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

Last updated: October 12, 2022
Sponsor: Dow University of Health Sciences
Overall Status: Active - Recruiting

Phase

2/3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04891172
C-IVIG-02
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 oxygenrequirement on FM, NRM)
  4. Consent given by the patient or first degree relative

Exclusion

Exclusion Criteria:

  1. Critical COVID-19 patients [ non-invasive ventilation (HFNC, BiPAP, CPAP) and invasiveventilation],
  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

Study Design

Total Participants: 310
Study Start date:
August 01, 2021
Estimated Completion Date:
December 02, 2022

Study 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

Connect with a study center

  • Dow University of Health Sciences

    Karachi, Sindh 74200
    Pakistan

    Active - Recruiting

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