COVID-19 Post-Intensive Care SyndromeNCT05839327
Impact of Mental Health and Cognitive Disorders on Quality of Life in Severe Covid-19 Survivors
An observational study of COVID-19 Post-Intensive Care Syndrome, run by Hospital Sao Domingos.
Trial summary
The objective of this single-center retrospective observational study is to describe cognitive and psychological outcomes and their impact on quality of life after at least 3 months of intensive care unit (ICU) discharge in severe COVID-19 survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Post-Intensive Care Syndrome
- What is being tested?
- Montreal cognitive assessment scale (MOCA)
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 10 Feb 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with coronavirus disease 2019 (COVID-19) admitted to intensive care unit requiring invasive and non-invasive respiratory support evaluated at least 3 months after hospital discharge for cognitive and psycological components of post-intensive care syndrome and the impact on quality of life.
Who may be able to join
- All 18 years and older patients with severe COVID-19, confirmed by real-time reverse transcriptase-polymerase chain reaction., admitted to a 15- bed intensive care unit of a tertiary hospital from April 2020 to October 2021.
Who cannot join
- Still hospitalized or inpatient in rehabilitation facility
- Previous cognitive impairmant
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Mental Health and Cognitive Disorders on Quality of Life in Severe Covid-19
The objective of this single-center retrospective observational study is to describe cognitive and psychological outcomes and their impact on quality of life after at least 3 months of intensive care unit (ICU) discharge in severe COVID-19 survivors.
Read the detailed description
Background: The COVID-19 pandemic has already affected more than 600 million people worldwide and resulted in at least 6 million deaths (https:coronavirus.jhu.edu/map.html). The pandemic has also resulted in a growing population of individuals recovering from acute SARS-CoV-2 infection. Accumulating observational data suggest that these patients often experience a wide range of symptoms after recovery from acute illness. The dysfunctions ranging from motor, cognitive disability, anxiety, depression and post-traumatic stress disorder. However, there is still unknown data about the occurrence of mental health manifestations after a critical illness and their consequences in mid term quality of life.
Purpose: Many patients with coronavirus disease 2019 (COVID-19) required critical care. Mid-term outcomes of the survivors need to be assessed. The objective of this single-center retrospective observational study is to describe their cognitive and psychological outcomes and their impact on quality of life afer at least 3 months following intensive care unit (ICU)-discharge.
Objectives: Our objective will be to evaluate the incidence of non-physical post-intensive care syndrome, such as symptoms of anxiety, depression, cognitive and post-traumatic stress disorder (PTSD) after hospital discharge in our severe COVID-19 population, as well as determining their long-term consequences in quality of life (QoL).
Methods: An observational retrospective study will be conducted, including all patients with severe COVID-19 admitted to the intensive care unit of a private tertiary hospital from April 2020 to October 2021. Patients were routinely assessed after 3 months of ICU discharge in our multidisciplinary follow-up clinic. A trained research team routinely applied the Montreal Cognitive Assessment Scale (MOCA), Hospital Anxiety and Depression Scale (HADS), PCL-C (Post-traumatic Stress Disorder Checklist: Civilian Version) and Short Form Health Survey 36 (SF-36), during the follow-up evaluation.
