Trial intelligence / Profile preview

C-IVIG for Severe and Critically Ill COVID-19

NCT04521309Phase 2

Key facts

Status: Completed
Start: Jun 2020
Primary completion: Jan 2021
Countries: 1
Sponsor: Dow University of Health Sciences
Modality: Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies

Drugs: Anti-COVID-19 intravenous immunoglobulin
Conditions: coronavirus disease 2019 (COVID-19)

Overview

Phase 2, randomised, single-blind trial of Anti-COVID-19 intravenous immunoglobulin in coronavirus disease 2019 (COVID-19) (5 arms), sponsored by Dow University of Health Sciences. Primary endpoints: 28 Days mortality, Requirement of supplemental oxygen support at 28 days and 6 more. Started Jun 2020; status: completed.

Design

5 arms

Study design: RandomizedSingle-blind

Control
Standard Care only
IVIG 0.15 g/kg
Standard Care + Single dose 0.15 g/kg C-IVIG
IVIG 0.20 g/kg
Standard Care + Single dose 0.20 g/kg C-IVIG
IVIG 0.25 g/kg
Standard Care + Single dose 0.25 g/kg C-IVIG
IVIG 0.30 g/kg
Standard Care + Single dose 0.30 g/kg C-IVIG

Endpoints

Primary

28 Days mortality28 days
Requirement of supplemental oxygen support28 days
Number of days on assisted ventilation28 days
Days to step down28 days
Days to Hospital Discharge28 days

Secondary

Change in Ferritin levels28 days
Change in lactate dehydrogenase levels28 days
Change in radiological (X-ray) findings28 days
Days to negative SARS-CoV-2 Polymerase Chain Reaction (PCR) test28 days
Anti-SARS-CoV-2 Antibody28 days
Change in fever28 days
Change in Sodium levels28 days
Change in Potassium levels28 days

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