NCT04891172

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Aug 2021

Typical duration for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2022

Completed
Last Updated

October 17, 2022

Status Verified

August 1, 2022

Enrollment Period

1.3 years

First QC Date

May 17, 2021

Last Update Submit

October 12, 2022

Conditions

Covid19

Keywords

COVID19 (Corona Virus Disease-2019)SARS-CoV-2 (Severe Acute respiratory syndrome Coronavirus 2)Passive immunizationIntravenous Immunoglobulin (IVIG)Pooled Convalescent PlasmaSevere ill COVID-19 patientsAntibodyAnti COVID 19 AntibodiesAnti SARS CoV 2 Antibodies

Outcome Measures

Primary Outcomes (1)

  • 28 day Mortality

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

    28 days

Secondary Outcomes (7)

  • Immediate and serious adverse event during hospital Stay

    28 days

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

    28 days

  • change in C-Reactive Protein (CRP) levels

    5 Days

  • change in interleukin 6 (IL-6)

    5 days

  • change in anti-SARS-CoV-2 antibody levels

    5 days

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

The Control group will be receive Standard of care only

C-IVIG

EXPERIMENTAL

The intervention group will receive the single dose of C-IVIG (0.15g/kg) with Standard of Care

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

Interventions

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

C-IVIG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

RECRUITING

Related Publications (6)

  • 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.

    PMID: 33138867BACKGROUND

  • 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.

    PMID: 33557591BACKGROUND

  • 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.

    PMID: 32283154BACKGROUND

  • 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.

    PMID: 33044747BACKGROUND

  • 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.

    PMID: 36700518DERIVED

  • 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.

    PMID: 36348476DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Shaukat Ali, PhD

    Dow University of Health Sciences, Principal Dow College of Biotechnology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaukat Ali, PhD

CONTACT

+92-3363010185ali.shaukat@duhs.edu.pk

Muneeba Sayeed, FCPS

CONTACT

+92-3002167826muneeba.sayeed@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 18, 2021

Study Start

August 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 2, 2022

Last Updated

October 17, 2022

Record last verified: 2022-08

Locations

PA(1)