- Conditions
- COVID-19 Post-Intensive Care Syndrome
- Being tested
- Montreal cognitive assessment scale (MOCA)
- Keywords
- COVID-19, Critically ill patients, Cognitive disorders, Post-traumatic stress disorder, Anxiety, Depression, Post-intensive care syndrome
- Medical subject headings
- COVID-19 post-intensive care syndrome, COVID-19, Cognitive Dysfunction, Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montreal cognitive assessment scale (MOCA)Diagnostic test
Also called Hospital anxiety and depression scale ( HADS), Post-traumatic stress disorder checklist civilian version (PCL-C), Short form health survey 36 (SF-36)
Tests to evaluate cognitive disorders (MOCA), anxiety and depression (HADS) Pos-traumatic stress disorder (PCL-C) and quality of life (SF-36)
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment Scale (MOCA)
The MoCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorders (≥ 26) and proven cognitive impairments (< 26)
The MoCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorders (≥ 26) and proven cognitive impairments (< 26)
The MoCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorders (≥ 26) and proven cognitive impairments (< 26)
The MOCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorder (> 26) and
Measured: 6 months after hospital discharge
Hospital Anxiety and depression scale (HADS)
The HADS consists of two 7-item subscales evaluating symptoms of depression (seven items-HADS-D subscale) and symptoms of anxiety (seven items-HADS-A subscale). The standard cutoff threshold value of > 7 out of 21 on either subscale was used to define a borderline status (score 8 to 10) or clinically significant status (score 11 to 21) of depression or anxiety, respectively.
Measured: 6 months after hospital discharge
Post-traumatic Stress Disorder Checklist: Civilian Version (PCL-C)
PCL-C is an instrument designed to assess the consequences of a number of different types of traumatic experience. To complete the questionnaire, the subject should gauge to what extent they have been disturbed by the symptoms described during the previous month, using a scale of severity from 1 to 5 (not at all to very much). It defines a score greater than or equal to 3 (average) for any of the 17 items as clinically significant.
PCL-C is an instrument designed to assess the consequences of a number of different types of traumatic experience. To complete the questionnaire, the subject should gauge to what extent they have been disturbed by the symptoms described during the previous month, using a scale of severity from 1 to 5 (not at all to very much). It defines a score greater than or equal to 3 (average) for any of the 17 items as clinically significant.
Measured: 6 months after hospital discharge
Secondary outcomes (1)
Mental Component Summary (MCS) of Short Form- 36 (SF-36) Instrument
MCS is composed of scales assessing mental function, role limitations caused by mental problems, bodily pain and general health. The result scale ranges from 0 to 100, with 0 being the worst result and 100 the best.
Measured: 6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion10 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Post-Intensive Care SyndromeStudies 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
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Domingos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
- Investigators
- JOAQUIM C LOBATO FILHO, MD, Principal investigator, Hospital Sao DomingosJOSE R AZEVEDO, MD, PhD, Study chair, Hospital Sao Domingos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839327
- Sponsor's protocol ID
- 15/2023
- Status last verified
- Apr 2023
- First submitted
- 30 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lambermont B, Rousseau AF, Seidel L, Thys M, Cavalleri J, Delanaye P, Chase JG, Gillet P, Misset B. Outcome Improvement Between the First Two Waves of the Coronavirus Disease 2019 Pandemic in a Single Tertiary-Care Hospital in Belgium. Crit Care Explor. 2021 May 19;3(5):e0438. doi: 10.1097/CCE.0000000000000438. eCollection 2021 May.
PubMed 34079951Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
PubMed 21946660Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome. Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22.
PubMed 33753937Martillo MA, Dangayach NS, Tabacof L, Spielman LA, Dams-O'Connor K, Chan CC, Kohli-Seth R, Cortes M, Escalon MX. Postintensive Care Syndrome in Survivors of Critical Illness Related to Coronavirus Disease 2019: Cohort Study From a New York City Critical Care Recovery Clinic. Crit Care Med. 2021 Sep 1;49(9):1427-1438. doi: 10.1097/CCM.0000000000005014.
PubMed 33769771Mongodi S, Salve G, Tavazzi G, Politi P, Mojoli F; COVID-19 Post-ICU team; COVID-19 Pavia Crisis Unit. High prevalence of acute stress disorder and persisting symptoms in ICU survivors after COVID-19. Intensive Care Med. 2021 May;47(5):616-618. doi: 10.1007/s00134-021-06349-7. Epub 2021 Mar 17. No abstract available.
PubMed 33730197Ramani C, Davis EM, Kim JS, Provencio JJ, Enfield KB, Kadl A. Post-ICU COVID-19 Outcomes: A Case Series. Chest. 2021 Jan;159(1):215-218. doi: 10.1016/j.chest.2020.08.2056. Epub 2020 Aug 21. No abstract available.
PubMed 32835708Valent A, Dudoignon E, Ressaire Q, Depret F, Plaud B. Three-month quality of life in survivors of ARDS due to COVID-19: A preliminary report from a French academic centre. Anaesth Crit Care Pain Med. 2020 Dec;39(6):740-741. doi: 10.1016/j.accpm.2020.10.001. Epub 2020 Oct 10. No abstract available.
PubMed 33049394Writing Committee for the COMEBAC Study Group; Morin L, Savale L, Pham T, Colle R, Figueiredo S, Harrois A, Gasnier M, Lecoq AL, Meyrignac O, Noel N, Baudry E, Bellin MF, Beurnier A, Choucha W, Corruble E, Dortet L, Hardy-Leger I, Radiguer F, Sportouch S, Verny C, Wyplosz B, Zaidan M, Becquemont L, Montani D, Monnet X. Four-Month Clinical Status of a Cohort of Patients After Hospitalization for COVID-19. JAMA. 2021 Apr 20;325(15):1525-1534. doi: 10.1001/jama.2021.3331.
PubMed 33729425McCue C, Cowan R, Quasim T, Puxty K, McPeake J. Long term outcomes of critically ill COVID-19 pneumonia patients: early learning. Intensive Care Med. 2021 Feb;47(2):240-241. doi: 10.1007/s00134-020-06313-x. Epub 2020 Nov 9. No abstract available.
PubMed 33169214Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
PubMed 33428867Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Jenkinson C, Layte R, Jenkinson D, Lawrence K, Petersen S, Paice C, Stradling J. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies? J Public Health Med. 1997 Jun;19(2):179-86. doi: 10.1093/oxfordjournals.pubmed.a024606.
PubMed 9243433
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mental Health and Cognitive Disorders on Quality of Life in Severe Covid-19
- ClinicalTrials.gov ID
- NCT05839327
- Acronym / sponsor ID
- 15/2023
- Conditions
- COVID-19 Post-Intensive Care Syndrome
- Keywords
- COVID-19, Critically ill patients, Cognitive disorders, Post-traumatic stress disorder, Anxiety, Depression, Post-intensive care syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Hospital Sao DomingosUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 10 Feb 2024 (estimated)
- First posted
- 3 May 2023 (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 objective of this single-center retrospective observational study is to describe cognitive and psychological outcomes and their impact on quality of life after at least 3 months of intensive care unit (ICU) discharge in severe COVID-19 survivors.
Detailed description
Background: The COVID-19 pandemic has already affected more than 600 million people worldwide and resulted in at least 6 million deaths (https:coronavirus.jhu.edu/map.html). The pandemic has also resulted in a growing population of individuals recovering from acute SARS-CoV-2 infection. Accumulating observational data suggest that these patients often experience a wide range of symptoms after recovery from acute illness. The dysfunctions ranging from motor, cognitive disability, anxiety, depression and post-traumatic stress disorder. However, there is still unknown data about the occurrence of mental health manifestations after a critical illness and their consequences in mid term quality of life.
Purpose: Many patients with coronavirus disease 2019 (COVID-19) required critical care. Mid-term outcomes of the survivors need to be assessed. The objective of this single-center retrospective observational study is to describe their cognitive and psychological outcomes and their impact on quality of life afer at least 3 months following intensive care unit (ICU)-discharge.
Objectives: Our objective will be to evaluate the incidence of non-physical post-intensive care syndrome, such as symptoms of anxiety, depression, cognitive and post-traumatic stress disorder (PTSD) after hospital discharge in our severe COVID-19 population, as well as determining their long-term consequences in quality of life (QoL).
