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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT04443868
Eligibility Criteria:
Inclusion Criteria:
* Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;
* Men and Women ≥ 18years of age;
* Internet access and capability and willingness to use to participate in audio or audio/video engagements with medical professionals, receive texts, emails, and phone calls from study staff and have a device and reasonable cellular data or other internet access to submit daily study required information using a smart phone, tablet, laptop, or desktop computer during the study period;
* COVID-19 infection confirmed with a laboratory antigen or SARS-CoV-2 RT-PCR nasal swab;
* Specimen collected within the past 48 hours;
* Mild COVID /FLU symptoms which may include no symptoms, fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath or dyspnea;
* Must be willing to use one highly effective birth control method which include: abstinence, hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation or to use two forms of effective birth control methods which include: barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge);
* Hormonal methods and the IUD must be in use at least 30 days prior to first Study drug administration
* Abstinence and barrier methods must be in use at least 14 days prior to Study drug administration
* Vasectomy must be completed 3 months prior to first Study drug administration; or in the alternative that a 0 sperm count will suffice.
Exclusion Criteria:
* Current tracheostomy or laryngectomy;
* Concomitant respiratory therapy such as oxygen or ventilatory support. Positive airway pressure for obstructive sleep apnea is permitted if treatment was established with good compliance at least 3 months before enrolment;
* Need for hospitalization for any reason;
* Inability to safely self-administer nasal irrigation
* Any clinical contraindications, as judged by the Qualified Medical Practitioner;
* Clinical signs indicative of moderate, severe or critical COVID severity symptoms (as defined by FDA COVID-19 Guidance Document)
* Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;
* Lactating, pregnant or planning to become pregnant during the study period;
* Diagnosed with prior COVID-19 infection (\>48 hours from the time the test is reported prior to the time of screening).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04443868
Study Brief:
Protocol Section:
NCT04443868