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 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT04729595
Eligibility Criteria:
Inclusion Criteria:
* Subjects 18 years of age and above with at least one risk factor for disease progression (i.e., age≥ 65, hypertension, diabetes, obesity (BMI ≥30 as defined by CDC), cancer, immunodeficiency and in the opinion of the investigator the risk factor is not acutely life-threatening).
* Laboratory confirmed infection of SARS-CoV-2 within 5 days of Baseline/day 1.
* Subjects must meet the severity score of Moderate or greater for two of the first ten symptoms listed in the Patient Reported Outcomes (PRO) at screening.
* Ability to travel to clinic.
* Ability to understand and sign an informed consent form.
* Female subjects of child-bearing potential who are capable of conception must be: post- menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include abstinence, intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject ≥18 years of age and of child bearing potential must agree to practice two acceptable methods of birth control during the study period.
* Ability to swallow a capsule.
* Ability to complete an electronic diary via smartphone or web.
Exclusion Criteria:
* Need for hospitalization based on severe or critical symptoms based on CDC guidance.
* Subject in long-term care facility.
* Known hypersensitivity or contra-indication to Tempol.
* Subjects taking STRONG CYP inhibitors (e.g. fluoxetine, itraconazole, quinidine, clarithromycin).
* In the opinion of the investigator, any reason that would make the follow up of the subject impossible during the study treatment and follow up period. Any reason the subject cannot comply with study and study procedures.
* Subjects receiving any other investigational agent within 4 weeks of Baseline/Day 1.
* Use of non-FDA approved (EUA or full approval)/off label treatments for COVID-19.
* Lactating females.
* History of any known chronic liver or kidney disease.
* Subjects taking drugs with a Narrow Therapeutic Index such as Cyclosporine Digoxin Flecainide Lithium Phenytoin Sirolimus Theophylline, and Warfarin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04729595
Study Brief:
Protocol Section:
NCT04729595