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Long-term Outcomes in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04508712
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Brief Summary:
Long-term outcomes from coronavirus disease 2019 (COVID-19) are currently unknown. This study will collect daily living status of survivors of COVID-19.

Condition or disease
COVID-19

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Long-term Outcomes in Patients With COVID-19
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Survivors who had been admitted in Leishenshan Hospital for COVID-19 patients in Wuhan, China

Exclusion Criteria:

  • Patients who were < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508712


Contacts
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Contact: Diansan Su, MD,PhD +8618616514088 diansansu@yahoo.com

Locations
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China, Shanghai
Renji Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Pudong, Shanghai, China, 200127
Contact: Diansan Su, MD,PhD    8618616514088    diansansu@yahoo.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Director: Weifeng Yu, MD,PhD Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04508712    
Other Study ID Numbers: COVID-19 Prognosis
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
COVID-19
long-term outcomes