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NCT Number: NCT04521309

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SARS-CoV-2 antibody based IVIG therapy

Biological

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Collaborators

  • Higher Education Commission (Pakistan)

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2020
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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