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Intravenous Immunoglobulins for the Treatment of Covid-19 Patients: a Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04548557
Recruitment Status : Not yet recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Collaborators:
University of Lahore
Amson Vaccine and Pharma (Pvt) Limited
Information provided by (Responsible Party):
Prof. Dr. Fridoon Jawad Ahmad, University of Health Sciences Lahore

Brief Summary:
The current project is based on the immunological studies covering the potential of disease induced immunoglobulins as treatment regime. We would be able to generate the concentrated antibodies specific against coronavirus (Covid-19). These antibodies can be used as serum therapy. Aside from a Covid-19 vaccine, antibodies from recovered patients could provide a short-term "passive immunization" to the disease. Those antibodies can be extracted from the blood serum of surviving patients and then injected into infected people. Passive immunization usually lasts for a few weeks or months, after which those borrowed or donated antibodies, get broken down by the host body within about 30 days. While drugs to treat patients with covid-19, and vaccines to prevent infection are being developed, a fast acting, stopgap serum therapy could be useful as a first aid for high-risk patients.

Condition or disease Intervention/treatment Phase
Covid19 Biological: intravenous immunoglobulin therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: one group in conventional with routine therapy and interventional group will receive intravenous immunoglobulin therapy
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Immunoglobulins for the Treatment of Covid-19 Patients: a Clinical Trial
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
They will not receive any intervention
Experimental: IVIG group
They will reveive intravenous immunoglobulin therapy
Biological: intravenous immunoglobulin therapy
It is passive immunization therapy. Plasma therapy is subjected to moderate to severe patients specially, while all effected individuals can take benefit of immunoglobulin therapy because dose of immunoglobulins can be controlled




Primary Outcome Measures :
  1. In hospital days [ Time Frame: 14 days or discharge ]
    total number of days the patient remain in hospital

  2. 14 day mortality [ Time Frame: 14 days ]
    mortality if any in the study duration of 14 days


Secondary Outcome Measures :
  1. D-dimers [ Time Frame: 7 days ]
    reduction in D-dimers (< 250 ng/mL)

  2. C-reactive protein [ Time Frame: 7 days ]
    reduction in C-Reactive protein (less than 10 mg/L)

  3. Oxygen saturation [ Time Frame: 7 days ]
    improvement in oxygen saturation (pulse oximeter readings within range of 95 to 100%)

  4. TNF alpha [ Time Frame: 7 days ]
    reduction in TNF alpha after IVIG treatment (upto 8.1 pg/mL)

  5. IL-6 [ Time Frame: 7 days ]
    reduction in IL-6 after IVIG treatment

  6. Ferritin [ Time Frame: 7 days ]
    reduction in ferritin levels after IVIG treatment

  7. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 14 days ]
    safety and tolerability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 18 yrs
  • Both genders
  • Lab Confirmed COVID-19 infection by PCR or plasma positive of specific antibody against COVID-19
  • In hospital treatment ≥ 72 hours
  • Admitted patients
  • Mild to moderately severe patients

Exclusion Criteria:

  • Exist of other evidences that can explain pneumonia including but not limited to influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia, noninfectious causes, etc.
  • Patients with respiratory diseases other than Covid-19 infection
  • Pregnant and breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548557


Contacts
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Contact: riffat mehboob, Ph.D +923313380909 mehboob.riffat@gmail.com
Contact: Fridoon J Ahmad, Ph.D

Locations
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Pakistan
University of Health Sciences
Lahore, Punjab, Pakistan, 54000
Contact: Riffat o Mehboob, PhD       mehboob.riffat@gmail.com   
Contact: Fridoon Jawad Ahmad, PhD         
Principal Investigator: Fridoon Jawad Ahmad, PhD         
Sub-Investigator: Javed Akram, MBBS,FRCS,MRCP         
Sub-Investigator: Riffat Mehboob, PhD         
Sub-Investigator: Syed Amir Gilani, PhD         
Sub-Investigator: Muhammad Akram Tariq, PhD         
Sub-Investigator: Gibran Sheikh, PhD         
Sub-Investigator: Hassan Ahmad Khan, M.Phil         
Sponsors and Collaborators
University of Health Sciences Lahore
University of Lahore
Amson Vaccine and Pharma (Pvt) Limited
Investigators
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Study Chair: Javed Akram, MBBS,FRCP,MRCP Saglik Bilimleri Universitesi
Principal Investigator: Fridoon J Ahmad, Ph.D Saglik Bilimleri Universitesi
Publications:

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Responsible Party: Prof. Dr. Fridoon Jawad Ahmad, Professor,, University of Health Sciences Lahore
ClinicalTrials.gov Identifier: NCT04548557    
Other Study ID Numbers: UniversityHSL-IVIG
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Prof. Dr. Fridoon Jawad Ahmad, University of Health Sciences Lahore:
Covid 19
intravenous immunogloulin therapy
passive immunization
Additional relevant MeSH terms:
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Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs