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SARS-CoV-2 Antibodies Based IVIG Therapy for COVID-19 Patients

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04521309
Recruitment Status : Completed
First Posted : August 20, 2020
Last Update Posted : February 12, 2021
Sponsor:
Collaborator:
Higher Education Commission (Pakistan)
Information provided by (Responsible Party):
Dow University of Health Sciences

Study Description
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Brief Summary:
Severe and critically ill patients will be enrolled in the study (50 patients) after duly filled consent forms. Recipients shall be divided in to 5 groups with 10 patients per group to compare clinical efficacy and safety of patients in clinical phase I/phase II study. Each group shall receive particular single dose of Intravenously administered Immunoglobulins (IVIG) developed from convalescent plasma of recovered COVID-19 individual , an experimental drug along with standard treatment except for control group which will receive standard treatment only.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: SARS-CoV-2 antibody based IVIG therapy Phase 1 Phase 2

Detailed Description:

Passive immunization using intravenous immunoglobulins (IVIG) has been tested for treating previous viral outbreaks and holds the potential to save lives in the current crisis. Recently researchers from China reported satisfactory recovery of critically ill Corona Virus Disease 2019 (COVID 19) patients when high dose intravenous immunoglobulin (IVIG) were administered.

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. To evaluate safety of the formulation animal (rats) safety trials and survival of all the animals were observed.

It is intended to assess safety and efficacy of experimental the IVIG treatment in severe and critically ill COVID 19 patients through phase I/phase II randomized single blinded clinical trial with fifty study participants. FDA outlined criteria for passive immunization using convalescent plasma, which will be used for recruiting participants in the study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Antibodies Based Intravenous Immunoglobulin (IVIG) Therapy for Severe and Critically Ill COVID-19 Patients
Actual Study Start Date : June 19, 2020
Actual Primary Completion Date : January 26, 2021
Actual Study Completion Date : February 8, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Standard care only n = 10 patients.
Experimental: IVIG dose: 0.20 g/kg
Standard Care + Single dose of 0.20 g/Kg anti-COVID-19 IVIG (experimental drug prepared at DUHS) n= 10 patients
 Biological: SARS-CoV-2 antibody based IVIG therapy

Patient groups will receive IVIG prepared from pooled convalescent plasma from recovered COVID-19 patients. This will be administered sequentially and in varying dosages, infused over a period of 12 hours, intravenously.Additionally, all treatment groups will receive same standard care as control group. Standard Care as per hospital protocol, which may include:

Airway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic Support, Steroids, Painkillers, Anti-Pyretics
Experimental: IVIG dose: 0.25 g/kg
Standard Care + Single dose of 0.25 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients
 Biological: SARS-CoV-2 antibody based IVIG therapy

Patient groups will receive IVIG prepared from pooled convalescent plasma from recovered COVID-19 patients. This will be administered sequentially and in varying dosages, infused over a period of 12 hours, intravenously.Additionally, all treatment groups will receive same standard care as control group. Standard Care as per hospital protocol, which may include:

Airway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic Support, Steroids, Painkillers, Anti-Pyretics
Experimental: IVIG dose: 0.30 g/kg
Standard Care + Single dose of 0.30 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients
 Biological: SARS-CoV-2 antibody based IVIG therapy

Patient groups will receive IVIG prepared from pooled convalescent plasma from recovered COVID-19 patients. This will be administered sequentially and in varying dosages, infused over a period of 12 hours, intravenously.Additionally, all treatment groups will receive same standard care as control group. Standard Care as per hospital protocol, which may include:

Airway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic Support, Steroids, Painkillers, Anti-Pyretics
Experimental: IVIG dose: 0.35 g/kg
Standard Care + Single dose of 0.35 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients
 Biological: SARS-CoV-2 antibody based IVIG therapy

Patient groups will receive IVIG prepared from pooled convalescent plasma from recovered COVID-19 patients. This will be administered sequentially and in varying dosages, infused over a period of 12 hours, intravenously.Additionally, all treatment groups will receive same standard care as control group. Standard Care as per hospital protocol, which may include:

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


Outcome Measures
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Primary Outcome Measures :
  1. 28 Days mortality [ Time Frame: 28 days ]
    All cause mortality of participants will be monitored for 28 days to assess the safety and efficacy of IVIG treatment.

