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

Phase 2

• Conditions: Covid19
• Interventions: Biological: Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)

• Registration Number: NCT04891172
• Lead Sponsor: Dow University of Health Sciences

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

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

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Study Start: 2021-08-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-17
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

1. Above 18 years of age
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

1. Critical COVID-19 patients [ non-invasive ventilation (HFNC, BiPAP, CPAP) and invasive ventilation],
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C-IVIG	Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)	The intervention group will receive the single dose of C-IVIG (0.15g/kg) with Standard of Care

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change in interleukin 6 (IL-6)	5 days	Change in IL-6 levels form enrollment (baseline) till 3 days followup
Immediate and serious adverse event during hospital Stay	28 days	Immediate adverse event (within 24 hours) and serious adverse event (throughout the hospital stay) which will be observed
change in C-Reactive Protein (CRP) levels	5 Days	Change in C-Reactive protein (CRP) levels form enrollment (baseline) till 3 days followup to monitor inflammation
Clinical Status of follow-up days according to 7-Catergory Ordinal Scale	28 days	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
change in radiological findings	5 days	Change in any radiological after receive single Dose of C-IVIG
change in anti-SARS-CoV-2 antibody levels	5 days	Change in IL-6 levels form enrollment (baseline) till 3 days followup by quantitive method
change in Horowitz idex	28 days	The Horowitz index is a ratio used to assess lung function in patients during Hospital stay

Trial Locations

Locations (1)

Dow University of Health Sciences; 🇵🇰 Karachi, Sindh, Pakistan