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

SARS-CoV2 Infection Clinical Trial

— SubFSC19-KN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883190
• Other study ID #: 21-1340
• Status: Completed
• Start date: May 15, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Hegau-Bodensee-Klinikum Singen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: February 1, 2024
• Est. primary completion date: June 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Fatigue
• SARS-CoV2 Infection

Intervention

Other:
• Fulfilling Questionaires
Fulfilling Questionaires PHQ-D (brief) and FSMC

Locations

Country	Name	City	State
Germany	Hegau Bodensee Klinikum Singen	Singen	BW

Sponsors (1)

Lead Sponsor	Collaborator
Hegau-Bodensee-Klinikum Singen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Sabrina Geng, Jonas Haberland, Elisabeth Haberland, Julia Hromek, Heidi Zimmermann, et al, (2024), Effects on Fatigue and Depression 11 And 19 Months after a Sars-Cov-2 Infection a Case Control Study, J. Clinical Cardiology and Cardiovascular Intervention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of fatigue	Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue	6 month after infection
Primary	Presence of fatigue	Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue	12 month after infection
Secondary	Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.	analyzed by PHQ-D (brief)	6 month after infection
Secondary	Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.	analyzed by PHQ-D (brief)	12 month after infection