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

Hegau-Bodensee-Klinikum Singen

Status: Completed

Conditions: SARS-CoV2 Infection

Treatments: Other: Fulfilling Questionaires

Study type: Observational

Funder types: Other

Identifiers

NCT04883190

21-1340

Details and patient eligibility

About

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.

Full 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.

Enrollment: 353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

353 participants in 2 patient groups

1. after SARS-CoV-2 infection

Description:

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.

Treatment:

Other: Fulfilling Questionaires

2. control group with negative antibody test

Description:

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.

Treatment:

Other: Fulfilling Questionaires