Covid19NCT04769245
The Effectiveness of ACB-IP 1.0 Convalescent Plasma in COVID-19 Infection
An observational study of Covid19, run by Acibadem University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Feb 2021to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Multiple Organ Failure
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Acıbadem Labcell Cellular Therapy Laboratories
Istanbul, 34758
Ercument Ovalı, +905325729174, ercument.ovali@acibademlabcell.com.tr
- Recruiting
Acibadem Altunizade Hospital
Istanbul
Cansu Hemsinlioglu, MD
About this study
Official title: The Effectiveness of ACB-IP 1.0 Universal Pathogen Free Concentrated Cocktail Convalescent Plasma in COVID-19 Infection
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.
Read the 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.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
A mortality rate is a measure of the frequency of occurrence of death in a defined population during a specified interval.
Measured: 6 Months
Length of Hospitalization
The average length of stay in hospitals (ALOS) is often used as an indicator of efficiency
Measured: 6 Months
Secondary outcomes (1)
Side Effects
Problems that occur when treatment goes beyond the desired effect. Or problems that occur in addition to the desired therapeutic effect.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start18 Feb 2021
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Acıbadem Labcell
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769245
- Sponsor's protocol ID
- Acibadem Healthcare Group
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of ACB-IP 1.0 Universal Pathogen Free Concentrated Cocktail Convalescent Plasma in COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04769245
- Acronym / sponsor ID
- Acibadem Healthcare Group
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Acıbadem Labcell
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Multiple Organ Failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality Rate
Time frame: 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
Time frame: 6 Months
The average length of stay in hospitals (ALOS) is often used as an indicator of efficiency
1 secondary outcome
Side Effects
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Acibadem University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ercument Ovalı, MD (+905325729174, ercument.ovali@acibadem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Rate (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.