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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04883190
Acronym
SubFSC19-KN
Enrollment
353
Registered
2021-05-12
Start date
2021-05-15
Completion date
2024-02-01
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV2 Infection

Keywords

Fatigue, Covid-19 Disease

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.

Interventions

OTHERFulfilling Questionaires

Fulfilling Questionaires PHQ-D (brief) and FSMC

Sponsors

Hegau-Bodensee-Klinikum Singen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

Patient must meet ALL of the following criteria. 1. Participation in the FSC19-KN study 2. Consent to participate in the survey

Exclusion criteria

1\. Failure to give consent to the survey

Design outcomes

Primary

MeasureTime frameDescription
Presence of fatigue6 month after infectionEvaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue

Secondary

MeasureTime frameDescription
Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.6 month after infectionanalyzed by PHQ-D (brief)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026