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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT04467918
Eligibility Criteria:
Inclusion Criteria:
1. Patients of both sexes, older than 18 years of age, with SARS-CoV-2 infection confirmed in upper or lower respiratory tract secretion, through reverse transcription followed by polymerase chain reaction (RT- PCR), with mild or moderate manifestations of Covid-19, who wish to participate, and consent by signing the informed consent form and not involved in another clinical trial during the study period
2. Pneumonia assessed clinically and / or radiologically will not be mandatory for inclusion
3. Have a telephone (cellular or landline) that may be available to receive daily calls throughout the study period.
4. Willingness to voluntarily participate in the study to accept randomization for either treatment arm.
5. Signing of the approved Free and Informed Consent Form (ICF) by the Research Ethics Committee (CEP) and CONEP
Exclusion Criteria:
1. Age below 18 years
2. Patients who do not want or can fulfill the necessary home isolation for at least 14 days
3. Chronic clinical conditions, severe or not compensated, such as: insulin-dependent diabetes (types 1 or 2); uncontrolled hypertension, lung disease such as asthma or COPD; hematological and liver diseases, chronic kidney disease in advanced stage (grades 3, 4 and 5), metabolic disorders and immunosuppression
4. Use of any medication with potential interaction with CBD (such as chloroquine, clobazan, warfarin, or valproic acid) or history of undesirable reactions prior to the use of this cannabinoid
5. Inability to use oral medication
6. Pregnancy or lactation
7. History of alcohol or drug addiction
8. Smoking in the last three years
9. Marijuana use in the last three months
10. Inability to cooperate with researchers due to cognitive impairment or mental state
11. Patients with severe forms of SARS-CoV-2, (on screening, inclusion or initial visit)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04467918
Study Brief:
Protocol Section:
NCT04467918