Pulse Steroid and Immunoglobulins Drugs in Covid 19 PatientsPhase 4NCT06223984
Combined Use of Immunoglobulin and Pulse Steroid Therapies in Severe Covid-19 Patients
A Phase 4 study testing pulse steroid and nanogam in people with Pulse Steroid and Immunoglobulins Drugs in Covid 19 Patients, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In December 2019, SARS-COV-2 was isolated from patients for the first time . It then rapidly turned into a pandemic affecting the whole world.While most Covid patients survive the disease with mild symptoms, some may develop severe organ failure and respiratory failure requiring mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulse Steroid and Immunoglobulins Drugs in Covid 19 Patients
- What is being tested?
- pulse steroid and nanogam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2020to 14 Nov 2020
- Phase
- Phase 4
- 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
- Adult patients with 2019-ncov infection confirmed by PCR;
- Absolute value of lymphocytes < 0. 6x 109/L;
- Brescia-COVID respiratory severity scale (BCRSS) score ≥3
- Hyperinflammation (defined as elevation of C-reactive protein (CRP) ≥50 mg/L or ferritin ≥500 ng/ ml)
- Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 300 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O))
Who cannot join
- Age < 18
- Pregnant
- Allergic to experimental drugs
- The underlying disease is very serious and the expected survival time is less than 6 months (such as advanced malignant tumor);
- COPD or end-stage lung disease requires home oxygen therapy
- Expected survival time not exceeding 48 hours
- Autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Retrospective Clinical Results of the Combined Use of Immunoglobulin and Pulse Steroid Therapies in Severe Covid-19 Patients Followed in Intensive Care Unit
In December 2019, SARS-COV-2 was isolated from patients for the first time . It then rapidly turned into a pandemic affecting the whole world.While most Covid patients survive the disease with mild symptoms, some may develop severe organ failure and respiratory failure requiring mechanical ventilation. COVİD-19 pneumonia may progress into acute respiratory distress syndrome (ARDS). The most important reason for this has been shown in studies; is thought to be because a group of patients develop a cytokine storm-associated hyperinflammatory state characterized by features of macrophage activation syndrome (MAS). The aim of this study was to evaluate the clinical outcomes of the combined use of pulse steroid and intravenous immunoglobulin therapy in patients with severe COVID-19 with severe respiratory distress in intensive care unit.
Read the detailed description
In December 2019, SARS-COV-2 was isolated from patients for the first time . It then rapidly turned into a pandemic affecting the whole world.While most Covid patients survive the disease with mild symptoms, some may develop severe organ failure and respiratory failure requiring mechanical ventilation . COVİD-19 pneumonia may progress into acute respiratory distress syndrome (ARDS) , diffuse alveolar damage, and vascular endothelitis, which is comlicated with trombosis and hemorrhage. .
The most important reason for this has been shown in studies; is thought to be because a group of patients develop a cytokine storm-associated hyperinflammatory state characterized by features of macrophage activation syndrome (MAS), such as lymphopenia, elevated ferritin and elevated d-dimer. Increased proinflammatory cytokine release, especially as a result of stimulation of the immune system, has been shown to be associated with this hyperinflammatory phase .
The immune system triggered by viral infections is essential for fighting pathogens. However, the excessive production of pro-inflammatory cytokines caused by SARS-COV-2 can cause tissue damage that can lead to fatal acute respiratory distress .
Therefore, aiming to suppress the cytokine storm seems to be of critical importance for COVID-19 and similar respiratory infections that cause acute respiratory distress . Many agents have been used for this purpose, but there is no clear evidence for the management and treatment of cytokine storm.
Immunosuppression plays an important role in the treatment of cytokine storm. Studies have reported positive results of steroids used for this purpose in elderly COVID-19 patients . Various immunomodulatory agents have also been used for this purpose. In addition to treatments targeting a specific molecule such as IL-6, IL-1, agents that affect various branches of the immune inflammatory system such as intravenous immunoglobulin can be used .
