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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT04987918
Eligibility Criteria:
Symptomatic study:
Inclusion Criteria:
The presence of clinical signs and symptoms consistent with COVID-19. Signs and symptoms include:
* Fever
* Coughing
* Shortness of breath
* Recent loss of sense of smell or taste
* Chills
* Repeated shaking with chills
* Muscle pain
* Headache
* Sore throat
* Vomiting or diarrhea
* Within 1-5 days of symptom onset
* Informed consent for all the samples will be obtained from the subject or obtained from the parent/guardian in case the patient is a minor
* All ages
* All genders
* Pregnant women
Exclusion Criteria:
* Severe disease requiring immediate medical intervention
* Inability to tolerate sampling procedure (nasal swab)
* Failure to provide informed consent
* Nasal deformities preventing sampling by swab
* Ongoing nosebleeds or use of a nasal spray within the last 4 hours.
* Asymptomatic patients
Asymptomatic study:
Inclusion criteria:
* Present to the facility for a COVID-19 test without symptoms
* Informed consent for all specimens will be obtained from the patient or obtained from the parent/guardian in case the patient is a minor
Exclusion Criteria:
Exclusion criteria include one or more of the following:
* Severe disease requiring immediate medical intervention
* Inability to tolerate sampling procedure
* Is below 2 years old
* Failure to provide informed consent
* Nasal deformities preventing sampling by swab
* Ongoing nosebleeds or use of a nasal spray within the last 4 hours.
* Presence of typical symptoms of COVID-19 (fever, sore throat, fatigue, etc.)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04987918
Study Brief:
Protocol Section:
NCT04987918