Status:

UNKNOWN

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

Lead Sponsor:

Dow University of Health Sciences

Collaborating Sponsors:

Higher Education Commission (Pakistan)

Conditions:

Covid19

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief 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 pa...

Detailed 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...

Eligibility Criteria

Inclusion

  • Above 18 years of age
  • Have positive COVID PCR on nasopharyngeal and/or oropharyngeal swabs
  • classified as severe\* COVID-19 according to WHO guideline (5L-15L of oxygen requirement on FM, NRM)
  • Consent given by the patient or first degree relative

Exclusion

  • Critical COVID-19 patients \[ non-invasive ventilation (HFNC, BiPAP, CPAP) and invasive ventilation\],
  • Pregnant females
  • Previous allergic reaction to immunoglobulin treatment
  • Known case of any autoimmune disorder
  • Chronic kidney disease
  • Known case of thromboembolic disorder
  • Aseptic meningitis

Key Trial Info

Start Date :

August 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 2 2022

Estimated Enrollment :

310 Patients enrolled

Trial Details

Trial ID

NCT04891172

Start Date

August 1 2021

End Date

December 2 2022

Last Update

October 17 2022

Active Locations (1)

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1

Dow University of Health Sciences

Karachi, Sindh, Pakistan, 74200