Clinical trial NCT04883190: Fatigue a Long COVID-19 Symptom Substudy of FSC19-KN Trial
Official title: Physical and Mental Fatigue a Long COVID-19 Symptom - Substudy of FSC19-KN Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
Keywords: Fatigue
Covid-19 Disease
Lead sponsor: Hegau-Bodensee-Klinikum Singen
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Within the FSC19-KN trial up to 250 SARS-CoV-2 positive patients and 250 volunteers without SARS-CoV-2 infection are included.

We plan to contact all attendees of the FSC19-KN trial which gave permission to contact via e-mail.

They will be asked to contribute the sub-study by declaring their informed consent online. Only if their agreement of participation is given, they can fill in our online questionnaire.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of fatigue
timeFrame: 6 month after infection
measure: Presence of fatigue
timeFrame: 12 month after infection
Secondary outcomes:
measure: Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.
timeFrame: 6 month after infection
measure: Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.
timeFrame: 12 month after infection
Other outcomes:
Locations:
city: Singen
country: Germany
facility: Hegau Bodensee Klinikum Singen
state: BW
Study officials:
affiliation: Hegau-Bodensee-Klinikum Singen
name: Marc Kollum, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Interventions, 7(2); DOI:10.31579/2641-0419/348