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

  • STATUS
    Recruiting
  • days left to enroll
    39
  • participants needed
    310
  • sponsor
    Dow University of Health Sciences
Updated on 30 August 2021

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

Description

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. Phase I/II trial was completed and shown potential safety and efficacy of the drug Anti COVID 19 intravenous immunoglobulin (C-IVIG) in severe and critical patient of COVID 19.

This trial aim is to investigate the safety and efficacy of passive immunization in severe COVID 19 patients in phase II/III. The trial will be randomized, single-blinded, superiority trial, through parallel-group design. The participant will be either to receive C-IVIG with Standard of care or Placebo with Standard of care. The study will be consist of 310 participant in which 155 will receive single dose of C-IVIG (0.15g/kg) with standard of care and 155 will receive placebo with 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 anti-pyretic.

Randomized test patients will receive single dose of C-IVIG in 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: placebo with standard hospital care only

Details
Condition COVID19
Treatment Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)
Clinical Study IdentifierNCT04891172
SponsorDow University of Health Sciences
Last Modified on30 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Above 18 years of age
Have positive COVID PCR on nasopharyngeal and/or oropharyngeal swabs
classified as severe COVID-19 according to WHO guideline
Consent given by the patient or first degree relative

Exclusion Criteria

Critical COVID-19 patients
Pregnant females
Previous allergic reaction to immunoglobulin treatment
Patient given immunomodulatory drug (e.g. tociluzumab)
Patient requiring 2 inotropic agents to maintain blood pressures
Known case of any autoimmune disorder
Chronic kidney disease
Known case of thromboembolic disorder
Aseptic meningitis
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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