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

NCT ID: NCT04883190

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-15

Study Completion Date

2024-02-01

Brief Summary

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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

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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.

Conditions

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SARS-CoV2 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Fulfilling Questionaires

Intervention Type OTHER

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.

Fulfilling Questionaires

Intervention Type OTHER

Fulfilling Questionaires PHQ-D (brief) and FSMC

Interventions

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Fulfilling Questionaires

Fulfilling Questionaires PHQ-D (brief) and FSMC

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hegau-Bodensee-Klinikum Singen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Kollum, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Hegau-Bodensee-Klinikum Singen

Locations

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Hegau Bodensee Klinikum Singen

Singen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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

Reference Type RESULT

Other Identifiers

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21-1340

Identifier Type: -

Identifier Source: org_study_id

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