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

NCT04883190 | Completed

• 1 other identifier: 21-1340
• Study Type: observational
• Target: 353
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection

Keywords

Fatigue; Covid-19 Disease

Outcome Measures

Primary Outcomes (2)

• Presence of fatigue

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

  6 month after infection

• Presence of fatigue

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

  12 month after infection

Secondary Outcomes (2)

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

  6 month after infection

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

  12 month after infection

Study Arms (2)

1. after SARS-CoV-2 infection

All participants in the study and control group of the FSC19-KN study will be contacted either by email or by post. We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group.

Other: Fulfilling Questionaires

2. control group with negative antibody test

All participants in the study and control group of the FSC19-KN study will be contacted either by email or by post. We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group.

Other: Fulfilling Questionaires

Interventions

Fulfilling Questionaires OTHER

Fulfilling Questionaires PHQ-D (brief) and FSMC

1. after SARS-CoV-2 infection; 2. control group with negative antibody test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \. Failure to give consent to the survey

Sponsors & Collaborators

• Hegau-Bodensee-Klinikum Singen: lead

Study Sites (1)

Hegau Bodensee Klinikum Singen

Singen, Baden-Wurttemberg, 78224, Germany

Location

Related 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 Interventions, 7(2); DOI:10.31579/2641-0419/348

  RESULT

MeSH Terms

Conditions

COVID-19; Fatigue

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Kollum, PD Dr.

  Hegau-Bodensee-Klinikum Singen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 12, 2021
• Study Start: May 15, 2021
• Primary Completion: June 1, 2022
• Study Completion: February 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)