Fatigue a Long COVID-19 Symptom Substudy of FSC19-KN Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physical and Mental Fatigue a Long COVID-19 Symptom - Substudy of FSC19-KN Trial

Conditions
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SARS-CoV2 Infection

Intervention / Treatment
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* Other: Fulfilling Questionaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must meet ALL of the following criteria. Participation in the FSC19-KN study Consent to participate in the survey Exclusion Criteria: 1. Failure to give consent to the survey

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1. after SARS-CoV-2 infection<br>All participants in the study and control group of the FSC19-KN study will be contacted either by email or by post. We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group. | Other: Fulfilling Questionaires<br>* Fulfilling Questionaires PHQ-D (brief) and FSMC<br>|
| 2. control group with negative antibody test<br>All participants in the study and control group of the FSC19-KN study will be contacted either by email or by post. We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group. | Other: Fulfilling Questionaires<br>* Fulfilling Questionaires PHQ-D (brief) and FSMC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of fatigue | Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue | 6 month after infection | 
| Presence of fatigue | Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue | 12 month after infection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome. | analyzed by PHQ-D (brief) | 6 month after infection | 
| Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome. | analyzed by PHQ-D (brief) | 12 month after infection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Covid-19 Disease