Covid19CORSAAR-AATNCT04799873
Alpha-1-Antitrypsin-Deficiency in COVID-19
An observational study of Covid19, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical course of patients that received AAT infusion for clinical indication is monitored. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Covid19
- What is being tested?
- AAT( Alpha 1 Antitrypsin)
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 8 Apr 2020to 1 Dec 2020
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All COVID-19 patients without need for invasive ventilation
Who may be able to join
- Infection with SARS-COV2
- Age over 18 years
Who cannot join
- Unability to consent
- Invasive ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual Treatment of COVID-19 by Application of Alpha-1-antitrypsin
The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical course of patients that received AAT infusion for clinical indication is monitored.
Read the detailed description
The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical course of patients that received AAT infusion for clinical indication is monitored. Clinical outcomes, blood inflammatory markers, and virus load are monitored.
- Conditions
- Covid19
- Being tested
- AAT( Alpha 1 Antitrypsin)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAT( Alpha 1 Antitrypsin)Drug
Also called AAT administration based on clinical indication
AAT administration based on clinical indication
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical course
Disease course such as death, need for ICU treatment, ventilatory support or deterioration are monitored
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start8 Apr 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Bals, Universität des Saarlandes
- Investigators
- Robert Bals, Principal investigator, UDS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799873
- Sponsor's protocol ID
- CORSAAR-AAT-001
- Acronym
- CORSAAR-AAT
- Status last verified
- May 2025
- First submitted
- 14 Mar 2021
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Treatment of COVID-19 by Application of Alpha-1-antitrypsin
- ClinicalTrials.gov ID
- NCT04799873
- Acronym / sponsor ID
- CORSAAR-AAT / CORSAAR-AAT-001
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 16 Mar 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.
The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical course of patients that received AAT infusion for clinical indication is monitored.
Detailed description
The blood concentrations of alpha-1-antitrypsin are monitored during COVID-19. The clinical course of patients that received AAT infusion for clinical indication is monitored. Clinical outcomes, blood inflammatory markers, and virus load are monitored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All COVID-19 patients without need for invasive ventilation
Key inclusion criteria (2 listed)
- Infection with SARS-COV2
- Age over 18 years
Key exclusion criteria (2 listed)
- Unability to consent
- Invasive ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAT( Alpha 1 Antitrypsin)Also: AAT administration based on clinical indicationAAT administration based on clinical indication | Drug | – |
Primary outcome
Clinical course
Time frame: 3 months
Disease course such as death, need for ICU treatment, ventilatory support or deterioration are monitored
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Robert Bals principal investigator
UDS
1 site 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 Universität des Saarlandes at 1 site in Germany.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical course (time frame: 3 months). 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 25 May 2025.