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Long-term Neurocognitive and Psychiatric Consequences in Severe COVID-19 Survivors.

NCT ID: NCT05019300

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-24

Study Completion Date

2021-10-31

Brief Summary

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Long-term neurocognitive and psychiatric consequences of COVID-19 remain mostly unknown to date. It has been reported that coronaviruses cause direct central nervous system infection (Needham et al. 2020). Besides that, new or worsening cognitive impairment commonly occurs and persists in survivors of intensive care unit (ICU) stay (Hosey \& Needham. 2020). The purpose of our study is to search and describe the cognitive and psychiatric long-term consequences of COVID-19 on patients who have been discharged from critical care units. This is an ambidirectional cohort study, that attempts to follow adults discharged from critical Care Units Adults due to COVID-19 up to 12 months after discharge, to evaluate the presence of cognitive impairment, linguistic and phonation function, depression, fatigue, functional gastroenterological symptoms, anxiety, or post traumatic disorder, and performance in activities of daily living and physical response to exercise as well.

Detailed Description

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Conditions

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Covid19 Neurocognitive Dysfunction

Keywords

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COVID-19 Intensive Care Units Functionality Fatigue Anxiety Insomnia Long-term cognitive impairment language disorders Verbal fluency Depression Post traumatic stress exercise endurance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 patients discharged from critical care units

Adults over 18 years of age who have been hospitalized after COVID-19 diagnosis in the critical care units of Red Salud UC Christus who have been cognitively evaluated with Montreal Cognitive Assessment (MoCA) days prior to their discharge. All patients with a previous history of confirmed neurocognitive or psychotic disorders, prior to hospital admission, were excluded.

Exposure: COVID-19 severity

Intervention Type BIOLOGICAL

COVID-19 severity between 4 to 7 points according the seven-category scale of clinical status reported by Huang et al. (2021) and severe to critical symptomatic levels on spectrum of disease reported by Wu and McGoogan (2020).

Interventions

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Exposure: COVID-19 severity

COVID-19 severity between 4 to 7 points according the seven-category scale of clinical status reported by Huang et al. (2021) and severe to critical symptomatic levels on spectrum of disease reported by Wu and McGoogan (2020).

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults over 18 years of age who have been hospitalized at critical care units, who were admitted for a diagnosis of COVID-19 and who present a score on the MOCA® cognitive test of less than 26 points at the time of hospital discharge .

Exclusion Criteria

* History of underlying cognitive disorder. History of underlying primary psychotic disorder. MOCA® cognitive test score greater than or equal to 26 points at the time of hospital discharge.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Constanza Caneo

Clinical Assistant Professor, C-L Psychiatrist, PI NPQCOVID, Advance Interdisciplinary Rehabilitation Register, (AIRR) Covid-19 Working group

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael Medina, PhD

Role: STUDY_DIRECTOR

Pontificia Universidad Catolica de Chile

Arnoldo Riquelme, PhD

Role: STUDY_DIRECTOR

Pontificia Universidad Catolica de Chile

Constanza Caneo, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Carolina Mendez, PhD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

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Centro de Investigaciones Médicas, Centro de Investigación Clínica UC, Hospital Clínico UC, San Carlos de Apoquindo, Departamento de Ciencias de la Salud, Escuela de Medicina, Red UC-Christus, Campus Clínico San JoaPontificia Universidad Catolica de Chile

Santiago, , Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Constanza Caneo, MD

Role: CONTACT

Phone: +56942909250

Email: [email protected]

Carolina Mendez, PhD

Role: CONTACT

Phone: +56 942595693

Email: [email protected]

Facility Contacts

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Constanza Caneo, MD

Role: primary

Carolina Mendez-Orellana, PhD

Role: backup

References

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Hosey MM, Needham DM. Survivorship after COVID-19 ICU stay. Nat Rev Dis Primers. 2020 Jul 15;6(1):60. doi: 10.1038/s41572-020-0201-1.

Reference Type BACKGROUND
PMID: 32669623 (View on PubMed)

Needham 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.

Reference Type BACKGROUND
PMID: 21946660 (View on PubMed)

Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.

Reference Type BACKGROUND
PMID: 32275288 (View on PubMed)

Kotfis K, Williams Roberson S, Wilson JE, Dabrowski W, Pun BT, Ely EW. COVID-19: ICU delirium management during SARS-CoV-2 pandemic. Crit Care. 2020 Apr 28;24(1):176. doi: 10.1186/s13054-020-02882-x.

Reference Type BACKGROUND
PMID: 32345343 (View on PubMed)

Oxley TJ, Mocco J, Majidi S, Kellner CP, Shoirah H, Singh IP, De Leacy RA, Shigematsu T, Ladner TR, Yaeger KA, Skliut M, Weinberger J, Dangayach NS, Bederson JB, Tuhrim S, Fifi JT. Large-Vessel Stroke as a Presenting Feature of Covid-19 in the Young. N Engl J Med. 2020 May 14;382(20):e60. doi: 10.1056/NEJMc2009787. Epub 2020 Apr 28. No abstract available.

Reference Type BACKGROUND
PMID: 32343504 (View on PubMed)

Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

Reference Type BACKGROUND
PMID: 32091533 (View on PubMed)

Huang 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.

Reference Type BACKGROUND
PMID: 33428867 (View on PubMed)

Needham EJ, Chou SH, Coles AJ, Menon DK. Neurological Implications of COVID-19 Infections. Neurocrit Care. 2020 Jun;32(3):667-671. doi: 10.1007/s12028-020-00978-4.

Reference Type BACKGROUND
PMID: 32346843 (View on PubMed)

Alberti P, Beretta S, Piatti M, Karantzoulis A, Piatti ML, Santoro P, Vigano M, Giovannelli G, Pirro F, Montisano DA, Appollonio I, Ferrarese C. Guillain-Barre syndrome related to COVID-19 infection. Neurol Neuroimmunol Neuroinflamm. 2020 Apr 29;7(4):e741. doi: 10.1212/NXI.0000000000000741. Print 2020 Jul. No abstract available.

Reference Type BACKGROUND
PMID: 32350026 (View on PubMed)

Toscano G, Palmerini F, Ravaglia S, Ruiz L, Invernizzi P, Cuzzoni MG, Franciotta D, Baldanti F, Daturi R, Postorino P, Cavallini A, Micieli G. Guillain-Barre Syndrome Associated with SARS-CoV-2. N Engl J Med. 2020 Jun 25;382(26):2574-2576. doi: 10.1056/NEJMc2009191. Epub 2020 Apr 17. No abstract available.

Reference Type BACKGROUND
PMID: 32302082 (View on PubMed)

Solomon T. Neurological infection with SARS-CoV-2 - the story so far. Nat Rev Neurol. 2021 Feb;17(2):65-66. doi: 10.1038/s41582-020-00453-w.

Reference Type BACKGROUND
PMID: 33414554 (View on PubMed)

Valderrama EV, Humbert K, Lord A, Frontera J, Yaghi S. Severe Acute Respiratory Syndrome Coronavirus 2 Infection and Ischemic Stroke. Stroke. 2020 Jul;51(7):e124-e127. doi: 10.1161/STROKEAHA.120.030153. Epub 2020 May 12. No abstract available.

Reference Type BACKGROUND
PMID: 32396456 (View on PubMed)

Beyrouti R, Adams ME, Benjamin L, Cohen H, Farmer SF, Goh YY, Humphries F, Jager HR, Losseff NA, Perry RJ, Shah S, Simister RJ, Turner D, Chandratheva A, Werring DJ. Characteristics of ischaemic stroke associated with COVID-19. J Neurol Neurosurg Psychiatry. 2020 Aug;91(8):889-891. doi: 10.1136/jnnp-2020-323586. Epub 2020 Apr 30. No abstract available.

Reference Type BACKGROUND
PMID: 32354768 (View on PubMed)

Other Identifiers

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1U19AI135972

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0000001

Identifier Type: -

Identifier Source: org_study_id