Anti COVID 19 Hyperimmune Intravenous Immunoglobulin (C-IVIG) Therapy for Severe COVID-19 Patients
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- STATUS
- Recruiting
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- days left to enroll
- 35
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- participants needed
- 310
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- sponsor
- Dow University of Health Sciences
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
Description
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. Phase I/II trial was completed and shown potential safety and efficacy of the drug Anti COVID 19 intravenous immunoglobulin (C-IVIG) in severe and critical patient of COVID 19.
This trial aim is to investigate the safety and efficacy of passive immunization in severe COVID 19 patients in phase II/III. The trial will be randomized, single-blinded, superiority trial, through parallel-group design. The participant will be either to receive C-IVIG with Standard of care or Placebo with Standard of care. The study will be consist of 310 participant in which 155 will receive single dose of C-IVIG (0.15g/kg) with standard of care and 155 will receive placebo with 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 anti-pyretic.
Randomized test patients will receive single dose of C-IVIG in 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: placebo with standard hospital care only
Details
| Condition | COVID19 |
|---|---|
| Treatment | Anti COVID 19 Intravenous Immunoglobulin (C-IVIG) |
| Clinical Study Identifier | NCT04891172 |
| Sponsor | Dow University of Health Sciences |
| Last Modified on | 30 August 2021 |
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