SARS-CoV-2 Antibodies Based IVIG Therapy for COVID-19 Patients
- Conditions
- COVID-19
- Interventions
- Biological: SARS-CoV-2 antibody based IVIG therapy
- Registration Number
- NCT04521309
- Lead Sponsor
- Dow University of Health Sciences
- Brief Summary
Severe and critically ill patients will be enrolled in the study (50 patients) after duly filled consent forms. Recipients shall be divided in to 5 groups with 10 patients per group to compare clinical efficacy and safety of patients in clinical phase I/phase II study. Each group shall receive particular single dose of Intravenously administered Immunoglobulins (IVIG) developed from convalescent plasma of recovered COVID-19 individual , an experimental drug along with standard treatment except for control group which will receive standard treatment only.
- Detailed Description
Passive immunization using intravenous immunoglobulins (IVIG) has been tested for treating previous viral outbreaks and holds the potential to save lives in the current crisis. Recently researchers from China reported satisfactory recovery of critically ill Corona Virus Disease 2019 (COVID 19) patients when high dose intravenous immunoglobulin (IVIG) were administered.
Research team at Dow University of Health Sciences has purified immunoglobulin (both SARS-CoV 2 antibodies and existing antibodies) from convalescent plasma of COVID19 individuals and pooled to prepared IVIG formulation to treat severe and critically ill COVID-19 patients. To evaluate safety of the formulation animal (rats) safety trials and survival of all the animals were observed.
It is intended to assess safety and efficacy of experimental the IVIG treatment in severe and critically ill COVID 19 patients through phase I/phase II randomized single blinded clinical trial with fifty study participants. FDA outlined criteria for passive immunization using convalescent plasma, which will be used for recruiting participants in the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Above 18 years of age
- Have positive SARS-CoV-2 PCR on nasopharyngeal and/or oropharyngeal swabs
- Admitted in isolation ward and ICU of institutes affiliated with DUHS
- have severe or critical COVID 19 as judged by the treating physician
- Consent given by the patient or first degree relative
- Pregnancy
- Previous allergic reaction to immunoglobulin treatment
- Ig A deficiency
- Patient requiring 2 inotropic agents to maintain blood pressures
- Known case of any autoimmune disorder
- Acute kidney injury or chronic renal failure
- Known case of thromboembolic disorder
- Aseptic meningitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description IVIG dose: 0.20 g/kg SARS-CoV-2 antibody based IVIG therapy Standard Care + Single dose of 0.25 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients IVIG dose: 0.30 g/kg SARS-CoV-2 antibody based IVIG therapy Standard Care + Single dose of 0.35 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients IVIG dose: 0.25 g/kg SARS-CoV-2 antibody based IVIG therapy Standard Care + Single dose of 0.30 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients IVIG dose: 0.15 g/kg SARS-CoV-2 antibody based IVIG therapy Standard Care + Single dose of 0.20 g/Kg anti-COVID-19 IVIG (experimental drug prepared at DUHS) n= 10 patients
- Primary Outcome Measures
Name Time Method Adverse events during hospital stay 28 days Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)
Days to Hospital Discharge 28 days Duration from day of enrollment in study to Day of hospital discharge
Requirement of supplemental oxygen support 28 days Number of days required for invasive or non-invasive oxygen supply during hospital stay as per oxygen saturation status of patient
Change in neutrophil lymphocyte ratio 28 days change in neutrophil lymphocyte ratio from baseline will be used to monitor inflammation
Number of days on assisted ventilation 28 days Number of days a participant will be requiring assisted ventilation both invasive and noninvasive
28 Days mortality 28 days All cause mortality of participants will be monitored for 28 days to assess the safety and efficacy of IVIG treatment.
Days to step down 28 days Shifting from ICU to ward
Change in C-Reactive Protein (CRP) levels 28 days Change in C-Reactive Protein (CRP) levels from baseline will be used to monitor inflammation
- Secondary Outcome Measures
Name Time Method Change in radiological (X-ray) findings 28 days Any change seen in radiological chest X-ray findings
Change in Sodium levels 28 days Change in electrolytes (Sodium) seen in participants
Change in Chloride levels 28 days Change in electrolytes (Chloride) seen in participants
Change in fever 28 days Change in body temperature from baseline will be used to monitor safety and efficacy
Change in Ferritin levels 28 days change in Ferritin level from baseline will be used to monitor inflammation and immune dysregulation
Days to negative SARS-CoV-2 Polymerase Chain Reaction (PCR) test 28 days Time taken for participant to receive negative COVID-19 PCR test
Anti-SARS-CoV-2 Antibody 28 days Anti-SARS-CoV-2 antibody titre from blood measured by semi-qualitative method
Change in Potassium levels 28 days Change in electrolytes (Potassium) seen in participants
Change in Bicarbonate levels 28 days Change in electrolytes (Bicarbonate) seen in participants
Change in lactate dehydrogenase (LDH) levels 28 days change in LDH from baseline will be used to monitor infections and tissue health
Trial Locations
- Locations (1)
Dow University of Health Sciences
🇵🇰Karachi, Sindh, Pakistan