Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT05650905
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for healthy subjects
* Men and women aged over 18 years
* Non-smokers
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* No previous history of COVID-19 infection
* Negative testing for SARS-CoV-2 seroprevalence using nucleocapsid antibody tests
* Negative PCR test for SARS-CoV-2
* Normal ophthalmic findings, ametropy \< 6 Dpt.
Inclusion criteria for subjects with history of COVID-19 infection
* Men and women aged over 18 years
* Non-smokers
* History of COVID-19 infection (confirmed by a positive PCR test for SARS-CoV2 in the medical history) within the last 6 months
* Positive testing for SARS-CoV-2 seroprevalence using spike protein IgG antibody tests
* Negative PCR test for SARS-CoV-2
Inclusion criteria for subjects with long COVID-19
* Men and women aged over 18 years
* Non-smokers
* History of COVID-19 infection (confirmed by a positive PCR test for SARS-CoV2 in the medical history)
* Positive testing for SARS-CoV-2 seroprevalence
* Negative PCR test for SARS-CoV-2
* Long Covid according to the latest WHO-Guidelines
Exclusion Criteria:
Any of the following will exclude a healthy control subject from the study:
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition as judged by the clinical investigator
* Participation in a clinical trial in the 3 weeks preceding the study
* Blood donation during the previous three weeks
* History or family history of epilepsy
* Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
* Best corrected visual acuity \< 0.8 Snellen
* Pregnancy, planned pregnancy or lactatin
* History of epilepsia
Any of the following will exclude a subject with history of COVID-19 infection from the study:
* Blood donation during the previous three weeks
* History or family history of epilepsy
* Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
* Best corrected visual acuity \< 0.8 Snellen
* Ametropy \>6 Dpt
* Pregnancy, planned pregnancy or lactating
* History of epilepsia
Any of the following will exclude a subject with long COVID-19 from the study:
* Blood donation during the previous three weeks
* History or family history of epilepsy
* Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
* Best corrected visual acuity \< 0.8 Snellen
* Ametropy \>6 Dpt
* Pregnancy, planned pregnancy or lactating
* History of epilepsia
* Diabetes mellitus
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05650905
Study Brief:
Protocol Section:
NCT05650905