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The potential of cannabidiol in the COVID-19 pandemic

Affiliations

  • 1 Department of Physiology and Pharmacology “V. Erspamer”, Sapienza University of Rome, Rome, Italy.
  • 2 Department of Clinical Medicine and Surgery, University of Naples “Federico II”, Naples, Italy.
  • 3 Sequentia Biotech SL, Barcelona, Spain.
  • 4 Department of Human Anatomy, College of Basic Medical Sciences, China Medical University, Shenyang, China.
  • PMID: 32519753
  • PMCID: PMC7300643
  • DOI: 10.1111/bph.15157

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The potential of cannabidiol in the COVID-19 pandemic

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Authors

Affiliations

  • 1 Department of Physiology and Pharmacology “V. Erspamer”, Sapienza University of Rome, Rome, Italy.
  • 2 Department of Clinical Medicine and Surgery, University of Naples “Federico II”, Naples, Italy.
  • 3 Sequentia Biotech SL, Barcelona, Spain.
  • 4 Department of Human Anatomy, College of Basic Medical Sciences, China Medical University, Shenyang, China.
  • PMID: 32519753
  • PMCID: PMC7300643
  • DOI: 10.1111/bph.15157

Abstract

Identifying drugs effective in the new coronavirus disease 2019 (COVID-19) is crucial, pending a vaccine against SARS-CoV2. We suggest the hypothesis that cannabidiol (CBD), a non-psychotropic phytocannabinoid, has the potential to limit the severity and progression of the disease for several reasons:- (a) High-cannabidiol Cannabis sativa extracts are able to down-regulate the expression of the two key receptors for SARS-CoV2 in several models of human epithelia, (b) cannabidiol exerts a wide range of immunomodulatory and anti-inflammatory effects and it can mitigate the uncontrolled cytokine production responsible for acute lung injury, (c) being a PPARγ agonist, it can display a direct antiviral activity and (d) PPARγ agonists are regulators of fibroblast/myofibroblast activation and can inhibit the development of pulmonary fibrosis, thus ameliorating lung function in recovered patients. We hope our hypothesis, corroborated by preclinical evidence, will inspire further targeted studies to test cannabidiol as a support drug against the COVID-19 pandemic. LINKED ARTICLES: This article is part of a themed issue on The Pharmacology of COVID-19. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v177.21/issuetoc.

© 2020 The British Pharmacological Society.

Conflict of interest statement

The authors declare no conflicts of interest.

Figures

The potential of cannabidiol (CBD)…

The potential of cannabidiol (CBD) in SARS‐CoV2 infection. Cannadibidiol recognizes several receptor targets…

Identifying drugs effective in the new coronavirus disease 2019 (COVID-19) is crucial, pending a vaccine against SARS-CoV2. We suggest the hypothesis that cannabidiol (CBD), a non-psychotropic phytocannabinoid, has the potential to limit the severity and progression of the disease for several reason …

CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms (CANDIDATE)

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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.

Condition or disease Intervention/treatment Phase
SARS-CoV2 Drug: Cannabidiol Other: PLACEBO Phase 2 Phase 3

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 use random stratification by minimizing the sample to stratify all eligible patients according to gender, age, disease severity (mild or moderate) and presence of comorbidity (controlled diabetes and/or hypertension), followed by random designation (in a ratio 1: 1) in each stratum to ensure a balanced distribution of disease severity among treatment groups (CBD plus symptomatic clinical and pharmacological measures) and control (symptomatic clinical and pharmacological measures and placebo). 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 (https://portalarquivos.saude.gov.br/images/pdf /2020/April/18/Dirursos-Covid19.pdf). In other words, the following pharmacological measures: “prescription of drugs for symptom control, if there is no contraindication, with the possibility of intercalating antipyretic drugs in cases of difficult control of fever. • Oral antipyretic: 1st option: Paracetamol 500-1000 mg/dose (maximum 3mg / day) • 2nd option: Dipyrone 500-1000 mg VO (maximum dose in adults 4 grams)”, and clinical measures:” Home isolation by 14 days from the date of onset of symptoms; review every 48 hours, preferably by phone, providing face-to-face assistance, if necessary; maintain rest, a balanced diet and a good supply of fluids; isolation from home contacts for 14 days”.

Thus, all patients will receive clinical and pharmacological measures of symptoms. Patients in the investigational treatment group will also receive CBD within 24 hours after randomization, with a daily dose of 300mg / day (two 150mg doses; 1mL of the formulation) for 14 days. 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, using a dosing device/syringe indistinguishable from the CBD medication. Patients, nursing staff, laboratory technicians, doctors who will carry out the assessments, researchers, and statisticians will be blind to the treatment group and will not know about the treatment information.

Secretions from the upper respiratory tract, lower respiratory tract, or both, by swab, will be obtained from each patient in the screening (day -3 to day 1) during treatment and post-treatment follow-up at the patient’s home on days 1, 2, 3, 4, 5, 7, 10, 14, 21, and 28, to test the viral load and SARS-CoV-2 genotyping. On all these dates, nurses will visit home to collect swab (only from the oropharynx, to minimize discomfort), blood and will be evaluated at each visit for vital signs, pulse oximetry, odor test, and treatment guidelines. Each patient will also receive a digital thermometer to measure the axillary temperature in case of suspected fever and daily measurement immediately before lunch and dinner.

CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms (CANDIDATE) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.