Combined Use of Immunoglobulin and Pulse Steroid Therapies in Severe Covid-19 Patients

NCT ID: NCT06223984

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-30
• Study Completion Date: 2020-11-14

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.

Conditions

Pulse Steroid and Immunoglobulins Drugs in Covid 19 Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

the group receiving standard treatment

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).

Group Type: ACTIVE_COMPARATOR

pulse steroid and nanogam

Intervention Type: DRUG

patients received pulse steroid and ivig treatments in addition to standard treatment.

the group receiving IVIG and pulse steroid

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.

Group Type: ACTIVE_COMPARATOR

pulse steroid and nanogam

Intervention Type: DRUG

patients received pulse steroid and ivig treatments in addition to standard treatment.

Interventions

pulse steroid and nanogam

patients received pulse steroid and ivig treatments in addition to standard treatment.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dursun Elmas

specialist doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Konya City Hospital

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

konya city hospital,konya

Identifier Type: -

Identifier Source: org_study_id