Severe ill Patients will be enrolled in the study (n=310) after duly filled consentforms. Recipients will be divided into 2 group, each group contain 155 patients tocompare Safety and efficacy of patients in Clinical Trial phase II/III. One Group willreceive 0.15g/kg single dose of anti COVID 19 intravenously immunoglobulin (C-IVIG)develop from convalescent plasma of recovered patients from COVID 19, along with Standardof care. The Comparator group will only receive standard of Care
The 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 it to prepare IVIG formulation to treat severe and critically ill
COVID-19 patients. Phase I/II trial was completed and showed potential safety and
efficacy of the drug Anti COVID-19 intravenous immunoglobulin (C-IVIG) in severe and
critical patients with COVID-19.
This trial's aim is to investigate the safety and efficacy of passive immunization in
severe COVID-19 patients in phase II/III. The trial will be a randomized, single-blinded,
superiority trial, through parallel-group design. The participant will either receive
C-IVIG with Standard of care or receive only Standard of care. The study will consist of
310 participants of which 155 will receive a single dose of C-IVIG (0.15g/kg) with the
standard of care and 155 will receive only the standard of care. Standard of care is
standard hospital care which includes airway support, anti-viral medication, antibiotics,
fluid resuscitation, hemodynamic support, steroids, painkillers, and antipyretics.
Randomized test patients will receive a single dose of C-IVIG in the following two dosage
groups:
Group 1 (Test): Severe COVID-19 patients: Single dose of 0.15g/Kg with standard hospital
care
Group 2 (Comparator): Severe COVID-19 patients: only standard hospital care only
Biological: Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)
Intervention arm will receive single dose of 0.15g/kg C-IVIG. This will be infused within
period of 16 hours intravenously. Additionally, all participants will receive same
standard care.
Standard Care as per hospital protocol, which may include:
Airway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic
Support, Steroids, Painkillers, Anti-Pyretics, anti coagulant
Inclusion Criteria:
1. Above 18 years of age
2. Have positive COVID PCR on nasopharyngeal and/or oropharyngeal swabs
3. classified as severe* COVID-19 according to WHO guideline (5L-15L of oxygen
requirement on FM, NRM)
4. Consent given by the patient or first degree relative
Exclusion Criteria:
1. Critical COVID-19 patients [ non-invasive ventilation (HFNC, BiPAP, CPAP) and
invasive ventilation],
2. Pregnant females
3. Previous allergic reaction to immunoglobulin treatment
4. Known case of any autoimmune disorder
5. Chronic kidney disease
6. Known case of thromboembolic disorder
7. Aseptic meningitis
Dow University of Health Sciences
Karachi, Sindh, Pakistan
Investigator: Prof. Dr. Mohammed Saeed Quraishy, FRCS, FCPS
Contact: +91-03008240234
vc@duhs.edu.pk
Shaukat Ali, PhD
+92-3363010185
ali.shaukat@duhs.edu.pk
Muneeba Sayeed, FCPS
+92-3002167826
muneeba.sayeed@yahoo.com
Shaukat Ali, PhD, Principal Investigator
Dow University of Health Sciences, Principal Dow College of Biotechnology