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NCT04769245 Clinical Trial

The Effectiveness of ACB-IP 1.0 Convalescent Plasma in COVID-19 Infection

Covid19 Clinical Trial

Official title:
The Effectiveness of ACB-IP 1.0 Universal Pathogen Free Concentrated Cocktail Convalescent Plasma in COVID-19 Infection

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04769245
Other study ID # Acibadem Healthcare Group
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 18, 2021
Est. completion date June 1, 2021

Study information
Verified date February 2021
Source Acibadem University
Contact Ercument Ovali, MD
Phone +905325729174
Email ercument.ovali@acibadem.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pathogen-free, concentrated, pooled convalescent plasma has higher SARS-CoV2 antibody titers and neutralizing antibody activities, without requiring blood group compatibility that allows patient accessibility in a shorter time and has safe plasma characteristic.

Description:

The efficacy of SARS-CoV2 standard single donor convalescent plasma varied according to the application time and most importantly the amount of antibody that is administered. Single donor plasma has some drawbacks; such as the insufficient levels of neutralizing antibody activities, the requirements of blood group compatibility, and the risk of infection transmission. In this study, the efficacy and safety of pathogen inactivated, isohemagglutinin-depleted (concentrated) and pooled convalescent plasma was investigated.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date June 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Are over the age of 60 or- - Between the ages of 18-60, serious comorbidities (cancer, COPD, cardiovascular illness, hypertension, DM) - Clinically diagnose COVID-19 or radiological diagnosed COVID-19 pnemonia Exclusion Criteria: - Multiple Organ Failure

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Acibadem Altunizade Hospital Istanbul
Turkey Acibadem Labcell Cellular Therapy Laboratories Istanbul

Sponsors (2)
Lead Sponsor Collaborator
Acibadem University Acibadem Labcell

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Rate A mortality rate is a measure of the frequency of occurrence of death in a defined population during a specified interval. 6 Months
Primary Length of Hospitalization The average length of stay in hospitals (ALOS) is often used as an indicator of efficiency 6 Months
Secondary Side Effects Problems that occur when treatment goes beyond the desired effect. Or problems that occur in addition to the desired therapeutic effect. 6 Months
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