Anti COVID 19 Hyperimmune Intravenous Immunoglobulin (C-IVIG) Therapy for Severe COVID-19 Patients

Dow University of Health Sciences

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Covid19

Treatments: Biological: Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)

Study type: Interventional

Funder types: Other

Identifiers

NCT04891172

C-IVIG-02

Details and patient eligibility

About

Severe ill Patients will be enrolled in the study (n=310) after duly filled consent forms. Recipients will be divided into 2 group, each group contain 155 patients to compare Safety and efficacy of patients in Clinical Trial phase II/III. One Group will receive 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 Standard of care. The Comparator group will only receive standard of Care

Full description

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

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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310 participants in 2 patient groups

Control

No Intervention group

Description:

The Control group will be receive Standard of care only

C-IVIG

Experimental group

Description:

The intervention group will receive the single dose of C-IVIG (0.15g/kg) with Standard of Care

Treatment:

Biological: Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)