- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04508712
Long-term Outcomes in Patients With COVID-19
October 22, 2020 updated by: RenJi Hospital
Long-term outcomes from coronavirus disease 2019 (COVID-19) are currently unknown.
This study will collect daily living status of survivors of COVID-19.
Study Overview
Status
Unknown
Conditions
Detailed Description
The ongoing pandemic of coronavirus disease 2019 (COVID-19), due to the newly discovered severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2), has caused a worldwide increase in hospitalization for pneumonia with multi- organ disease.
Survival from sepsis is associated with increased risk for mortality for at least 2 years.
Therefore, substantial sequelae including new physical disability, new cognitive impairment and increased vulnerability to further health deterioration are likely to be seen in survivors of COVID-19.
The investigators conduct this study to investigate daily living status of survivors of COVID-19 using telephone interview questionnaire including Activity Daily Living(ADL), modified Medical Research Council(mMRC),modified Telephone Interview for Cognitive Status (TICS-m), Zung Self-rating Depression Scale(SDS), Carcinologic Handicap Index (CHI), and New York Heart Association (NYHA) functional class.
Study Type
Observational
Enrollment (Anticipated)
900
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Diansan Su, MD,PHD
- Phone Number: +8618616514088
- Email: diansansu@yahoo.com
Study Locations
-
-
Shanghai
-
Pudong, Shanghai, China, 200127
- Recruiting
- Renji Hospital, Shanghai Jiaotong University School of Medicine
-
Contact:
- Diansan Su, MD,PhD
- Phone Number: 8618616514088
- Email: diansansu@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study will enroll survivors of COVID-19 aged over 18 years old who had been admitted in Leishenshan Hospital for COVID-19 patients in Wuhan, China.
Description
Inclusion Criteria:
- Survivors who had been admitted in Leishenshan Hospital for COVID-19 patients in Wuhan, China
Exclusion Criteria:
- Patients who were < 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical functions
Time Frame: 4-6 months
|
Physical functions will be assessed using Activities of daily living (ADL) scale.
Minimum value:0, Maximum value: 100.
Higher scores mean a better outcome.
|
4-6 months
|
Respiratory function
Time Frame: 4-6 months
|
Respiratory function will be assessed using modified Medical Research Council(mMRC) scale.
Minimum value:0, Maximum value: 4. Higher scores mean a worse outcome.
|
4-6 months
|
Cognitive function
Time Frame: 4-6 months
|
Cognitive function will be assessed using modified Telephone Interview for Cognitive Status (TICS-m) scale.
Minimum value:0, Maximum value: 50.
Higher scores mean a better outcome.
|
4-6 months
|
Depression status
Time Frame: 4-6 months
|
Depression status will be assessed using Zung Self-rating Depression Scale(SDS).
Minimum value:25, Maximum value: 125.
Higher scores mean a worse outcome.
|
4-6 months
|
Sensory functions
Time Frame: 4-6 months
|
Sensory functions will be assessed using Carcinologic Handicap Index (CHI).
Minimum value:0, Maximum value: 144.
Higher scores mean a worse outcome.
|
4-6 months
|
Heart function
Time Frame: 4-6 months
|
Heart function will be assessed using New York Heart Association (NYHA) functional class.
Minimum value:1, Maximum value: 4. Higher scores mean a worse outcome.
|
4-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Weifeng Yu, MD,PhD, Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2020
Primary Completion (Anticipated)
August 31, 2021
Study Completion (Anticipated)
August 31, 2021
Study Registration Dates
First Submitted
August 8, 2020
First Submitted That Met QC Criteria
August 10, 2020
First Posted (Actual)
August 11, 2020
Study Record Updates
Last Update Posted (Actual)
October 23, 2020
Last Update Submitted That Met QC Criteria
October 22, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID-19 Prognosis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece