Post-intensive Care Syndromes in Pregnant Patients With Respiratory Failure and COVID-19 Compared to Non-pregnant Patients With Respiratory Failure and COVID-19

NCT07051967 | Recruiting

• 1 other identifier: CovPreg
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to characterize patients in the Post-Intensive-Care-Syndrome (PICS) outpatient clinic based on routine data and to evaluate their treatment outcome over the course of their treatment. For this purpose, data sets from approx. 40 patients who were treated in the intensive care unit subsequently evaluated in the PICS outpatient clinic between March 27, 2020, and May 6, 2024, will be analyzed.

Conditions

COVID-19; Acute Respiratory Distress Syndrome Due to COVID-19; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Impairment in at least one PICS domain (mobility, cognition, and/or mental health)

  Impairment in at least one PICS domain (mobility, cognition, and/or mental health) after discharge from the ICU, assessed at the time of presentation to the PICS outpatient clinic. The planned PICS outpatient presentation takes place 3 and 6 months (ranging from 1 month to 3 years) after the initial ICU stay.

  27.03.2020-06.05.2024

Secondary Outcomes (37)

• Catecholamine therapy

  27.03.2020-06.05.2024

• Extracorporeal Membrane Oxygenation treatment

  27.03.2020-06.05.2024

• Need for ventilation during ICU treatment

  27.03.2020-06.05.2024

• Duration of ventilation during ICU treatment

  27.03.2020-06.05.2024

• Oxygenation index

  27.03.2020-06.05.2024

Study Arms (2)

Female pregnant patients with COVID-19 related Acute respiratory distress syndrome

* Pregnancy at the time of initial hospital admission (not necessarily at the time of transfer to Charité - Universitätsmedizin Berlin). * Age: 18 years and older * Admission to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine between March 27, 2020 and May 6, 2024. * COVID-19 infection in temporal association with the intensive care unit admission. * Intensive care unit admission with lung failure or development of lung failure in the course of intensive care unit treatment. * Admission to the intensive care unit with lung failure or development of lung failure during intensive care unit stay

Female non-pregnant patients with COVID-19 related Acute respiratory distress syndrome

* No pregnancy at the time of admission. * Age: 18 years and older * Admission to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine between March 27, 2020 and May 6, 2024. * COVID-19 infection in temporal association with the intensive care unit admission. * Intensive care unit admission with lung failure or development of lung failure in the course of intensive care unit treatment. * Admission to the intensive care unit with lung failure or development of lung failure during intensive care unit stay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult female pregnant and non-pregnant patients who were admitted to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine, Charité - Universitaetsmedizin Berlin between March 27, 2020 and May 6, 2024.

You may qualify if:

• Age: 18 years and older
• Admission to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine between March 27, 2020 and May 6, 2024.
• COVID-19 infection in temporal assocoation with the intensive care unit admission.
• Intensive care unit admission with lung failure or development of lung failure in the course of intensive care unit treatment.
• Admission to the intensive care unit with lung failure or development of lung failure during intensive care unit stay.

You may not qualify if:

• Gender: Male
• Diagnosis: Non-COVID or no respiratory failure

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Central Study Contacts

Claudia Spies, MD Prof.

CONTACT

+49 30 450 551102; claudia.spies@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitaetsmedizin Berlin

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 4, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

DE (1)