Status:
UNKNOWN
CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
SARS-CoV2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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-Co...
Detailed Description
The present study will be a single-center, randomized, parallel, double-blind, placebo-controlled clinical trial of CBD in patients with mild to moderate SARS-CoV-2 infection. The investigators will u...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 16 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04467918
Start Date
July 6 2020
End Date
November 16 2021
Last Update
September 28 2021
Active Locations (2)
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1
Serviço de Assistência Médica e Social do Pessoal do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900
2
Unidade de Pronto Atendimento/UPA - 13 de Maio/Dr. Luis Atílio Losi Viana (UPA Covid)
Ribeirão Preto, São Paulo, Brazil, 14090-270