Methods: An observational retrospective study will be conducted, including all patients with severe COVID-19 admitted to the intensive care unit of a private tertiary hospital from April 2020 to October 2021. Patients were routinely assessed after 3 months of ICU discharge in our multidisciplinary follow-up clinic. A trained research team routinely applied the Montreal Cognitive Assessment Scale (MOCA), Hospital Anxiety and Depression Scale (HADS), PCL-C (Post-traumatic Stress Disorder Checklist: Civilian Version) and Short Form Health Survey 36 (SF-36), during the follow-up evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with coronavirus disease 2019 (COVID-19) admitted to intensive care unit requiring invasive and non-invasive respiratory support evaluated at least 3 months after hospital discharge for cognitive and psycological components of post-intensive care syndrome and the impact on quality of life.
Key inclusion criteria (1 listed)
- All 18 years and older patients with severe COVID-19, confirmed by real-time reverse transcriptase-polymerase chain reaction., admitted to a 15- bed intensive care unit of a tertiary hospital from April 2020 to October 2021.
Key exclusion criteria (2 listed)
- Still hospitalized or inpatient in rehabilitation facility
- Previous cognitive impairmant
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 |
|---|---|---|
| Montreal cognitive assessment scale (MOCA)Also: Hospital anxiety and depression scale ( HADS), Post-traumatic stress disorder checklist civilian version (PCL-C), Short form health survey 36 (SF-36)Tests to evaluate cognitive disorders (MOCA), anxiety and depression (HADS) Pos-traumatic stress disorder (PCL-C) and quality of life (SF-36) | Diagnostic test | – |
Primary outcome
Montreal Cognitive Assessment Scale (MOCA)
Time frame: 6 months after hospital discharge
The MoCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorders (≥ 26) and proven cognitive impairments (< 26) The MoCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorders (≥ 26) and proven cognitive impairments (< 26) The MoCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorders (≥ 26) and proven cognitive impairments (< 26) The MOCA total score was used for analysis: it ranges from 0 to 30, the lower scores indicating worse cognitive performances. The validated cut-off of 26 was used to distinguish light cognitive disorder (> 26) and
Hospital Anxiety and depression scale (HADS)
Time frame: 6 months after hospital discharge
The HADS consists of two 7-item subscales evaluating symptoms of depression (seven items-HADS-D subscale) and symptoms of anxiety (seven items-HADS-A subscale). The standard cutoff threshold value of > 7 out of 21 on either subscale was used to define a borderline status (score 8 to 10) or clinically significant status (score 11 to 21) of depression or anxiety, respectively.
Post-traumatic Stress Disorder Checklist: Civilian Version (PCL-C)
Time frame: 6 months after hospital discharge
PCL-C is an instrument designed to assess the consequences of a number of different types of traumatic experience. To complete the questionnaire, the subject should gauge to what extent they have been disturbed by the symptoms described during the previous month, using a scale of severity from 1 to 5 (not at all to very much). It defines a score greater than or equal to 3 (average) for any of the 17 items as clinically significant. PCL-C is an instrument designed to assess the consequences of a number of different types of traumatic experience. To complete the questionnaire, the subject should gauge to what extent they have been disturbed by the symptoms described during the previous month, using a scale of severity from 1 to 5 (not at all to very much). It defines a score greater than or equal to 3 (average) for any of the 17 items as clinically significant.
1 secondary outcome
Mental Component Summary (MCS) of Short Form- 36 (SF-36) Instrument
Time frame: 6 months after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 34079951Lambermont B, Rousseau AF, Seidel L, Thys M, Cavalleri J, Delanaye P, Chase JG, Gillet P, Misset B. Outcome Improvement Between the First Two Waves of the Coronavirus Disease 2019 Pandemic in a Single Tertiary-Care Hospital in Belgium. Crit Care Explor. 2021 May 19;3(5):e0438. doi: 10.1097/CCE.0000000000000438. eCollection 2021 May.
- Results publication: PubMed 21946660Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
- Results publication: PubMed 33753937Nalbandian A, Sehgal K, Gupta A, Madhavan MV, McGroder C, Stevens JS, Cook JR, Nordvig AS, Shalev D, Sehrawat TS, Ahluwalia N, Bikdeli B, Dietz D, Der-Nigoghossian C, Liyanage-Don N, Rosner GF, Bernstein EJ, Mohan S, Beckley AA, Seres DS, Choueiri TK, Uriel N, Ausiello JC, Accili D, Freedberg DE, Baldwin M, Schwartz A, Brodie D, Garcia CK, Elkind MSV, Connors JM, Bilezikian JP, Landry DW, Wan EY. Post-acute COVID-19 syndrome. Nat Med. 2021 Apr;27(4):601-615. doi: 10.1038/s41591-021-01283-z. Epub 2021 Mar 22.
- Results publication: PubMed 33769771Martillo MA, Dangayach NS, Tabacof L, Spielman LA, Dams-O'Connor K, Chan CC, Kohli-Seth R, Cortes M, Escalon MX. Postintensive Care Syndrome in Survivors of Critical Illness Related to Coronavirus Disease 2019: Cohort Study From a New York City Critical Care Recovery Clinic. Crit Care Med. 2021 Sep 1;49(9):1427-1438. doi: 10.1097/CCM.0000000000005014.
- Results publication: PubMed 33730197Mongodi S, Salve G, Tavazzi G, Politi P, Mojoli F; COVID-19 Post-ICU team; COVID-19 Pavia Crisis Unit. High prevalence of acute stress disorder and persisting symptoms in ICU survivors after COVID-19. Intensive Care Med. 2021 May;47(5):616-618. doi: 10.1007/s00134-021-06349-7. Epub 2021 Mar 17. No abstract available.
- Results publication: PubMed 32835708Ramani C, Davis EM, Kim JS, Provencio JJ, Enfield KB, Kadl A. Post-ICU COVID-19 Outcomes: A Case Series. Chest. 2021 Jan;159(1):215-218. doi: 10.1016/j.chest.2020.08.2056. Epub 2020 Aug 21. No abstract available.
- Results publication: PubMed 33049394Valent A, Dudoignon E, Ressaire Q, Depret F, Plaud B. Three-month quality of life in survivors of ARDS due to COVID-19: A preliminary report from a French academic centre. Anaesth Crit Care Pain Med. 2020 Dec;39(6):740-741. doi: 10.1016/j.accpm.2020.10.001. Epub 2020 Oct 10. No abstract available.
- Results publication: PubMed 33729425Writing Committee for the COMEBAC Study Group; Morin L, Savale L, Pham T, Colle R, Figueiredo S, Harrois A, Gasnier M, Lecoq AL, Meyrignac O, Noel N, Baudry E, Bellin MF, Beurnier A, Choucha W, Corruble E, Dortet L, Hardy-Leger I, Radiguer F, Sportouch S, Verny C, Wyplosz B, Zaidan M, Becquemont L, Montani D, Monnet X. Four-Month Clinical Status of a Cohort of Patients After Hospitalization for COVID-19. JAMA. 2021 Apr 20;325(15):1525-1534. doi: 10.1001/jama.2021.3331.
- Results publication: PubMed 33169214McCue C, Cowan R, Quasim T, Puxty K, McPeake J. Long term outcomes of critically ill COVID-19 pneumonia patients: early learning. Intensive Care Med. 2021 Feb;47(2):240-241. doi: 10.1007/s00134-020-06313-x. Epub 2020 Nov 9. No abstract available.
- Results publication: PubMed 33428867Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
- Results publication: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Results publication: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Individual participant dataSharing planned: No
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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.
JOAQUIM C LOBATO FILHO, MD principal investigator
Hospital Sao Domingos
JOSE R AZEVEDO, MD, PhD study chair
Hospital Sao Domingos
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Post-Intensive Care Syndrome, run by Hospital Sao Domingos.
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 1 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: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JOSE R AZEVEDO, MD, PhD (+559832168110, jrazevedo47@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment Scale (MOCA) (time frame: 6 months after hospital discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05839327, which also lists 13 linked publications.
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 3 May 2023.