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Covid19Phase 2/3NCT04891172

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

A Phase 2/3 study testing Anti COVID 19 Intravenous Immunoglobulin (C-IVIG) in people with Covid19, run by Dow University of Health Sciences at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 patients in Clinical Trial phase II/III. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
1 sitePakistan
Study dates
1 Aug 2021to 2 Dec 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Shaukat Ali, PhD contact

+92-3363010185

ali.shaukat@duhs.edu.pk

Muneeba Sayeed, FCPS contact

+92-3002167826

muneeba.sayeed@yahoo.com

Pakistan1 site, 1 recruiting

  • Dow University of Health Sciences

    Karachi, Sindh, 74200

    Prof. Dr. Mohammed Saeed Quraishy, FRCS, FCPS, +91-03008240234, vc@duhs.edu.pk

    Dr. Shaukat Ali, PhD, +91-03363010185, ali.shaukat@duhs.edu.pk

    Recruiting

Other trials in Pakistan

About this study

Official title: 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

Read the 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

Conditions
Covid19
Being tested
Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)
Keywords
COVID19 (Corona Virus Disease-2019), SARS-CoV-2 (Severe Acute respiratory syndrome Coronavirus 2), Passive immunization, Intravenous Immunoglobulin (IVIG), Pooled Convalescent Plasma, Severe ill COVID-19 patients, Antibody, Anti COVID 19 Antibodies, Anti SARS CoV 2 Antibodies
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)Biological

    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

Study groups in NCT04891172
Study groupRoleWhat they receive
ControlNo interventionThe Control group will be receive Standard of care only
C-IVIGExperimentalThe intervention group will receive the single dose of C-IVIG (0.15g/kg) with Standard of Care
Receives: Biological: Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28 day Mortality

    All cause mortality of participants will be monitored for 28 days to asses the safety and efficacy of C-IVIG

    Measured: 28 days

Secondary outcomes (7)

  1. Immediate and serious adverse event during hospital Stay

    Immediate adverse event (within 24 hours) and serious adverse event (throughout the hospital stay) which will be observed

    Measured: 28 days

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

    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

    Measured: 28 days

  3. change in C-Reactive Protein (CRP) levels

    Change in C-Reactive protein (CRP) levels form enrollment (baseline) till 3 days followup to monitor inflammation

    Measured: 5 Days

  4. change in interleukin 6 (IL-6)

    Change in IL-6 levels form enrollment (baseline) till 3 days followup

    Measured: 5 days

  5. change in anti-SARS-CoV-2 antibody levels

    Change in IL-6 levels form enrollment (baseline) till 3 days followup by quantitive method

    Measured: 5 days

  6. change in Horowitz idex

    The Horowitz index is a ratio used to assess lung function in patients during Hospital stay

    Measured: 28 days

  7. change in radiological findings

    Change in any radiological after receive single Dose of C-IVIG

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2021
  2. Study start1 Aug 2021
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion2 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04891172
Sponsor's protocol ID
C-IVIG-02
Status last verified
Aug 2022
First submitted
17 May 2021
Last updated
17 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ali S, Luxmi S, Anjum F, Muhaymin SM, Uddin SM, Ali A, Ali MR, Tauheed S, Khan M, Bajwa M, Baig SU, Shalim E, Ahmed I, Khan AS, Quraishy S. Hyperimmune anti-COVID-19 IVIG (C-IVIG) Therapy for Passive Immunization of Severe and Critically Ill COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Nov 2;21(1):905. doi: 10.1186/s13063-020-04839-5.

    PubMed 33138867

  • Ali S, Uddin SM, Ali A, Anjum F, Ali R, Shalim E, Khan M, Ahmed I, M Muhaymin S, Bukhari U, Luxmi S, Khan AS, Quraishy S. Production of hyperimmune anti-SARS-CoV-2 intravenous immunoglobulin from pooled COVID-19 convalescent plasma. Immunotherapy. 2021 Apr;13(5):397-407. doi: 10.2217/imt-2020-0263. Epub 2021 Feb 9.

    PubMed 33557591

  • Xie Y, Cao S, Dong H, Li Q, Chen E, Zhang W, Yang L, Fu S, Wang R. Effect of regular intravenous immunoglobulin therapy on prognosis of severe pneumonia in patients with COVID-19. J Infect. 2020 Aug;81(2):318-356. doi: 10.1016/j.jinf.2020.03.044. Epub 2020 Apr 10. No abstract available.

    PubMed 32283154

  • Chai KL, Valk SJ, Piechotta V, Kimber C, Monsef I, Doree C, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2020 Oct 12;10:CD013600. doi: 10.1002/14651858.CD013600.pub3.

    PubMed 33044747

  • Kimber C, Valk SJ, Chai KL, Piechotta V, Iannizzi C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Hyperimmune immunoglobulin for people with COVID-19. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD015167. doi: 10.1002/14651858.CD015167.pub2.

    PubMed 36700518

  • Ali S, Shalim E, Farhan F, Anjum F, Ali A, Uddin SM, Shahab F, Haider M, Ahmed I, Ali MR, Khan S, Rao S, Guriro K, Elahi S, Ali M, Mushtaq T, Sayeed MA, Muhaymin SM, Luxmi S, Saifullah, Qureshi S. Phase II/III trial of hyperimmune anti-COVID-19 intravenous immunoglobulin (C-IVIG) therapy in severe COVID-19 patients: study protocol for a randomized controlled trial. Trials. 2022 Nov 8;23(1):932. doi: 10.1186/s13063-022-06860-2.

    PubMed 36348476

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Anti COVID 19 Intravenous Immunoglobulin (C-IVIG) in people with Covid19, run by Dow University of Health Sciences at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shaukat Ali, PhD (+92-3363010185, ali.shaukat@duhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28 day Mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04891172, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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