Cannabidiol for COVID-19 Patients with Mild to Moderate Symptoms (CANDIDATE Study): A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Crippa et al.,
Cannabidiol for COVID-19 Patients with Mild to Moderate Symptoms (CANDIDATE Study): A Randomized,..,
Cannabis and Cannabinoid Research, doi:10.1089/can.2021.0093
RCT 105 patients recruited in an ER in Brazil, 49 treated with CBD, showing no significant differences with treatment. 300mg CBD for 14 days.
For discussion see
[liebertpub.com].
risk of hospitalization, 557.1% higher, RR 6.57, p = 0.25, treatment 3 of 49 (6.1%), control 0 of 42 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
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recovery time, 33.3% higher, relative time 1.33, p = 0.20, treatment 49, control 42.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Crippa et al., 7 Oct 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Brazil, peer-reviewed, 32 authors, study period 7 July, 2020 - 16 October, 2020.
Abstract: Cannabis and Cannabinoid Research
Volume X, Number X, 2021
ª Mary Ann Liebert, Inc.
DOI: 10.1089/can.2021.0093
Cannabidiol for COVID-19 Patients with Mild
to Moderate Symptoms (CANDIDATE Study):
A Randomized, Double-Blind, Placebo-Controlled
Clinical Trial
José Alexandre S. Crippa,1,2,*,i 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 and Jaime E.C. Hallak1,2; for the Cannabidiol for COVID-19
Patients (CANDIDATE) Trial Investigators
Abstract
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 Ribeirão 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 (v2 = 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,
1
Department of Neuroscience and Behavior, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.
National Institute for Science and Technology—Translational Medicine, São Paulo, Brazil.
3
Department of Pharmacology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.
4
Department of Medicinal Chemistry and Natural Products, The Institute for Drug Research, School of Pharmacy, The Hebrew University of Jerusalem, Jerusalem, Israel.
5
Department of Psychiatry and..
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