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

NCT ID: NCT04769245

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-18

Study Completion Date

2021-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Covid19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acıbadem Labcell

OTHER

Sponsor Role collaborator

Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Acıbadem Labcell Cellular Therapy Laboratories

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Acibadem Altunizade Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ercument Ovalı, MD

Role: CONTACT

+905325729174

Cansu Hemsinlioglu

Role: CONTACT

+905356782771

Facility Contacts

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Ercument Ovalı

Role: primary

+905325729174

Cansu Hemsinlioglu, MD

Role: primary

Other Identifiers

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Acibadem Healthcare Group

Identifier Type: -

Identifier Source: org_study_id

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