SARS-CoV-2 Antibodies Based IVIG Therapy for COVID-19 Patients

Dow University of Health Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Biological: SARS-CoV-2 antibody based IVIG therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04521309

biotech001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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50 participants in 5 patient groups

Control

No Intervention group

Description:

Standard care only n = 10 patients.

IVIG dose: 0.15 g/kg

Experimental group

Description:

Standard Care + Single dose of 0.20 g/Kg anti-COVID-19 IVIG (experimental drug prepared at DUHS) n= 10 patients

Treatment:

Biological: SARS-CoV-2 antibody based IVIG therapy

IVIG dose: 0.20 g/kg

Experimental group

Description:

Standard Care + Single dose of 0.25 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients

Treatment:

Biological: SARS-CoV-2 antibody based IVIG therapy

IVIG dose: 0.25 g/kg

Experimental group

Description:

Standard Care + Single dose of 0.30 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients

Treatment:

Biological: SARS-CoV-2 antibody based IVIG therapy

IVIG dose: 0.30 g/kg

Experimental group

Description:

Standard Care + Single dose of 0.35 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients

Treatment:

Biological: SARS-CoV-2 antibody based IVIG therapy