Clinical trial NCT04521309: SARS-CoV-2 Antibodies Based IVIG Therapy for COVID-19 Patients
Official title: Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Antibodies Based Intravenous Immunoglobulin (IVIG) Therapy for Severe and Critically Ill COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: COVID19 ( Corona Virus Disease -2019)
SARS-CoV-2 (Severe Acute respiratory syndrome Coronavirus 2)
Passive Immunization
Intravenous Immunoglobulin (IVIG)
Pooled convalescent Plasma
Critically ill COVID-19 patients
Severe COVID-19 patients
Antibody
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Higher Education Commission (Pakistan)
First posted: 2020-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 28 Days mortality
timeFrame: 28 days
measure: Requirement of supplemental oxygen support
timeFrame: 28 days
measure: Number of days on assisted ventilation
timeFrame: 28 days
measure: Days to step down
timeFrame: 28 days
measure: Days to Hospital Discharge
timeFrame: 28 days
measure: Adverse events during hospital stay
timeFrame: 28 days
measure: Change in C-Reactive Protein (CRP) levels
timeFrame: 28 days
measure: Change in neutrophil lymphocyte ratio
timeFrame: 28 days
Secondary outcomes:
measure: Change in Ferritin levels
timeFrame: 28 days
measure: Change in lactate dehydrogenase (LDH) levels
timeFrame: 28 days
measure: Change in radiological (X-ray) findings
timeFrame: 28 days
measure: Days to negative SARS-CoV-2 Polymerase Chain Reaction (PCR) test
timeFrame: 28 days
measure: Anti-SARS-CoV-2 Antibody
timeFrame: 28 days
measure: Change in fever
timeFrame: 28 days
measure: Change in Sodium levels
timeFrame: 28 days
measure: Change in Potassium levels
timeFrame: 28 days
measure: Change in Chloride levels
timeFrame: 28 days
measure: Change in Bicarbonate levels
timeFrame: 28 days
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences, Principal Dow College of Biotechnology
name: Dr.Shaukat Ali, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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