COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04467918

Jose ALEXANDRE DE S CRIPPA, MD, PhD

jcrippa@fmrp.usp.br

2020-07-13

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: 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 pneumonia assessed clinically and / or radiologically will not be mandatory for inclusion have a telephone (cellular or landline) that may be available to receive daily calls throughout the study period. willingness to voluntarily participate in the study to accept randomization for either treatment arm. signing of the approved free and informed consent form (icf) by the research ethics committee (cep) and conep

age below 18 years patients who do not want or can fulfill the necessary home isolation for at least 14 days 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 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 inability to use oral medication pregnancy or lactation history of alcohol or drug addiction smoking in the last three years marijuana use in the last three months inability to cooperate with researchers due to cognitive impairment or mental state patients with severe forms of sars-cov-2, (on screening, inclusion or initial visit)

2

University of Sao Paulo

18

100

Brazil

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

100

Prevention of severe/critical stage of Covid19;Time to CoVid19 symptoms relief and number of participants with negative Clinical CoVid19 symptoms as assessed by CTCAE v5.0

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 249, "treatment_name": "Cannabidiol", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]