NCT04799873

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 8, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

March 14, 2021

Last Update Submit

May 21, 2025

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Clinical course

    Disease course such as death, need for ICU treatment, ventilatory support or deterioration are monitored

    3 months

Interventions

AAT( Alpha 1 Antitrypsin)DRUG

AAT administration based on clinical indication

Also known as: AAT administration based on clinical indication

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All COVID-19 patients without need for invasive ventilation

You may qualify if:

  • Infection with SARS-COV2
  • Age over 18 years

You may not qualify if:

  • Unability to consent
  • Invasive ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saarland University

Homburg, Saarland, 66421, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, RNA, DNA, EDTA plasma

MeSH Terms

Conditions

COVID-19

Interventions

alpha 1-antitrypsin-leukocyte elastase complex

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert Bals

    UDS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 16, 2021

Study Start

April 8, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations

DE(1)