Physical and Mental Fatigue a Long COVID-19 Symptom - Substudy of FSC19-KN Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 353
- Locations
- 1
- Primary Endpoint
- Presence of fatigue
Study Overview
Brief Summary
Prospective, controlled follow-up observation of SARS-CoV-2 positive patients with regard to the aspect of fatigue (cognitive / motor) and psychological disorders in the areas of anxiety, depression and somatization.
Detailed Description
After informed consent is given, questionnaires will be obtained 6 months and 12 months after infection. For analyzing cognitive and motor fatigue, classified in mildly, moderately or severely fatigue the questionnaire will be calculated by The Fatigue Scale for Motor and Cognitive Functions (FSMC).
And the occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome measured by Brief Patient Health Questionnaire.
The FSC19-KN trial already included patients with positive test for SARS-CoV-2 by PCR and volunteers with negative SARS-CoV-2 antibody testing. Verification of exclusion criteria had been completed in the main trial FSC19-KN. After the informed consent to participation in the sub-study is given all inclusion modalities are fulfilled.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient must meet ALL of the following criteria.
- •Participation in the FSC19-KN study
- •Consent to participate in the survey
Exclusion Criteria
- •Failure to give consent to the survey
Outcomes
Primary Outcomes
Presence of fatigue
Time Frame: 12 month after infection
Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue
Secondary Outcomes
- Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.(12 month after infection)