NCT04769245

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

1 month

First QC Date

February 15, 2021

Last Update Submit

February 23, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Length of Hospitalization

    The average length of stay in hospitals (ALOS) is often used as an indicator of efficiency

    6 Months

Secondary Outcomes (1)

  • Side Effects

    6 Months

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) for SARS-CoV2 and/or radiologically confirmed pneumonia, were included in the study.

You may qualify if:

  • 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

You may not qualify if:

  • Multiple Organ Failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Acıbadem Labcell Cellular Therapy Laboratories

Istanbul, 34758, Turkey (Türkiye)

RECRUITING

Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Cansu Hemsinlioglu

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 24, 2021

Study Start

February 18, 2021

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations