Cannabidiol for COVID-19 Patients with Mild to Moderate Symptoms (CANDIDATE Study): A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
José Alexandre S Crippa, Julia Cozar Pacheco, Antonio W Zuardi, Francisco S Guimarães, Alline Cristina Campos, Flávia De Lima Osório, Sonia Regina Loureiro, Rafael G Dos Santos, José Diogo S Souza, Juliana Mayumi Ushirohira, Rafael Rinaldi Ferreira, Karla Cristinne Mancini Costa, Davi Silveira Scomparin, Franciele Franco Scarante, Isabela Pires-Dos-Santos, Raphael Mechoulam, Flávio Kapczinski, Benedito A L Fonseca, Danillo L A Esposito, Afonso Dinis Costa Passos, Amaury Lelis Dal Fabbro, Fernando Bellissimo-Rodrigues, Eurico Arruda, Sandro Scarpelini, Maristela Haddad Andraus, Julio Cesar Nather Junior, Danilo Tadao Wada, Marcel Koenigkam-Santos, Antonio Carlos Santos, Geraldo Busatto Filho, Jaime E C Hallak
Cannabis and Cannabinoid Research, doi:10.1089/can.2021.0093
Importance: Owing to its anti-inflammatory properties and antiviral ''in vitro'' effect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), cannabidiol (CBD) has been proposed as a potential treatment for coronavirus disease 2019 (COVID-19). Objective: To investigate the safety and efficacy of CBD for 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, in two sites in Brazil. Setting: Patients were recruited in an emergency room. Participants: Block randomized patients (1:1 allocation ratio-by a researcher not directly involved in data collection) with mild and moderate COVID-19 living in Ribeira ˜o Preto, Brazil, seeking medical consultation, and those who voluntarily agreed to participate in the study. Interventions: Patients received 300 mg of CBD or placebo added to standard symptomatic care during 14 days. Main Outcome and Measure: The primary outcome was reduction or prevention of the deterioration in clinical status from mild/moderate to severe/critical measured with the COVID-19 Scale or the natural course of the resolution of typical clinical symptoms. Primary study outcome was assessed on days 14, 21, and 28 after enrollment. Results: A total of 321 patients were recruited and assessed for eligibility, and 105 were randomly allocated either in CBD (n = 49) or in placebo (n = 42) group. Ninety-one participants were included in the analysis of efficacy. There were no baseline between-group differences regarding disease severity (v 2 = 0.025, p = 0.988) and median time to symptom resolution (12 days [95% confidence interval, CI, 6.5-17.5] in the CBD group, 9 days [95% CI,
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