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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Patient groups will receive IVIG prepared from pooled convalescent plasma from recovered COVID-19 patients. This will be administered sequentially and in varying dosages, infused over a period of 12 hours, intravenously.Additionally, all treatment groups will receive same standard care as control group. Standard Care as per hospital protocol, which may include: Airway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic Support, Steroids, Painkillers, Anti-Pyretics
Dow University of Health Sciences
Karachi, Sindh, Pakistan
28 Days mortality
All cause mortality of participants will be monitored for 28 days to assess the safety and efficacy of IVIG treatment.
Time frame: 28 days
Requirement of supplemental oxygen support
Number of days required for invasive or non-invasive oxygen supply during hospital stay as per oxygen saturation status of patient
Time frame: 28 days
Number of days on assisted ventilation
Number of days a participant will be requiring assisted ventilation both invasive and noninvasive
Time frame: 28 days
Days to step down
Shifting from ICU to ward
Time frame: 28 days
Days to Hospital Discharge
Duration from day of enrollment in study to Day of hospital discharge
Time frame: 28 days
Adverse events during hospital stay
Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)
Time frame: 28 days
Change in C-Reactive Protein (CRP) levels
Change in C-Reactive Protein (CRP) levels from baseline will be used to monitor inflammation
Time frame: 28 days
Change in neutrophil lymphocyte ratio
change in neutrophil lymphocyte ratio from baseline will be used to monitor inflammation
Time frame: 28 days
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Change in Ferritin levels
change in Ferritin level from baseline will be used to monitor inflammation and immune dysregulation
Time frame: 28 days
Change in lactate dehydrogenase (LDH) levels
change in LDH from baseline will be used to monitor infections and tissue health
Time frame: 28 days
Change in radiological (X-ray) findings
Any change seen in radiological chest X-ray findings
Time frame: 28 days
Days to negative SARS-CoV-2 Polymerase Chain Reaction (PCR) test
Time taken for participant to receive negative COVID-19 PCR test
Time frame: 28 days
Anti-SARS-CoV-2 Antibody
Anti-SARS-CoV-2 antibody titre from blood measured by semi-qualitative method
Time frame: 28 days
Change in fever
Change in body temperature from baseline will be used to monitor safety and efficacy
Time frame: 28 days
Change in Sodium levels
Change in electrolytes (Sodium) seen in participants
Time frame: 28 days
Change in Potassium levels
Change in electrolytes (Potassium) seen in participants
Time frame: 28 days
Change in Chloride levels
Change in electrolytes (Chloride) seen in participants
Time frame: 28 days
Change in Bicarbonate levels
Change in electrolytes (Bicarbonate) seen in participants
Time frame: 28 days