CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms

• Status: Active, not recruiting
• Trial end date: 2021-11-16
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabidiol (CBD - 300 mg a day) in patients infected with SARS-CoV-2.

The specific objectives are to assess whether, in patients with mild and moderate forms of SARS-CoV-2, daily use of CBD 300 mg for fourteen days is capable of:

i) decrease viral load; ii) modify inflammatory parameters, such as cytokines, measured from serum; iii) reduce clinical and emotional symptoms through daily clinical evaluation; iv) improve sleep; v) reduce hospitalization and worsen the severity of the disease; v) Monitor the possible adverse effects of CBD use in these patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Cannabidiol; Epidiolex

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)