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.
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
- Conditions the study is for
- COVID-19, Acute Respiratory Distress Syndrome Due to COVID-19, Pregnancy Related
- 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.
Germany1 site, 1 recruiting
- 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.
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 group | Role | What 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.
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)
Catecholamine therapy
Catecholamine therapy during intensive care unit (ICU) treatment is measured in doses and duration.
Measured: 27.03.2020-06.05.2024
Extracorporeal Membrane Oxygenation treatment
Extracorporeal Membrane Oxygenation treatment in the ICU Yes or No
Measured: 27.03.2020-06.05.2024
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
Duration of ventilation during ICU treatment
Duration of ventilation during ICU treatment is measured in hours
Measured: 27.03.2020-06.05.2024
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
Severity of illness
Severity of illness during ICU treatment is assessed with validated intensive care unit scores.
Measured: 27.03.2020-06.05.2024
Incidence of delirium
Incidence of delirium in the ICU is measured with validated delirium scores.
Measured: 27.03.2020-06.05.2024
Duration of delirium
Duration of delirium in the ICU is measured in days
Measured: 27.03.2020-06.05.2024
Sedation Medications
Kind of medications required for sedation.
Measured: 27.03.2020-06.05.2024
Sedation dosage
The amount of drug required for sedation.
Measured: 27.03.2020-06.05.2024
Duration of sedation
Duration of sedation is measured in days.
Measured: 27.03.2020-06.05.2024
Depth of sedation
Depth of sedation during ICU treatment
Measured: 27.03.2020-06.05.2024
Continuous muscle relaxation
Continuous muscle relaxation during ICU treatment
Measured: 27.03.2020-06.05.2024
Vaccination status
Vaccination status at the start of ICU treatment
Measured: 27.03.2020-06.05.2024
COVID-19-specific immunotherapy
COVID-19-specific immunotherapy (e.g., tocilizumab, dexamethasone, baricitinib) during ICU treatment
Measured: 27.03.2020-06.05.2024
Type of Anti-infective therapy
Type of anti-infective therapy during ICU treatment
Measured: 27.03.2020-06.05.2024
Duration of Anti-infective therapy
Duration of anti-infective therapy during ICU treatment is measured in days.
Measured: 27.03.2020-06.05.2024
Week of pregnancy
Week of pregnancy during ICU treatment in the pregnant women group
Measured: 27.03.2020-06.05.2024
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
Organ complications
Organ complications, including bleeding and pregnancy complications during hospital treatment. Data from patient records.
Measured: 27.03.2020-06.05.2024
Nutrition
Nutrition (enteral vs. parenteral) during ICU treatment
Measured: 27.03.2020-06.05.2024
Dialysis 1
Dialysis during ICU treatment (binary)
Measured: 27.03.2020-06.05.2024
Dialysis 2
Dialysis during ICU treatment (duration)
Measured: 27.03.2020-06.05.2024
Intensive care unit mortality
Data from patient records
Measured: 27.03.2020-06.05.2024
Hospital mortality
Data from patient records
Measured: 27.03.2020-06.05.2024
90-day mortality
Data from patient records
Measured: 27.03.2020-06.05.2024
180-day mortality
Data from patient records
Measured: 27.03.2020-06.05.2024
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
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
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
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
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
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
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
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
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
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.
- First posted4 Jul 2025
- Study start22 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-intensive Care Syndromes in Pregnant Patients With Respiratory Failure and COVID-19 Compared to Non-pregnant Patients With Respiratory Failure and COVID-19
- ClinicalTrials.gov ID
- NCT07051967
- Acronym / sponsor ID
- CovPreg
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 Jul 2025 (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 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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Gender: Male
- Diagnosis: Non-COVID or no respiratory 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
Impairment in at least one PICS domain (mobility, cognition, and/or mental health)
Time frame: 27.03.2020-06.05.2024
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.
37 secondary outcomes
Catecholamine therapy
Time frame: 27.03.2020-06.05.2024
Extracorporeal Membrane Oxygenation treatment
Time frame: 27.03.2020-06.05.2024
Need for ventilation during ICU treatment
Time frame: 27.03.2020-06.05.2024
Duration of ventilation during ICU treatment
Time frame: 27.03.2020-06.05.2024
Oxygenation index
Time frame: 27.03.2020-06.05.2024
Severity of illness
Time frame: 27.03.2020-06.05.2024
Incidence of delirium
Time frame: 27.03.2020-06.05.2024
Duration of delirium
Time frame: 27.03.2020-06.05.2024
Sedation Medications
Time frame: 27.03.2020-06.05.2024
Sedation dosage
Time frame: 27.03.2020-06.05.2024
Duration of sedation
Time frame: 27.03.2020-06.05.2024
Depth of sedation
Time frame: 27.03.2020-06.05.2024
Continuous muscle relaxation
Time frame: 27.03.2020-06.05.2024
Vaccination status
Time frame: 27.03.2020-06.05.2024
COVID-19-specific immunotherapy
Time frame: 27.03.2020-06.05.2024
Type of Anti-infective therapy
Time frame: 27.03.2020-06.05.2024
Duration of Anti-infective therapy
Time frame: 27.03.2020-06.05.2024
Week of pregnancy
Time frame: 27.03.2020-06.05.2024
Need for a cesarean section
Time frame: 27.03.2020-06.05.2024
Organ complications
Time frame: 27.03.2020-06.05.2024
Nutrition
Time frame: 27.03.2020-06.05.2024
Dialysis 1
Time frame: 27.03.2020-06.05.2024
Dialysis 2
Time frame: 27.03.2020-06.05.2024
Intensive care unit mortality
Time frame: 27.03.2020-06.05.2024
Hospital mortality
Time frame: 27.03.2020-06.05.2024
90-day mortality
Time frame: 27.03.2020-06.05.2024
180-day mortality
Time frame: 27.03.2020-06.05.2024
Intensive care unit length of stay
Time frame: 27.03.2020-06.05.2024
Duration of Hospital stay
Time frame: 27.03.2020-06.05.2024
Grip strength Test
Time frame: 27.03.2020-06.05.2024
Mobility
Time frame: 27.03.2020-06.05.2024
Cognition 1
Time frame: 27.03.2020-06.05.2024
Cognition 2
Time frame: 27.03.2020-06.05.2024
Mental health
Time frame: 27.03.2020-06.05.2024
PBQ Parent-Child Relationship Questionnaire
Time frame: 27.03.2020-06.05.2024
Edinburgh Postpartum Depression Questionnaire (EPDS)
Time frame: 27.03.2020-06.05.2024
Health-related quality of life
Time frame: 27.03.2020-06.05.2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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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.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
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 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.