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National library of Medicine
National Center for Biotechnology Information
National Library of Medicine
National Center for Biotechnological Information
Published on: October 7, 2021
It applies to studies registered on the 13th line of 2020
Cannabidiol for patients with mild to moderate symptoms of COVID-19 disease
(CANDIDATE study): Randomized, double-blind, placebo-controlled clinical trial
José Alexandre S Crippa 1 2, Julia Cozar Pacheco 1, Antonio W Zuardi 1 2, Francisco S Guimarães 2 3, Alline Cristina Campos 3, Flávia de Lima Osório 1 2, Sonia Regina Loureiro 1, Rafael G Dos Santos 1 2, José Diogo S Souza 1, Juliana Mayumi Ushirohira 1, Rafael Rinaldi Ferreira 3, Karla Cristinne Mancini Costa 3, Davi Silveira Scomparin 3, Franciele Franco Scarante 3, Isabela Pires-Dos-Santos 3, Raphael Mechoulam 4, Flávio Kapczinski 2 5 6, Benedito A L Fonseca 7, Danillo L A Esposito 7, Afonso Dinis Costa Passos 8, Amaury Lelis Dal Fabbro 8, Fernando Bellissimo-Rodrigues 8, Eurico Arruda 9, Sandro Scarpelini 10, Maristela Haddad Andraus 11, Julio Cesar Nather Junior 12, Danilo Tadao Wada 12, Marcel Koenigkam-Santos 12, Antonio Carlos Santos 12, Geraldo Busatto Filho 13, Jaime E C Hallak 1 2
Affiliations expand
PMID: 34619044 DOI: 10.1089 / can.2021.0093
Summary:
Meaning (Study importance): Due to its anti-inflammatory properties and “in vitro” antiviral activity against Coronavirus 2 Severe Acute Respiratory Syndrome (SARS-CoV-2), cannabidiol (CBD) has been proposed as a potential treatment for coronavirus disease 2019 (COVID-19) .
Aim: To test the safety and efficacy of CBD in treating patients with mild to moderate COVID-19.
Design: Randomized, parallel group, double-blind, placebo-controlled clinical trial conducted between July 7 and October 16, 2020, at two sites in Brazil.
Project strategy: Patients were recruited in the emergency room.
Participants: Patients with block randomization (allocation ratio 1: 1 – by an investigator not directly involved in data collection) with mild to moderate COVID-19
living in Ribeirão Preto, Brazil, seeking a medical consultation, and those who have voluntarily agreed to participate in the study.
Interventions: Patients received either 300 mg of CBD or a placebo in addition to standard symptomatic care for 14 days.
Main Outcome and Measure: The primary outcome was the reduction or prevention of mild / moderate to severe / critical clinical deterioration as measured by the COVID-19 scale or the natural course of recovery from typical clinical symptoms. The primary study outcome was assessed on days 14, 21, and 28 post-study entry.
Results: 321 patients were enrolled in the study, 105 of whom were randomized to receive either CBD (n = 49) or placebo (n = 42). Ninety-one participants were included in the efficacy analysis. There were no baseline differences between the groups in terms of disease severity (χ2 = 0.025, p = 0.988) and median time to symptom relief (12 days [95% confidence interval, CI, 6.5-17.5] in the CBD group, 9 days [95% CI, 4.8-13.2] in the placebo group [χ2 = 1.6, p = 0.205 by log-rank test]). By day 28, 83.3% of patients in the CBD group and 90.2% in the placebo group had symptom relief. There were no differences between groups in secondary measures. CBD was well tolerated, causing mainly mild and transient side effects (e.g., somnolence, fatigue, changes in appetite, somnolence, nausea, diarrhea, and fever), with no significant differences between the CBD and placebo treatment groups.
Conclusions and Meaning: Daily administration of 300 mg of CBD for 14 days did not change the clinical evolution of COVID-19. Further research should investigate the therapeutic effect of CBD in severe COVID-19 patients, possibly trying higher doses than those used in our study. Study registration: ClinicalTrials.gov ID NCT04467918 (registration date: July 13, 2020).
Keywords: COVID-19; SARS-CoV-2; cannabidiol; clinical trial; infectious diseases; internal diseases.
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National Library of Medicine
National Center for Biotechnological Information
Published on: October 7, 2021
It applies to studies registered on the 13th line of 2020
Cannabidiol for patients with mild to moderate symptoms of COVID-19 disease
(CANDIDATE study): Randomized, double-blind, placebo-controlled clinical trial
Summary:
Meaning (Study importance): Due to its anti-inflammatory properties and “in vitro” antiviral activity against Coronavirus 2 Severe Acute Respiratory Syndrome (SARS-CoV-2), cannabidiol (CBD) has been proposed as a potential treatment for coronavirus disease 2019 (COVID-19) .
Aim: To test the safety and efficacy of CBD in treating patients with mild to moderate COVID-19.
Design: Randomized, parallel group, double-blind, placebo-controlled clinical trial conducted between July 7 and October 16, 2020, at two sites in Brazil.
Project strategy: Patients were recruited in the emergency room.
Participants: Patients with block randomization (allocation ratio 1: 1 – by an investigator not directly involved in data collection) with mild to moderate COVID-19 living in Ribeirão Preto, Brazil seeking medical consultation, and those who voluntarily agreed to participate in the study .
Interventions: Patients received either 300 mg of CBD or a placebo in addition to standard symptomatic care for 14 days.
Main Outcome and Measure: The primary outcome was the reduction or prevention of mild / moderate to severe / critical clinical deterioration as measured by the COVID-19 scale or the natural course of recovery from typical clinical symptoms. The primary study outcome was assessed on days 14, 21, and 28 post-study entry.
Results: 321 patients were enrolled in the study, 105 of whom were randomized to receive either CBD (n = 49) or placebo (n = 42). Ninety-one participants were included in the efficacy analysis. There were no baseline differences between the groups in terms of disease severity (χ2 = 0.025, p = 0.988) and median time to symptom relief (12 days [95% confidence interval, CI, 6.5-17.5] in the CBD group, 9 days [95% CI, 4.8-13.2] in the placebo group [χ2 = 1.6, p = 0.205 by log-rank test]). By day 28, 83.3% of patients in the CBD group and 90.2% in the placebo group had symptom relief. There were no differences between groups in secondary measures. CBD was well tolerated, causing mainly mild and transient side effects (e.g., somnolence, fatigue, changes in appetite, somnolence, nausea, diarrhea, and fever), with no significant differences between the CBD and placebo treatment groups.
Conclusions and Meaning: Daily administration of 300 mg of CBD for 14 days did not change the clinical evolution of COVID-19. Further research should investigate the therapeutic effect of CBD in severe COVID-19 patients, possibly trying higher doses than those used in our study. Study registration: ClinicalTrials.gov ID NCT04467918 (registration date: July 13, 2020).
Similar articles
- The effectiveness and safety of Cannabidiol and Standard Health Care in treating emotional exhaustion and burnout among health care workers during the COVID-19: A Randomized Clinical Trial pandemic.
Safety and efficacy of imatinib in hospitalized adults with COVID-19: A structured summary of the study protocol for a randomized controlled trial.
Virtualized clinical trials evaluating the natural history and modulating effects of the gut microbiome in non-hospitalized patients with mild to moderate COVID-19 randomized, open-label, prospective parallel group study investigating the physiological effects of KB109 on the structure and function of the gut microbiota: a structured summary of the study protocol for a randomized controlled trial .
Study of the efficacy and safety of BIO101 in preventing respiratory deterioration in patients with COVID-19 pneumonia (COVA study): a structured summary of the protocol for a randomized controlled trial.
