Exploration of the lung microbiome of post-covid syndrome patients, using ,,next-generation sequencing (nanopore sequencing)

Conditions: U09.9
Post COVID-19 condition, unspecified

Registration Number: DRKS00027809

Lead Sponsor: MVZ Laborärzte Singen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 202

Inclusion Criteria

Inclusion Criteria Post-Covid Syndrome Patients:

- Age of majority
- Diagnosed Post-Covid Syndrome (Which includes a previously contracted Covid-19 infection confirmed by PCR test).
- a confirmed previously acquired Covid-19 infection (PCR test).
- Furthermore, vaccinated and non-vaccinated patients will be included.

Inclusion Criteria control group:
- Age of majority
- Vaccinated and non-vaccinated patients will be included.

Exclusion Criteria

Exclusion Criterion Post-Covid Syndrome Patients:
- Positive PCR test at specimen collection (A PCR test will be performed from sputum at specimen collection to ensure that there is no active undetected infection. This is regulated by the informed consent).

Exclusion Criteria Control Group:
- Positive PCR test at specimen collection (A PCR test will be performed from the sputum at specimen collection to ensure that there is no active undetected infection. This is regulated by the consent form).
- Previous knowingly confirmed passed Covid-19 infection (PCR test).

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary goal<br>The lung microbiome of participants will be investigated using sputum samples. Accordingly, NO experiments will be performed on participants/patients (post-covid syndrome). Of interest is the change in the lung microbiome associated with post-covid syndrome compared to healthy participants (cohort analysis/prospective study). These changes will be shown by NGS.<br><br>Primary outcome measure<br>Difference of the microbiome of healthy subjects to the microbiome of patients suffering from post-covid syndrome, measured by alpha diversity.

Secondary Outcome Measures

Name	Time	Method
Secondary goal<br>Furthermore, samples will be taken from post-covid syndrome patients multiple times (e.g. at the beginning of rehabilitation and at the end of rehabilitation) to show the recovery of the lung microbiome (longitudinal analysis/ prospective study).<br><br>Secondary outcome measure<br>To show is the normalization of the lung microbiome of post-covid syndrome patients over the period of rehabilitation in the direction of the control group, measured by alpha diversity.