Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Antibodies Based Intravenous Immunoglobulin (IVIG) Therapy for Severe and Critically Ill COVID-19 Patients
Phase: PHASE1
Conditions: COVID-19
Sponsor: Dow University of Health Sciences

 
 
 
 
 
 
SARS-CoV-2 Antibodies Based IVIG 
Therapy for COVID-19 Patients 
 
Clinical Trials.gov: NCT04521309 
September 29, 2020 
 
 
 

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Study Protocol 
Objective:  
To investigate clinical efficacy of anti COVID-19 Intravenous Immunoglobulin (IVIG) therapy 
for passive immunization of COVID-19 patients. 
 Methodology 
 Plasma collection from donors (recovered COVID-19 individuals): 
 1. Selection of donor according to World Health Organization (WHO) and Federal Drug Agency 
(FDA) guidelines 
Inclusion Criteria for Donor  
Exclusion criteria for Donor 
1. Submitted signed consent 
a. Pre-existing condition Contra indicative for 
donating blood (HIV, viral hepatitis, tuberculosis, 
syphilis, oncological conditions, malaria) 
2. Eligible to donate blood 
b. Bleeding tendency 
3. Negative for HIV, HBV, HCV, syphilis and 
malarial parasite 
c. Anemia 
4. Prior diagnosis of COVID-19 documented 
by a laboratory test 
d. Fever of unknown origin 
5. Complete resolution of symptoms at least 14 
days prior to donation 
 
6. Female donors negative for HLA antibodies 
or male donors 
 
7. Negative results for COVID-19 either from 
one or more nasopharyngeal swab specimens 
or by a molecular diagnostic test from blood. 
 
8. Defined SARS-CoV-2 neutralizing antibody 
titers, if testing can be conducted (e.g., 
optimally greater than 1:320) 
 
 
 
 
STUDY PROTOCOL 

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2. Plasma Collection and separation: 
300-1000 ml plasma will be collected from consenting COVID-19 recovered patients 
(two weeks after recovery and having evidence of negative PCR for SARS CoV-2) using 
plasmapheresis technique. Plasmapheresis is a technique where using a machine the 
blood components are separated, keeping the required component, in this case plasma, 
and returning other components like RBCs. Plasma will be stored according to WHO 
guidelines. Aliquot of plasma will be subjected to ABO blood typing and screened for 
syphilis, malarial parasite HIV, HBV, HCV, and COVID–19 by Nucleic Acid Test 
(NAT). The screened stored plasma qualifying safety criteria will be pooled and 
fractionated to obtain Anti-COVID hyperimmune immunoglobulin. 
Administration of extracted IgG in respective doses by medical Experts and researchers in 
selected recipient 
Eligibility Criteria for Recipient: 
Revised Inclusion criteria for study 
participant (Covid-19 patients) 
Exclusion criteria for Recipient 
 1. Above 18 years of age 
a. Pregnancy 
2. 
Have 
positive 
COVID 
PCR 
on 
nasopharyngeal and/or oropharyngeal swabs 
b. Previous allergic reaction to 
immunoglobulin treatment 
3. Admitted in isolation ward and ICU of 
institutes affiliated with DUHS 
c. Ig A deficiency 
4. Have severe or life threatening COVID as 
judged by the treating physician 
d. Patient requiring 2 inotropic agents to 
maintain blood pressures 
5. Consent given by the patient or first 
degree relative 
e. Known case of any autoimmune disorder 
Severe COVID-19 is defined by one or 
more of the following: 
f. Acute kidney injury or chronic renal failure 
Dyspnea 
g. Known case of thromboembolic disorder 
Respiratory frequency ≥ 30/min 
h. Aseptic meningitis 
Blood oxygen saturation ≤ 90% 
 

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Partial pressure of arterial oxygen to 
fraction of inspired oxygen ratio < 300 
 
Lung infiltrates > 50% within 24 to 48 hours  
Life-threatening COVID-19 is defined as 
one or more of the following: 
 
Respiratory failure 
 
Septic shock 
 
Multiple organ dysfunction or failure 
 
Study Design 
This is a phase I/II single centered, randomized controlled, single-blinded trial, through parallel-
group design with sequential assignment. Participants will be randomized either to receive both 
C-IVIG and standard care or only standard care (4:1). The study consists of intervention 
comprising of four arms with each study arm containing 10 participants. All participants receive 
standard hospital care which includes airway support, anti-viral medication, antibiotics, fluid 
resuscitation, hemodynamic support, steroids, painkillers, and anti-pyretic.  
Randomized test patients will receive single dose of C-IVIG in following four dosage groups: 
Group 1: 0.15g/Kg with standard hospital care 
Group 2: 0.2g/Kg with standard hospital care 
Group 3: 0.25g/Kg with standard hospital care 
Group 4: 0.3g/Kg with standard hospital care 
Group 5 (comparator) will receive standard hospital care only.