.
Read the detailed description
In December 2019, a series of unexplained cases of pneumonia in the city of Wuhan in China has come to light. In virologic analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (first named 2019-nCoV, then SARS-CoV-2). The disease spread rapidly in the city of Wuhan in early 2020 and soon beyond. On 30 January 2020, the Director-General of the World Health Organization (WHO) declared the outbreak a public health emergency of international concern, and on 11 March 2020, the World Health Organization declared the virus a pandemic.
In humans, an infection with the virus can cause respiratory tract infections or even very severe pneumonia - these often end fatally, especially in old and pre-diseased patients. Due to the novelty of the virus, the data basis for therapy is very limited. To date, there are no clinical data for an effective specific therapy, nor is there a vaccination against the virus available, so that therapy, especially intensive care treatment for very severe courses, must concentrate only on supportive treatment of lung failure and other complications.
The virus is highly contagious and infection results in a relevant number of deaths. Due to very uncertain data on the spread of the virus in the population, it is difficult to estimate the mortality rate - the case fatality rate is about 4% based on the known case numbers.
In reports on the treatment of the first cases in Wuhan (Hubei Province, China) in January 2020, the need for intensive care treatment is described for about a quarter of the inpatient cases, 10-17% had to be ventilated invasively, and veno-venous extracorporeal membrane oxygenation (vv-ECMO) was necessary in 2-4% of the inpatient cases. Patients requiring ECMO have an extremely high mortality rate of 83-100% in the studies published, so far.
In severe cases a pronounced release of vasoactive cytokines was repeatedly observed. Excessive release of these vasoactive mediators ("cytokine storm") can result in severe vasodilatation and membrane leakage, which can ultimately lead to vasoplegic shock that is difficult to control. Ruan et al. and Zhou et al. have identified high interleukin 6 (IL-6) levels as a potential predictor of a fatal outcome when compared between survivors and patients who died of COVID-19 disease.
IL-6 is also an important factor in the pathophysiology of severe septic shock and excessive immune response in hemophagocytic lymphohistiocytosis (HLH) - for both indications has been shown, that the extracorporeal adsorption of IL-6 and other vasoactive substances in a CytoSorb® adsorber (CytoSorbents Corporation, Monmouth Junction, NJ, USA) leads to a significant reduction of these cytokines in the patient blood. Clinical experience and (previously unpublished) data from our monocentric registry study show that cytokine adsorption in a CytoSorb® Adsorber can also be safely integrated into a vv-ECMO system.
- Conditions
- Coronavirus Infection, COVID, SARS-CoV 2, Respiratory Failure, Cytokine Storm, Extracorporeal Membrane Oxygenation
- Being tested
- vv-ECMO + cytokine adsorption (Cytosorb adsorber), vv-ECMO only (no cytokine adsorption)
- Keywords
- COVID-19, ECMO, ARDS, Cytokine Adsorption
- Medical subject headings
- Coronavirus Infections, Respiratory Insufficiency, Cytokine Release Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vv-ECMO + cytokine adsorption (Cytosorb adsorber)Device
in COVID-19-diseased vv-ECMO patients additional treatment with cytokine adsorption using a Cytosorb adsorber will be randomized (vs. control group)
vv-ECMO only (no cytokine adsorption)Device
COVID-19-diseased treated with vv-ECMO
| Study group | Role | What they receive |
|---|---|---|
| vv-ECMO + cytokine adsorption | Experimental | after indication of treatment with vv-ECMO in acute respiratory failure in COVID-19-disease, patients will additionally receive cytokine adsorption using a Cytosorb adsorber Receives: Device: vv-ECMO + cytokine adsorption (Cytosorb adsorber) |
| vv-ECMO (no cytokine adsorption) | Other | treatment with vv-ECMO in acute respiratory failure in COVID-19-disease (standard treatment without additional cytokine adsorption) Receives: Device: vv-ECMO only (no cytokine adsorption) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 reduction by 75% or more after 72 hours as compared to the baseline measurement
measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)
Measured: 72 hours
time to successful ECMO-explantation
time to successful ECMO-explantation within 30 days after randomization
Measured: 30 days
Secondary outcomes (16)
Ventilator free days (VFD)
Ventilator free days (VFD) in the first 30 days after randomization, where invasive mechanical ventilation (IMV), non-invasive ventilation (NIV) and ECMO are defined as ventilator days. VFD=0, if the patient dies in the first 30 days after randomization
Measured: 30 days
Time to extubation from ventilation and explantation from ECMO
Time to extubation from ventilation and explantation from ECMO. Death under ventilation and/or ECMO will be analyzed as a competing event. The time will be censored at the time of last visit for surviving patients under ventilation and/or ECMO.
Measured: 30 days
Overall survival time
Overall survival time, defined as time from randomization to death. The time will be censored at the time of last visit for surviving patients.
Measured: 30 days
Days on intensive care unit (ICU)
Days on intensive care unit (ICU)
Measured: 30 days
Vasopressor dosage
Vasopressor dosage of adrenaline, noradrenaline, vasopressin, and dobutamine at 24, 48,72 h
Measured: 24, 48, 72 hours
Fluid substitution and fluid balance
Total fluid[ml] substitution and fluid balance [ml] at 24, 48, 72 h
Measured: 24, 48, 72 hours
Serum lactate
Serum lactate at 24, 48, 72 h
Measured: 24, 48, 72 hours
Urine output
Urine output at 24, 48, 72 h
Measured: 24, 48, 72 hours
Willebrand factor
Willebrand factor at 24, 48, 72 h
Measured: 24, 48, 72 hours
d-dimers
d-dimers at 24, 48, 72 h
Measured: 24, 48, 72 hours
interleukin-6 levels
interleukin-6 levels at 24, 48, 72 h
Measured: 24, 48, 72 hours
SOFA-Score
Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)
Measured: 24, 48, 72 hours
serious adverse device effects
serious complications or malfunctions related to the CytoSorb device
Measured: 30 days
adverse event of special interest: air in the ECMO system
unintended air in the ECMO system during operation of the device
Measured: 30 days
adverse event of special interest: blood-clotting in the ECMO system
unintended blood-clotting in the ECMO system during operation of the device
Measured: 30 days
adverse event of special interest: bleeding complications
major bleeding events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Sep 2020
- Primary completion31 May 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Why it stopped: security concerns based on preliminary results from preceding CYCOV-I-study suggesting higer mortality in cytokine adsorption group
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 Coronavirus 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial examining COVID-patients requiring vv-ECMO therapy (+/- cytokine adsorption)
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Alexander Supady
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Ibbenbüren, Ludwig-Maximilians - University of Munich, University Hospital, Saarland, Klinikum Ludwigsburg, University of Ulm, SLK Kliniken Heilbronn GmbH, Martin-Luther-Universität Halle-Wittenberg
- Responsible party
- Sponsor-investigator, Dr. Alexander Supady, University Hospital Freiburg
- Investigators
- Alexander Supady, Dr., MPH, Principal investigator, University Clinic Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385771
- Sponsor's protocol ID
- CYCOV-II
- Acronym
- CYCOV-II
- Status last verified
- Mar 2021
- First submitted
- 19 Apr 2020
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shekar K, McAuley DF, Brodie D. Cytokine adsorption during ECMO for COVID-19-related ARDS. Lancet Respir Med. 2021 Jul;9(7):680-682. doi: 10.1016/S2213-2600(21)00207-1. Epub 2021 May 14. No abstract available.
PubMed 34000235Rieder M, Duerschmied D, Zahn T, Lang C, Benk C, Lother A, Biever P, Bode C, Wengenmayer T, Staudacher D, Supady A. Cytokine Adsorption in Severe Acute Respiratory Failure Requiring Veno-Venous Extracorporeal Membrane Oxygenation. ASAIO J. 2021 Mar 1;67(3):332-338. doi: 10.1097/MAT.0000000000001302.
PubMed 33627609Rieder M, Schubach F, Schmoor C, von Spee-Mayer C, Wengenmayer T, Rilinger J, Staudacher D, Bode C, Duerschmied D, Supady A. Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation: protocol for a randomised, controlled, open-label intervention, multicentre trial. BMJ Open. 2021 Jan 17;11(1):e043345. doi: 10.1136/bmjopen-2020-043345.
PubMed 33455938
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation - Randomized, Controlled, Open-label Intervention, Multi-center Trial (CYCOV-II-study)
- ClinicalTrials.gov ID
- NCT04385771
- Acronym / sponsor ID
- CYCOV-II / CYCOV-II
- Conditions
- Coronavirus Infection, COVID, SARS-CoV 2, Respiratory Failure, Cytokine Storm, Extracorporeal Membrane Oxygenation
- Keywords
- COVID-19, ECMO, ARDS, Cytokine Adsorption
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: security concerns based on preliminary results from preceding CYCOV-I-study suggesting higer mortality in cytokine adsorption group
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr. Alexander SupadyUniversity, hospital or other
- Collaborators
- Klinikum Ibbenbüren, Ludwig-Maximilians - University of Munich, University Hospital, Saarland, Klinikum Ludwigsburg, University of Ulm, SLK Kliniken Heilbronn GmbH, Martin-Luther-Universität Halle-Wittenberg
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 13 May 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 December 2019 in the city of Wuhan in China, a series of patients with unclear pneumonia was noticed, some of whom have died of it. In virological analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (SARS-CoV-2). The disease spread rapidly in the city of Wuhan at the beginning of 2020 and soon beyond in China and, in the coming weeks, around the world.
Initial studies described numerous severe courses, particularly those associated with increased patient age and previous cardiovascular, metabolic and respiratory diseases. A small number of the particularly severely ill patients required not only highly invasive ventilation therapy but also extracorporeal membrane oxygenation (vv-ECMO) to supply the patient's blood with sufficient oxygen.
Even under maximum intensive care treatment, a very high mortality rate of approximately 80-100% was observed in this patient group. In addition, high levels of interleukin-6 (IL-6) could be detected in the blood of these severely ill patients, which in turn were associated with poor outcome.
From experience in the therapy of severely ill patients with severe infections and respiratory failure, we know that treatment with a CytoSorb® adsorber can lead to a reduction of the circulating pro- and anti-inflammatory cytokines and thus improve the course of the disease and the outcome of the patients.
The aim of the study is to investigate the influence of extracorporeal cytokine adsorption on interleukin-6-levels and time to successful ECMO explantation under controlled conditions in patients with particularly severe COVID-19 disease requiring extracorporeal membrane oxygenation.
Detailed description
In December 2019, a series of unexplained cases of pneumonia in the city of Wuhan in China has come to light. In virologic analyses of samples from the patients' deep respiratory tract, a novel coronavirus was isolated (first named 2019-nCoV, then SARS-CoV-2). The disease spread rapidly in the city of Wuhan in early 2020 and soon beyond. On 30 January 2020, the Director-General of the World Health Organization (WHO) declared the outbreak a public health emergency of international concern, and on 11 March 2020, the World Health Organization declared the virus a pandemic.
In humans, an infection with the virus can cause respiratory tract infections or even very severe pneumonia - these often end fatally, especially in old and pre-diseased patients. Due to the novelty of the virus, the data basis for therapy is very limited. To date, there are no clinical data for an effective specific therapy, nor is there a vaccination against the virus available, so that therapy, especially intensive care treatment for very severe courses, must concentrate only on supportive treatment of lung failure and other complications.
The virus is highly contagious and infection results in a relevant number of deaths. Due to very uncertain data on the spread of the virus in the population, it is difficult to estimate the mortality rate - the case fatality rate is about 4% based on the known case numbers.
In reports on the treatment of the first cases in Wuhan (Hubei Province, China) in January 2020, the need for intensive care treatment is described for about a quarter of the inpatient cases, 10-17% had to be ventilated invasively, and veno-venous extracorporeal membrane oxygenation (vv-ECMO) was necessary in 2-4% of the inpatient cases. Patients requiring ECMO have an extremely high mortality rate of 83-100% in the studies published, so far.
In severe cases a pronounced release of vasoactive cytokines was repeatedly observed. Excessive release of these vasoactive mediators ("cytokine storm") can result in severe vasodilatation and membrane leakage, which can ultimately lead to vasoplegic shock that is difficult to control. Ruan et al. and Zhou et al. have identified high interleukin 6 (IL-6) levels as a potential predictor of a fatal outcome when compared between survivors and patients who died of COVID-19 disease.
IL-6 is also an important factor in the pathophysiology of severe septic shock and excessive immune response in hemophagocytic lymphohistiocytosis (HLH) - for both indications has been shown, that the extracorporeal adsorption of IL-6 and other vasoactive substances in a CytoSorb® adsorber (CytoSorbents Corporation, Monmouth Junction, NJ, USA) leads to a significant reduction of these cytokines in the patient blood. Clinical experience and (previously unpublished) data from our monocentric registry study show that cytokine adsorption in a CytoSorb® Adsorber can also be safely integrated into a vv-ECMO system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial examining COVID-patients requiring vv-ECMO therapy (+/- cytokine adsorption)
| Arm | Type | Receives |
|---|---|---|
| vv-ECMO + cytokine adsorption | Experimental | Device: vv-ECMO + cytokine adsorption (Cytosorb adsorber)after indication of treatment with vv-ECMO in acute respiratory failure in COVID-19-disease, patients will additionally receive cytokine adsorption using a Cytosorb adsorber |
| vv-ECMO (no cytokine adsorption) | Other | Device: vv-ECMO only (no cytokine adsorption)treatment with vv-ECMO in acute respiratory failure in COVID-19-disease (standard treatment without additional cytokine adsorption) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- SARS-CoV-2-infection with COVID-pneumonia
- vv-ECMO therapy
Key exclusion criteria (2 listed)
- known patient will against participation in the study or against the measures applied in the study
- a decision (made prior to inclusion of the patient into this trial) to terminate the treatment within the next 24 hours
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 |
|---|---|---|
| vv-ECMO + cytokine adsorption (Cytosorb adsorber)in COVID-19-diseased vv-ECMO patients additional treatment with cytokine adsorption using a Cytosorb adsorber will be randomized (vs. control group) | Device | vv-ECMO + cytokine adsorption |
| vv-ECMO only (no cytokine adsorption)COVID-19-diseased treated with vv-ECMO | Device | vv-ECMO (no cytokine adsorption) |
Primary outcome
IL-6 reduction by 75% or more after 72 hours as compared to the baseline measurement
Time frame: 72 hours
measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)
time to successful ECMO-explantation
Time frame: 30 days
time to successful ECMO-explantation within 30 days after randomization
16 secondary outcomes
Ventilator free days (VFD)
Time frame: 30 days
Time to extubation from ventilation and explantation from ECMO
Time frame: 30 days
Overall survival time
Time frame: 30 days
Days on intensive care unit (ICU)
Time frame: 30 days
Vasopressor dosage
Time frame: 24, 48, 72 hours
Fluid substitution and fluid balance
Time frame: 24, 48, 72 hours
Serum lactate
Time frame: 24, 48, 72 hours
Urine output
Time frame: 24, 48, 72 hours
Willebrand factor
Time frame: 24, 48, 72 hours
d-dimers
Time frame: 24, 48, 72 hours
interleukin-6 levels
Time frame: 24, 48, 72 hours
SOFA-Score
Time frame: 24, 48, 72 hours
serious adverse device effects
Time frame: 30 days
adverse event of special interest: air in the ECMO system
Time frame: 30 days
adverse event of special interest: blood-clotting in the ECMO system
Time frame: 30 days
adverse event of special interest: bleeding complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Derived from this study: PubMed 34000235Shekar K, McAuley DF, Brodie D. Cytokine adsorption during ECMO for COVID-19-related ARDS. Lancet Respir Med. 2021 Jul;9(7):680-682. doi: 10.1016/S2213-2600(21)00207-1. Epub 2021 May 14. No abstract available.
- Derived from this study: PubMed 33627609Rieder M, Duerschmied D, Zahn T, Lang C, Benk C, Lother A, Biever P, Bode C, Wengenmayer T, Staudacher D, Supady A. Cytokine Adsorption in Severe Acute Respiratory Failure Requiring Veno-Venous Extracorporeal Membrane Oxygenation. ASAIO J. 2021 Mar 1;67(3):332-338. doi: 10.1097/MAT.0000000000001302.
- Derived from this study: PubMed 33455938Rieder M, Schubach F, Schmoor C, von Spee-Mayer C, Wengenmayer T, Rilinger J, Staudacher D, Bode C, Duerschmied D, Supady A. Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation: protocol for a randomised, controlled, open-label intervention, multicentre trial. BMJ Open. 2021 Jan 17;11(1):e043345. doi: 10.1136/bmjopen-2020-043345.
- 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.
Alexander Supady, Dr., MPH principal investigator
University Clinic Freiburg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vv-ECMO + cytokine adsorption (Cytosorb adsorber) and vv-ECMO only (no cytokine adsorption) in people with Coronavirus Infection and COVID, run by Dr. Alexander Supady at 3 sites in Germany.
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 2 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: paused, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
IL-6 reduction by 75% or more after 72 hours as compared to the baseline measurement (time frame: 72 hours). 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 NCT04385771, 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 15 Mar 2021.