The aim of this study was to evaluate the clinical outcomes of the combined use of pulse steroid and intravenous immunoglobulin therapy in patients with severe COVID-19 with severe respiratory distress in intensive care unit.
- Being tested
- pulse steroid and nanogam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulse steroid and nanogamDrug
patients received pulse steroid and ivig treatments in addition to standard treatment.
| Study group | Role | What they receive |
|---|---|---|
| the group receiving standard treatment | Active comparator | In the group receiving standard treatment, hydroxychloroquine (400 mg/day for 5 days), low moleculer weight heparin, acetylsalicylic acid, favipiravir (3200 mg on day 1, 1200 mg on days 2-5). Receives: Drug: pulse steroid and nanogam |
| the group receiving IVIG and pulse steroid | Active comparator | In the IVIG and pulse steroid group, patients received pulse steroid (250 mg/day methylprednisolone for 5 days) and intravenous immunoglobulin (400 mg/kg/day for 5 days) in addition to standard treatment. The IVIG preparations given to the patients were in 100 ml volume and 10% concentration, and the commercial name was Nanogam. Receives: Drug: pulse steroid and nanogam |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute lymphocyte , white blood cell , neutrophil , ferritin , dimer , crp counts
counts on the first day of hospitalization, in the middle and at discharge from intensive care
Measured: on the first day of hospitalization, in the middle and at discharge from intensive care
SOFA score
SOFA score at Day 1, with scores range from 0 to 24 and higher score means worse outcome
Measured: Day 1
all cause mortality rate
died at day 28
Measured: 28 days
ventilation free days
Measured: 28 days
ICU free days
Measured: 28 days
invasive and non-invasive respiratory support
intubated
Measured: 28 days
vasopressor support
vasopressor support needs
Measured: 28 days
renal replacement therapy
renal replacement therapy needs
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start30 Mar 2020
- Primary completion14 Nov 2020
- Study completion14 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse Steroid and Immunoglobulins Drugs in Covid 19 PatientsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dursun Elmas, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223984
- Sponsor's protocol ID
- konya city hospital,konya
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Retrospective Clinical Results of the Combined Use of Immunoglobulin and Pulse Steroid Therapies in Severe Covid-19 Patients Followed in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06223984
- Acronym / sponsor ID
- konya city hospital,konya
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 14 Nov 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 25 Jan 2024 (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, SARS-COV-2 was isolated from patients for the first time . It then rapidly turned into a pandemic affecting the whole world.While most Covid patients survive the disease with mild symptoms, some may develop severe organ failure and respiratory failure requiring mechanical ventilation. COVİD-19 pneumonia may progress into acute respiratory distress syndrome (ARDS). The most important reason for this has been shown in studies; is thought to be because a group of patients develop a cytokine storm-associated hyperinflammatory state characterized by features of macrophage activation syndrome (MAS). The aim of this study was to evaluate the clinical outcomes of the combined use of pulse steroid and intravenous immunoglobulin therapy in patients with severe COVID-19 with severe respiratory distress in intensive care unit.
Detailed description
In December 2019, SARS-COV-2 was isolated from patients for the first time . It then rapidly turned into a pandemic affecting the whole world.While most Covid patients survive the disease with mild symptoms, some may develop severe organ failure and respiratory failure requiring mechanical ventilation . COVİD-19 pneumonia may progress into acute respiratory distress syndrome (ARDS) , diffuse alveolar damage, and vascular endothelitis, which is comlicated with trombosis and hemorrhage. .
The most important reason for this has been shown in studies; is thought to be because a group of patients develop a cytokine storm-associated hyperinflammatory state characterized by features of macrophage activation syndrome (MAS), such as lymphopenia, elevated ferritin and elevated d-dimer. Increased proinflammatory cytokine release, especially as a result of stimulation of the immune system, has been shown to be associated with this hyperinflammatory phase .