  2. Requirement of supplemental oxygen support [ Time Frame: 28 days ]
    Number of days required for invasive or non-invasive oxygen supply during hospital stay as per oxygen saturation status of patient

  3. Number of days on assisted ventilation [ Time Frame: 28 days ]
    Number of days a participant will be requiring assisted ventilation both invasive and noninvasive

  4. Days to step down [ Time Frame: 28 days ]
    Shifting from ICU to ward

  5. Days to Hospital Discharge [ Time Frame: 28 days ]
    Duration from day of enrollment in study to Day of hospital discharge

  6. Adverse events during hospital stay [ Time Frame: 28 days ]
    Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)

  7. Change in C-Reactive Protein (CRP) levels [ Time Frame: 28 days ]
    Change in C-Reactive Protein (CRP) levels from baseline will be used to monitor inflammation

  8. Change in neutrophil lymphocyte ratio [ Time Frame: 28 days ]
    change in neutrophil lymphocyte ratio from baseline will be used to monitor inflammation


Secondary Outcome Measures :
  1. Change in Ferritin levels [ Time Frame: 28 days ]
    change in Ferritin level from baseline will be used to monitor inflammation and immune dysregulation

  2. Change in lactate dehydrogenase (LDH) levels [ Time Frame: 28 days ]
    change in LDH from baseline will be used to monitor infections and tissue health

  3. Change in radiological (X-ray) findings [ Time Frame: 28 days ]
    Any change seen in radiological chest X-ray findings

  4. Days to negative SARS-CoV-2 Polymerase Chain Reaction (PCR) test [ Time Frame: 28 days ]
    Time taken for participant to receive negative COVID-19 PCR test

  5. Anti-SARS-CoV-2 Antibody [ Time Frame: 28 days ]
    Anti-SARS-CoV-2 antibody titre from blood measured by semi-qualitative method

  6. Change in fever [ Time Frame: 28 days ]
    Change in body temperature from baseline will be used to monitor safety and efficacy

  7. Change in Sodium levels [ Time Frame: 28 days ]
    Change in electrolytes (Sodium) seen in participants

  8. Change in Potassium levels [ Time Frame: 28 days ]
    Change in electrolytes (Potassium) seen in participants

  9. Change in Chloride levels [ Time Frame: 28 days ]
    Change in electrolytes (Chloride) seen in participants

  10. Change in Bicarbonate levels [ Time Frame: 28 days ]
    Change in electrolytes (Bicarbonate) seen in participants


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Above 18 years of age
  • Have positive SARS-CoV-2 PCR on nasopharyngeal and/or oropharyngeal swabs
  • Admitted in isolation ward and ICU of institutes affiliated with DUHS
  • have severe or critical COVID 19 as judged by the treating physician
  • Consent given by the patient or first degree relative

Exclusion Criteria:

  • Pregnancy
  • Previous allergic reaction to immunoglobulin treatment
  • Ig A deficiency
  • Patient requiring 2 inotropic agents to maintain blood pressures
  • Known case of any autoimmune disorder
  • Acute kidney injury or chronic renal failure
  • Known case of thromboembolic disorder
  • Aseptic meningitis
Contacts and Locations
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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): NCT04521309


Locations
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Pakistan
Dow University of Health Sciences
Karachi, Sindh, Pakistan, 74200
Sponsors and Collaborators
Dow University of Health Sciences
Higher Education Commission (Pakistan)
Investigators
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Principal Investigator: Dr.Shaukat Ali, PhD Dow University of Health Sciences, Principal Dow College of Biotechnology
  Study Documents (Full-Text)

Documents provided by Dow University of Health Sciences:
Study Protocol  [PDF] April 30, 2020

More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT04521309    
Other Study ID Numbers: biotech001
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 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
Keywords provided by Dow University of Health Sciences:
COVID19 ( Corona Virus Disease -2019)
SARS-CoV-2 (Severe Acute respiratory syndrome Coronavirus 2)
Passive Immunization
Intravenous Immunoglobulin (IVIG)
 Pooled convalescent Plasma
Critically ill COVID-19 patients
Severe COVID-19 patients
Antibody
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
 Respiratory Tract Infections
Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs