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Completed

NCT Number: NCT04883190

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

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.

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Key information

Conditions

SARS-CoV2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Fatigue Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hegau Bodensee Klinikum Singen

Singen, Baden-Wurttemberg, 78224, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient must meet ALL of the following criteria.

  • Participation in the FSC19-KN study
  • Consent to participate in the survey

Exclusion criteria

  • Failure to give consent to the survey

Treatment and study plan

Fulfilling Questionaires

Other

Fulfilling Questionaires PHQ-D (brief) and FSMC

Primary outcomes

  1. Presence of fatigue

    Time frame: 6 month after infection

    Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue

  2. Presence of fatigue

    Time frame: 12 month after infection

    Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue

Secondary outcomes

  1. Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.

    Time frame: 6 month after infection

    analyzed by PHQ-D (brief)

  2. Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.

    Time frame: 12 month after infection

    analyzed by PHQ-D (brief)

Sponsors and collaborators

Lead sponsor

Hegau-Bodensee-Klinikum Singen

Other

Registry information

Official study title

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

Acronym: SubFSC19-KN

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
May 12, 2021
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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