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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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04467918
Recruitment Status : Active, not recruiting
First Posted : July 13, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Jose Alexandre de Souza Crippa, University of Sao Paulo

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.


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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cannabidiol (CBD) in Patients With Mild to Moderate Symptoms of Coronavirus 2019: A Randomized, Double-blind, Placebo-controlled Clinical Trial
Actual Study Start Date : July 6, 2020
Estimated Primary Completion Date : November 16, 2020
Estimated Study Completion Date : December 16, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: Cannabidiol (CBD)
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
Already described
Other Name: CBD

Placebo Comparator: Placebo (PLB)
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
Already described
Other Name: PLB




Primary Outcome Measures :
  1. Prevention of severe/critical stage of Covid19 [ Time Frame: Up to 28 days ]
    Deterioration in clinical status from mild/moderate to severe/critical over time during the study period

  2. Time to CoVid19 symptoms relief and number of participants with negative Clinical CoVid19 symptoms as assessed by CTCAE v5.0 [ Time Frame: Up to 28 days ]
    Clinical CoVid19 symptoms Clinical improvement


Secondary Outcome Measures :
  1. Change in proinflammatory cytokine concentration [ Time Frame: Up to 28 days ]
    Immune reaction

  2. Describe the parenchymal lung damage induced by COVID-19 through a qualitative analysis with chest CT [ Time Frame: 14 days ]
    A qualitative CT analysis of parenchymal lung damage induced by COVID-19

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 28 days ]
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  4. Time to clinical improvement with CTCAE v5.0 CoVid19 symptoms to 0 [ Time Frame: Up to 28 days ]
    Time to clinical improvement

  5. Number of participants that need hospitalisation [ Time Frame: Up to 28 days ]
    CoVid severity worsening

  6. 28-day mortality [ Time Frame: Up to 28 days ]
    Mortality

  7. Time to positive-to-negative saliva 2019-n-CoV RT-PCR conversion [ Time Frame: Up to 28 days ]
    Time to negative saliva

  8. Reduction in viral load [ Time Frame: Up to 28 days ]
    Mean reduction in viral load (reduction of ≥1 log10) over time during the study period

  9. Brief measure for assessing generalized anxiety disorder and depression [ Time Frame: Through study completion, over time during the study period (day 0-28)] ]
    Brief measure for assessing generalized anxiety disorder (The GAD-7) and depression (PHQ-9)

  10. Increment of odor detection sensitivity [ Time Frame: Through study completion, over time during the study period (day 0-28)] ]
    Scores of the brief peanut butter olfactory test (Univ Florida)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Pneumonia assessed clinically and / or radiologically will not be mandatory for inclusion
  3. Have a telephone (cellular or landline) that may be available to receive daily calls throughout the study period.
  4. Willingness to voluntarily participate in the study to accept randomization for either treatment arm.
  5. Signing of the approved Free and Informed Consent Form (ICF) by the Research Ethics Committee (CEP) and CONEP

Exclusion Criteria:

  1. Age below 18 years
  2. Patients who do not want or can fulfill the necessary home isolation for at least 14 days
  3. 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
  4. 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
  5. Inability to use oral medication
  6. Pregnancy or lactation
  7. History of alcohol or drug addiction
  8. Smoking in the last three years
  9. Marijuana use in the last three months
  10. Inability to cooperate with researchers due to cognitive impairment or mental state
  11. Patients with severe forms of SARS-CoV-2, (on screening, inclusion or initial visit)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467918


Locations
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Brazil
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, SP, Brazil, 14049-900
Unidade de Pronto Atendimento/UPA - 13 de Maio/Dr. Luis Atílio Losi Viana (UPA Covid)
Ribeirão Preto, São Paulo, Brazil, 14090-270
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Jose ALEXANDRE DE S CRIPPA, MD, PhD University of Sao Paulo
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Responsible Party: Jose Alexandre de Souza Crippa, Professor of Psychiatry, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04467918    
Other Study ID Numbers: CANDIDATE study
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Alexandre de Souza Crippa, University of Sao Paulo:
SARS-CoV2; Cannabidiol
Additional relevant MeSH terms:
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Epidiolex
Anticonvulsants