The immune system triggered by viral infections is essential for fighting pathogens. However, the excessive production of pro-inflammatory cytokines caused by SARS-COV-2 can cause tissue damage that can lead to fatal acute respiratory distress .
Therefore, aiming to suppress the cytokine storm seems to be of critical importance for COVID-19 and similar respiratory infections that cause acute respiratory distress . Many agents have been used for this purpose, but there is no clear evidence for the management and treatment of cytokine storm.
Immunosuppression plays an important role in the treatment of cytokine storm. Studies have reported positive results of steroids used for this purpose in elderly COVID-19 patients . Various immunomodulatory agents have also been used for this purpose. In addition to treatments targeting a specific molecule such as IL-6, IL-1, agents that affect various branches of the immune inflammatory system such as intravenous immunoglobulin can be used .
The aim of this study was to evaluate the clinical outcomes of the combined use of pulse steroid and intravenous immunoglobulin therapy in patients with severe COVID-19 with severe respiratory distress in intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the group receiving standard treatment | Active comparator | Drug: pulse steroid and nanogamIn the group receiving standard treatment, hydroxychloroquine (400 mg/day for 5 days), low moleculer weight heparin, acetylsalicylic acid, favipiravir (3200 mg on day 1, 1200 mg on days 2-5). |
| the group receiving IVIG and pulse steroid | Active comparator | Drug: pulse steroid and nanogamIn the IVIG and pulse steroid group, patients received pulse steroid (250 mg/day methylprednisolone for 5 days) and intravenous immunoglobulin (400 mg/kg/day for 5 days) in addition to standard treatment. The IVIG preparations given to the patients were in 100 ml volume and 10% concentration, and the commercial name was Nanogam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with 2019-ncov infection confirmed by PCR;
- Absolute value of lymphocytes < 0. 6x 109/L;
- Brescia-COVID respiratory severity scale (BCRSS) score ≥3
- Hyperinflammation (defined as elevation of C-reactive protein (CRP) ≥50 mg/L or ferritin ≥500 ng/ ml)
- Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 300 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O))
Key exclusion criteria (7 listed)
- Age < 18
- Pregnant
- Allergic to experimental drugs
- The underlying disease is very serious and the expected survival time is less than 6 months (such as advanced malignant tumor);
- COPD or end-stage lung disease requires home oxygen therapy
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 |
|---|---|---|
| pulse steroid and nanogampatients received pulse steroid and ivig treatments in addition to standard treatment. | Drug | the group receiving IVIG and pulse steroid, the group receiving standard treatment |
Primary outcome
absolute lymphocyte , white blood cell , neutrophil , ferritin , dimer , crp counts
Time frame: on the first day of hospitalization, in the middle and at discharge from intensive care
counts on the first day of hospitalization, in the middle and at discharge from intensive care
SOFA score
Time frame: Day 1
SOFA score at Day 1, with scores range from 0 to 24 and higher score means worse outcome
all cause mortality rate
Time frame: 28 days
died at day 28
ventilation free days
Time frame: 28 days
ICU free days
Time frame: 28 days
invasive and non-invasive respiratory support
Time frame: 28 days
intubated
vasopressor support
Time frame: 28 days
vasopressor support needs
renal replacement therapy
Time frame: 28 days
renal replacement therapy needs
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 25 Jan 2024.
- Individual participant dataSharing planned: Undecided
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 Phase 4 study testing pulse steroid and nanogam in people with Pulse Steroid and Immunoglobulins Drugs in Covid 19 Patients, run by Konya City Hospital at 1 site in Turkey (Türkiye).
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 7 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 25 Jan 2024. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
absolute lymphocyte , white blood cell , neutrophil , ferritin , dimer , crp counts (time frame: on the first day of hospitalization, in the middle and at discharge from intensive care). The study lists 8 primary outcomes in all. 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 25 Jan 2024.