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

October 12, 2022 updated by: Dow University of Health Sciences

Phase II/III Clinical Trial Study to Evaluate Efficacy and Safety of Anti COVID 19 Intravenous Immunoglobulin (C-IVIG) Therapy for Severe COVID-19 Patients

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Recruiting
        • Dow University of Health Sciences
        • Contact:
          • Prof. Dr. Mohammed Saeed Quraishy, FRCS, FCPS
          • Phone Number: +91-03008240234
          • Email: vc@duhs.edu.pk
        • Contact:
        • Principal Investigator:
          • Prof. Dr. Mohammed Saeed Quraishy, FRCS
        • Principal Investigator:
          • Dr. Shaukat Ali, PhD
        • Principal Investigator:
          • Dr. Shobha Luxmi, FCPS
        • Sub-Investigator:
          • Dr. Farah Farhan, PhD
        • Principal Investigator:
          • Mr. Abdul Samad Khan, M.Phil
        • Sub-Investigator:
          • Ms. Fatima Anjum, M.Sc
        • Sub-Investigator:
          • Dr. Sheikh Muhammad Muhaymin, MBBS
        • Sub-Investigator:
          • Mr. Mir Rashid Ali, M.Sc
        • Sub-Investigator:
          • Mr. Syed Muneeb Uddin, M.Sc
        • Sub-Investigator:
          • Ms. Ayesha Ali, M.Sc
        • Sub-Investigator:
          • Mr. Elisha Shalim, BS
        • Sub-Investigator:
          • Mr. Mujtaba Khan, BS
        • Principal Investigator:
          • Dr. Muneeba Sayeed, FCPS
        • Sub-Investigator:
          • Ms. Tehreem Mushtaq, BS
        • Sub-Investigator:
          • Mr. Faisal shahab, M.Sc
        • Sub-Investigator:
          • Mr. Muhammad Ali, BS
        • Sub-Investigator:
          • Mr. Mustafa Haider, BE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The Control group will be receive Standard of care only
Experimental: C-IVIG
The intervention group will receive the single dose of C-IVIG (0.15g/kg) with Standard of Care
Biological: Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)

Intervention arm will receive single dose of 0.15g/kg C-IVIG. This will be infused within period of 16 hours intravenously. Additionally, all participants will receive same standard care.

Standard Care as per hospital protocol, which may include:

Airway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic Support, Steroids, Painkillers, Anti-Pyretics, anti coagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 day Mortality
Time Frame: 28 days
All cause mortality of participants will be monitored for 28 days to asses the safety and efficacy of C-IVIG
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate and serious adverse event during hospital Stay
Time Frame: 28 days
Immediate adverse event (within 24 hours) and serious adverse event (throughout the hospital stay) which will be observed
28 days
Clinical Status of follow-up days according to 7-Catergory Ordinal Scale
Time Frame: 28 days

Clinical Status of follow-up days according to 7-Catergory Ordinal Scale

  1. Not hospitalized and no limitations of activities
  2. Not hospitalized, with limitation of activities, home oxygen requirement, or both
  3. Hospitalized, not requiring supplemental oxygen
  4. Hospitalized, requiring any supplemental oxygen
  5. Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices
  6. Hospitalized, receiving invasive mechanical ventilation
  7. Death
28 days
change in C-Reactive Protein (CRP) levels
Time Frame: 5 Days
Change in C-Reactive protein (CRP) levels form enrollment (baseline) till 3 days followup to monitor inflammation
5 Days
change in interleukin 6 (IL-6)
Time Frame: 5 days
Change in IL-6 levels form enrollment (baseline) till 3 days followup
5 days
change in anti-SARS-CoV-2 antibody levels
Time Frame: 5 days
Change in IL-6 levels form enrollment (baseline) till 3 days followup by quantitive method
5 days
change in Horowitz idex
Time Frame: 28 days
The Horowitz index is a ratio used to assess lung function in patients during Hospital stay
28 days
change in radiological findings
Time Frame: 5 days
Change in any radiological after receive single Dose of C-IVIG
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Collaborators

Higher Education Commission (Pakistan)

Investigators

  • Principal Investigator: Shaukat Ali, PhD, Dow University of Health Sciences, Principal Dow College of Biotechnology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 2, 2022

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-IVIG-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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