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

Sponsor

Acibadem University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04769245

Collaborator

Acıbadem Labcell (Other)

Enrollment

Locations

3.4

Anticipated Duration (Months)

Patients Per Site

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 18, 2021

Anticipated Primary Completion Date :

Apr 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Single donor convalescent plasma Patients who had positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) for SARS-CoV2 and radiologically confirmed pneumonia treated with single donor plasma
ACB- IP 1.0 Patients who had positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) for SARS-CoV2 and radiologically confirmed pneumonia treated with ACB- IP 1.0 pathogen-free concentrated cocktail convalescent plasma

Outcome Measures

Primary Outcome Measures

Mortality Rate [6 Months]
A mortality rate is a measure of the frequency of occurrence of death in a defined population during a specified interval.
Length of Hospitalization [6 Months]
The average length of stay in hospitals (ALOS) is often used as an indicator of efficiency

Secondary Outcome Measures

Side Effects [6 Months]
Problems that occur when treatment goes beyond the desired effect. Or problems that occur in addition to the desired therapeutic effect.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acıbadem Labcell Cellular Therapy Laboratories	Istanbul		Turkey	34758
2	Acibadem Altunizade Hospital	Istanbul		Turkey

Sponsors and Collaborators

Acibadem University
Acıbadem Labcell

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Acibadem University

ClinicalTrials.gov Identifier:

NCT04769245

Other Study ID Numbers:

Acibadem Healthcare Group

First Posted:

Feb 24, 2021

Last Update Posted:

Feb 24, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Feb 24, 2021