Clinical trial NCT06223984: Combined Use of Immunoglobulin and Pulse Steroid Therapies in Severe Covid-19 Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulse Steroid and Immunoglobulins Drugs in Covid 19 Patients
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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))

Exclusion Criteria:

* 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

Primary outcomes:
measure: absolute lymphocyte , white blood cell , neutrophil , ferritin , dimer , crp counts
timeFrame: on the first day of hospitalization, in the middle and at discharge from intensive care
measure: SOFA score
timeFrame: Day 1
measure: all cause mortality rate
timeFrame: 28 days
measure: ventilation free days
timeFrame: 28 days
measure: ICU free days
timeFrame: 28 days
measure: invasive and non-invasive respiratory support
timeFrame: 28 days
measure: vasopressor support
timeFrame: 28 days
measure: renal replacement therapy
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
References: