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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041276
Receipt No. R000047140
Scientific Title Post-Intensive Care outcomeS of patients with COronaVIrus Disease 2019; PICS-COVID study
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/01

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Basic information
Public title Post-Intensive Care outcomeS of patients with COronaVIrus Disease 2019; PICS-COVID study
Acronym Post-Intensive Care outcomeS of patients with COronaVIrus Disease 2019; PICS-COVID study
Scientific Title Post-Intensive Care outcomeS of patients with COronaVIrus Disease 2019; PICS-COVID study
Scientific Title:Acronym Post-Intensive Care outcomeS of patients with COronaVIrus Disease 2019; PICS-COVID study
Region
Japan

Condition
Condition Adult coronavIrus disease 2019 patients discharged from the intensive care unit who were able to walk on their own without assistance prior to infection.
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the incidence of post-intensive care syndrome in patients with severe COVID-19.
Basic objectives2 Others
Basic objectives -Others To investigate the incidence of post-intensive care syndrome in patients with severe COVID-19.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Short-Memory Questionnaire (SMQ), Barthel Index, Hospital Anxiety and Depression Scale (HADS), and visual analogue scale such as EuroQol 5 Dimension (EQ-5D)-5L and EQ-5D-VAS by questionnaire at 6, 12, and 24 months after ICU discharge
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adult COVID19 patients leaving the intensive care unit between March 2020 and June 2020
Key exclusion criteria Patients unable to walk on their own before SARS-CoV-2 infection
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Junji
Middle name
Last name Hatakeyama
Organization National Hospital Organization Tokyo Medical Center
Division name Department of Emergency and Critical Care Medicine
Zip code 152-8902
Address 2-5-1, Higashigaoka Meguro-ku, Tokyo
TEL 03-3411-0111
Email hatakeyama-jik@umin.ac.jp

Public contact
Name of contact person
1st name Junji
Middle name
Last name Hatakeyama
Organization National Hospital Organization Tokyo Medical Center
Division name Department of Emergency and Critical Care Medicine
Zip code 152-8902
Address 2-5-1, Higashigaoka Meguro-ku, Tokyo
TEL 03-3411-0111
Homepage URL
Email hatakeyama-jik@umin.ac.jp

Sponsor
Institute National Hospital Organization Tokyo Medical Center
Institute
Department

Funding Source
Organization Nestle Health Science
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Tokyo Medical Center
Address 2-5-1, Higashigaoka Meguro-ku, Tokyo
Tel 03-3411-0111
Email hatakeyama-jik@umin.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 08 Month 01 Day
Last modified on
2020 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047140

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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