Anti COVID 19 Hyperimmune Intravenous Immunoglobulin (C-IVIG) Therapy for Severe COVID-19 Patients
NCT ID: NCT04891172
Last Updated: 2022-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
310 participants
INTERVENTIONAL
2021-08-01
2022-12-02
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
The Control group will be receive Standard of care only
No interventions assigned to this group
C-IVIG
The intervention group will receive the single dose of C-IVIG (0.15g/kg) with Standard of Care
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Higher Education Commission (Pakistan)
OTHER
Dow University of Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Shaukat Ali, PhD
Role: PRINCIPAL_INVESTIGATOR
Dow University of Health Sciences, Principal Dow College of Biotechnology
Locations
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Dow University of Health Sciences
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol: Protocol00
Other Identifiers
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C-IVIG-02
Identifier Type: -
Identifier Source: org_study_id
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