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.
Biological: SARS-CoV-2 antibody based IVIG therapy
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
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Dow University of Health Sciences
Karachi, Sindh, Pakistan
Dr.Shaukat Ali, PhD, Principal Investigator
Dow University of Health Sciences, Principal Dow College of Biotechnology