CANnabiDiol for CoviD-19 pATiEnts With Mild to Moderate Symptoms (CANDIDATE)
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|ClinicalTrials.gov Identifier: NCT04467918|
Recruitment Status : Active, not recruiting
First Posted : July 13, 2020
Last Update Posted : November 3, 2020
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|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|
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.
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 Name: PLB
- 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
- 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
- Change in proinflammatory cytokine concentration [ Time Frame: Up to 28 days ]Immune reaction
- 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
- 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]
- Time to clinical improvement with CTCAE v5.0 CoVid19 symptoms to 0 [ Time Frame: Up to 28 days ]Time to clinical improvement
- Number of participants that need hospitalisation [ Time Frame: Up to 28 days ]CoVid severity worsening
- 28-day mortality [ Time Frame: Up to 28 days ]Mortality
- Time to positive-to-negative saliva 2019-n-CoV RT-PCR conversion [ Time Frame: Up to 28 days ]Time to negative saliva
- 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
- 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)
- 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)
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
|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|
|Principal Investigator:||Jose ALEXANDRE DE S CRIPPA, MD, PhD||University of Sao Paulo|