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:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT05605769
Eligibility Criteria:
Phase 1 Inclusion Criteria:
* 18 years of age
* Able to speak and read local language depending on site of recruitment
* Provided voluntary written consent to participate in this stud
Phase 11 inclusion Criteria:
* 18 years of age
* Able to speak and read local language depending on site of recruitment
* Suspected to have COVID-19 (as per WHO or national guidelines).
* SYMPTOMATIC group)
* Contacts of confirmed cases of COVID-19
* Individuals residing or working in an area with high risk of transmission of virus
* Individuals residing or travelling to an area with community transmission
* Individuals working in any health care setting, including within health facilities or within the community
* Written consent
* Provided the required number of specimens suitable for testing. Exclusion criteria
* Participated in Phase I or Phase II of the study
* Prior medical or clinical laboratory training
* Prior experience with self-testing for SARS-CoV-2
* Hemodynamic instability as determined by the treating physician
* unable to cooperate with respiratory sample collection or on oxygen therapy
* Recent history of excessive nose bleeds
* Any condition which, in the opinion of the investigator feels unable to participate in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05605769
Study Brief:
Protocol Section:
NCT05605769