Fatigue a Long COVID-19 Symptom Substudy of FSC19-KN Trial (SubFSC19-KN)

Physical and Mental 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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV2 Infection
• Intervention / Treatment: Other: Fulfilling Questionaires

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.

• Study Type: Observational
• Enrollment (Actual): 353

Contacts and Locations

• Study Contact: Name: Marc Kollum, PD Dr.; Phone Number: 00497731892600; Email: marc.kollum@glkn.de
• Study Contact Backup: Name: Sabrina Geng; Email: sabrina.geng@glkn.de

Study Locations

• Germany
  • BW
    • Singen, BW, Germany, 78224
      • Hegau Bodensee Klinikum Singen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Fulfilling Questionaires PHQ-D (brief) and FSMC
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; Fulfilling Questionaires PHQ-D (brief) and FSMC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.	analyzed by PHQ-D (brief)	6 month after infection
Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.	analyzed by PHQ-D (brief)	12 month after infection

Collaborators and Investigators

• Sponsor: Hegau-Bodensee-Klinikum Singen
• Investigators: Principal Investigator: Marc Kollum, PD Dr., Hegau-Bodensee-Klinikum Singen

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Fatigue; Covid-19 Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Fatigue; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 21-1340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The aim is to publish the results in a peer reviewed medical journal without sharing any participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No