NCT04883190

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 353 (actual)
• Sponsor: Hegau-Bodensee-Klinikum Singen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• SARS-CoV2 Infection

Interventions

Type	Name	Description
OTHER	Fulfilling Questionaires	Fulfilling Questionaires PHQ-D (brief) and FSMC

Timeline

• Start date: 2021-05-15
• Primary completion: 2022-06-01
• Completion: 2024-02-01
• First posted: 2021-05-12
• Last updated: 2024-02-28

Locations

1 site across 1 country: Germany