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COVID-19NCT07051967

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

An observational study of COVID-19 and Acute Respiratory Distress Syndrome Due to COVID-19, run by Charite University, Berlin, Germany at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
40 participants
Where
1 siteGermany
Study dates
22 Sep 2025to 30 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Claudia Spies, MD Prof. contact

+49 30 450 551102

claudia.spies@charite.de

Germany1 site, 1 recruiting
  • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

    Berlin, 13353

    Claudia Spies, MD. Prof., +49 30 450 55 11 02, claudia.spies@charite.de

    Claudia Spies, MD, Prof.

    Recruiting

Other trials in Germany

About this study

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.

Read the detailed description

This is a retrospective comparison of approximately 13 pregnant patients and approximately 27 non-pregnant patients who developed respiratory failure (also known as acute respiratory distress syndrome, or ARDS) due to COVID-19 infection. The analysis is based on routine treatment data from the Post-Intensive Care Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), as well as intensive care treatment data, primarily from the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK). In some cases, additional data were obtained from the Medical Clinic for Nephrology and Internal Intensive Care Medicine (CCM/CVK/CBF), the Medical Clinic specializing in Hepatology and Gastroenterology (CCM/CVK), and the Department of Infectiology, Pulmonology, and Intensive Care Medicine (CCM).

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 groups in NCT07051967
Study groupRoleWhat they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 27.03.2020-06.05.2024

Secondary outcomes (37)
  1. Catecholamine therapy

    Catecholamine therapy during intensive care unit (ICU) treatment is measured in doses and duration.

    Measured: 27.03.2020-06.05.2024

  2. Extracorporeal Membrane Oxygenation treatment

    Extracorporeal Membrane Oxygenation treatment in the ICU Yes or No

    Measured: 27.03.2020-06.05.2024

  3. Need for ventilation during ICU treatment

    Need for ventilation during ICU treatment and, if so, ventilation route (non-invasive and invasive, endotracheal tube and tracheostomy tube) and duration of ventilation

    Measured: 27.03.2020-06.05.2024

  4. Duration of ventilation during ICU treatment

    Duration of ventilation during ICU treatment is measured in hours

    Measured: 27.03.2020-06.05.2024

  5. Oxygenation index

    Oxygenation index/Horowitz index is defined as the ratio of the arterial partial pressure of oxygen (PaO₂, in mmHg) to the fraction of inspired oxygen (FiO₂, expressed as a decimal).

    Measured: 27.03.2020-06.05.2024

  6. Severity of illness

    Severity of illness during ICU treatment is assessed with validated intensive care unit scores.

    Measured: 27.03.2020-06.05.2024

  7. Incidence of delirium

    Incidence of delirium in the ICU is measured with validated delirium scores.

    Measured: 27.03.2020-06.05.2024

  8. Duration of delirium

    Duration of delirium in the ICU is measured in days

    Measured: 27.03.2020-06.05.2024

  9. Sedation Medications

    Kind of medications required for sedation.

    Measured: 27.03.2020-06.05.2024

  10. Sedation dosage

    The amount of drug required for sedation.

    Measured: 27.03.2020-06.05.2024

  11. Duration of sedation

    Duration of sedation is measured in days.

    Measured: 27.03.2020-06.05.2024

  12. Depth of sedation

    Depth of sedation during ICU treatment

    Measured: 27.03.2020-06.05.2024

  13. Continuous muscle relaxation

    Continuous muscle relaxation during ICU treatment

    Measured: 27.03.2020-06.05.2024

  14. Vaccination status

    Vaccination status at the start of ICU treatment

    Measured: 27.03.2020-06.05.2024

  15. COVID-19-specific immunotherapy

    COVID-19-specific immunotherapy (e.g., tocilizumab, dexamethasone, baricitinib) during ICU treatment

    Measured: 27.03.2020-06.05.2024

  16. Type of Anti-infective therapy

    Type of anti-infective therapy during ICU treatment

    Measured: 27.03.2020-06.05.2024

  17. Duration of Anti-infective therapy

    Duration of anti-infective therapy during ICU treatment is measured in days.

    Measured: 27.03.2020-06.05.2024

  18. Week of pregnancy

    Week of pregnancy during ICU treatment in the pregnant women group

    Measured: 27.03.2020-06.05.2024

  19. Need for a cesarean section

    Need for a cesarean section in the pregnant women group, yes or no.

    Measured: 27.03.2020-06.05.2024

  20. Organ complications

    Organ complications, including bleeding and pregnancy complications during hospital treatment. Data from patient records.

    Measured: 27.03.2020-06.05.2024

  21. Nutrition

    Nutrition (enteral vs. parenteral) during ICU treatment

    Measured: 27.03.2020-06.05.2024

  22. Dialysis 1

    Dialysis during ICU treatment (binary)

    Measured: 27.03.2020-06.05.2024

  23. Dialysis 2

    Dialysis during ICU treatment (duration)

    Measured: 27.03.2020-06.05.2024

  24. Intensive care unit mortality

    Data from patient records

    Measured: 27.03.2020-06.05.2024

  25. Hospital mortality

    Data from patient records

    Measured: 27.03.2020-06.05.2024

  26. 90-day mortality

    Data from patient records

    Measured: 27.03.2020-06.05.2024

  27. 180-day mortality

    Data from patient records

    Measured: 27.03.2020-06.05.2024

  28. Intensive care unit length of stay

    Participants are followed up for the duration of intensive care unit stay, an expected average of 2 days

    Measured: 27.03.2020-06.05.2024

  29. Duration of Hospital stay

    Participants are followed up for the duration of hospital stay, an expected average of 7 days

    Measured: 27.03.2020-06.05.2024

  30. Grip strength Test

    Grip strength at the time of presentation to the PICS outpatient clinic is measured with a dynamometer.

    Measured: 27.03.2020-06.05.2024

  31. Mobility

    Mobility at the time of presentation to the PICS outpatient clinic is measured with the Timed Up-and-Go (TUG).

    Measured: 27.03.2020-06.05.2024

  32. Cognition 1

    Cognition 1 at the time of presentation to the PICS outpatient clinic is measured with the MiniCog. The MiniCog consists of two items, the word recall test and the clock-drawing test. Performance in these test is rated on a scale ranging from 0 - 5, with <3 points indicating a suspicion of dementia.

    Measured: 27.03.2020-06.05.2024

  33. Cognition 2

    Cognition 2 at the time of presentation to the PICS outpatient clinic is measured with the Animal Naming Test

    Measured: 27.03.2020-06.05.2024

  34. Mental health

    Mental health at the time of presentation to the PICS outpatient clinic is measured with Patient Health Questionnaire-4 (It comprises the first two questions of the depression module of the PHQ-D [PHQ-2] and the first two questions of the module for assessing generalized anxiety [GAD-2]) and patient questionnaire with subjective patient assessment.

    Measured: 27.03.2020-06.05.2024

  35. PBQ Parent-Child Relationship Questionnaire

    PBQ at the time of presentation to the PICS outpatient clinic. This questionnaire is a 25-question self-completion questionnaire, which was developed in order to recognize disorders in the mother-child relationship at an early stage.

    The questionnaire is made up of 4 scales. Scale 1 Delayed attachment cut-off 12, Scale 2 Rejection and anger cut-off 17, Scale 3 Anxiety cut-off 10 and Scale 4 Risk of child abuse cut-off 3.

    Measured: 27.03.2020-06.05.2024

  36. Edinburgh Postpartum Depression Questionnaire (EPDS)

    The Edinburgh Postnatal Depression Scale (EDPS) was developed to identify women who may have postpartum depression. Each answer is given a score of 0 to 3 .The maximum score is 30. A score of more than 10 suggests minor or major depression may be present.

    Measured: 27.03.2020-06.05.2024

  37. Health-related quality of life

    Health-related quality of life at the time of presentation to the PICS outpatient clinic is measured with EQ-5D-5L questionnaire. Higher Score indicate better Healt-related quality of life.

    Measured: 27.03.2020-06.05.2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2025
  2. Study start22 Sep 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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
Retrospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07051967
Sponsor's protocol ID
CovPreg
Status last verified
Sep 2025
First submitted
3 Jul 2025
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Acute Respiratory Distress Syndrome Due to COVID-19, run by Charite University, Berlin, Germany 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 5 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: looking for participants now, as of the sponsor's last update on 25 Sep 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claudia Spies, MD Prof. (+49 30 450 551102, claudia.spies@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impairment in at least one PICS domain (mobility, cognition, and/or mental health) (time frame: 27.03.2020-06.05.2024). 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 Sep 2025.

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