CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms

NCT04467918 | Unknown Phase 2 DMC

• 1 other identifier: CANDIDATE study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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-CoV-2. The specific objectives are to assess whether, in patients with mild and moderate forms of SARS-CoV-2, daily use of CBD 300 mg for fourteen days is capable of: i) decrease viral load; ii) modify inflammatory parameters, such as cytokines, measured from serum; iii) reduce clinical and emotional symptoms through daily clinical evaluation; iv) improve sleep; v) reduce hospitalization and worsen the severity of the disease; v) Monitor the possible adverse effects of CBD use in these patients.

Conditions

SARS-CoV2

Keywords

SARS-CoV2; Cannabidiol

Outcome Measures

Primary Outcomes (2)

• Prevention of severe/critical stage of Covid19

  Deterioration in clinical status from mild/moderate to severe/critical over time during the study period

  Up to 28 days

• Time to CoVid19 symptoms relief and number of participants with negative Clinical CoVid19 symptoms as assessed by CTCAE v5.0

  Clinical CoVid19 symptoms Clinical improvement

  Up to 28 days

Secondary Outcomes (10)

• Change in proinflammatory cytokine concentration

  Up to 28 days

• Describe the parenchymal lung damage induced by COVID-19 through a qualitative analysis with chest CT

  14 days

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Up to 28 days

• Time to clinical improvement with CTCAE v5.0 CoVid19 symptoms to 0

  Up to 28 days

• Number of participants that need hospitalisation

  Up to 28 days

Study Arms (2)

Cannabidiol (CBD)

EXPERIMENTAL

50 cases in the CBD group plus pharmacological and clinical measures. Patients in the investigational treatment group will receive CBD within 24 hours after randomization, with a daily dose of 300mg / day (two 150mg doses; 1mL of the formulation) for 14 days.

Drug: Cannabidiol

Placebo (PLB)

PLACEBO COMPARATOR

50 in the placebo group plus pharmacological and clinical measures. Patients in the placebo group will also receive, within 24 hours after randomization, 1mL of the same investigational medication vehicle (medium / coconut chain triglyceride oil - MCT) for 14 days

Other: PLACEBO

Interventions

Cannabidiol DRUG

Already described

Also known as: CBD

Cannabidiol (CBD)

PLACEBO OTHER

Already described

Also known as: PLB

Placebo (PLB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (2)

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, 14049-900, Brazil

Location

Unidade de Pronto Atendimento/UPA - 13 de Maio/Dr. Luis Atílio Losi Viana (UPA Covid)

Ribeirão Preto, São Paulo, 14090-270, Brazil

Location

Related Publications (1)

• Crippa JAS, Pacheco JC, Zuardi AW, Guimaraes FS, Campos AC, Osorio FL, Loureiro SR, Dos Santos RG, Souza JDS, Ushirohira JM, Ferreira RR, Mancini Costa KC, Scomparin DS, Scarante FF, Pires-Dos-Santos I, Mechoulam R, Kapczinski F, Fonseca BAL, Esposito DLA, Passos ADC, Dal Fabbro AL, Bellissimo-Rodrigues F, Arruda E, Scarpelini S, Andraus MH, Nather Junior JC, Wada DT, Koenigkam-Santos M, Santos AC, Busatto Filho G, Hallak JEC. Cannabidiol for COVID-19 Patients with Mild to Moderate Symptoms (CANDIDATE Study): A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Cannabis Cannabinoid Res. 2022 Oct;7(5):658-669. doi: 10.1089/can.2021.0093. Epub 2021 Oct 7.

  PMID: 34619044 DERIVED

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Jose ALEXANDRE DE S CRIPPA, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, MD, PhD

Model Details: A total of 104 patients with SARS-CoV-2 infection will be included in the study (i.e., 52 cases in the CBD group plus pharmacological and clinical measures and 52 in the placebo group plus pharmacological and clinical measures). All patients will receive the clinical and pharmacological measures standardized by the Brazilian Ministry of Health's practical guidelines for diagnosis and treatment for mild and moderate cases for SARS-CoV-2

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 13, 2020
• Study Start: July 6, 2020
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately the following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. Depending on the level of the proposed use of data, approval by an independent review committee will be required for the identified purpose.

Locations

BR (2)