Plant-based Phytocannabinoids in the Management of COVID-19 Respiratory Function and Hyper- inflammation 

 

Research proposal: Testing the potential of plant-based phytocannabinoids in the management of individuals suffering from coronavirus 2 (SARS-CoV-2)  COVID 19 associated respiratory symptoms including acute respiratory distress syndrome (ARDS).

 

Research question: What if any is the impact of cannabinoids on the individual suffering with  COVID 19 associated respiratory symptoms including Severe Acute Respiratory Distress Syndrome.

 

Study Type:  Descriptive nature of the study.

Interventional   (Clinical Trial n-of-1 study)        

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Institutional Review: 

Prior  to initiating the study and  data collection, a waiver will be  obtained from the hospital  review board.

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Study Design and intervention: The study consists of an intervention that is utilized in individuals suffering from respiratory symptoms due to COVID 19 and who may require or receive ventilation support. Regulated plant-based phytocannabinoids available through certified growers are utilized in vapor form for inhalation and tincture for systemic delivery. The composition of the cannabis, as well as the administration tools, will be monitored. 

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Patients with confirmed SARS-CoV-2 infection (positive result by polymerase chain reaction testing of a nasopharyngeal sample).

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Deidentified patient data were collected and analyzed using Stata version 15.1 (StataCorp).

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Enrollment is stratified according to the severity of illness as indicated by the pulmonary function tests and level of ventilatory support administered. 

Basic clinical, social and environmental data will be collected. (Smoking, environmental and other social factors)   

All patients are screened for pulmonary function  and hyperinflammation indicators using laboratory trends (eg, increasing ferritin, decreasing platelet counts, or erythrocyte sedimentation rate) 

HScore11 (table) to identify the subgroup of patients for whom immunosuppression could improve mortality. 

 

Plant-based phytocannabinoids at three natural ratios in the plant:  High THC, High CBD 20:1, THC/CBD 1:1 will be prepared and would be administered with tincture for systemic effect and or vape for direct administration in the lung. Other ratios will be considered based on results. 

The phytocannabinoids will be administered at times intervals that appear clinically indicated. (For example, if an initial benefit is noted, a dose can be administered when the effect is diminished) 

 

Endpoint: The primary endpoint is the time to clinical improvement, defined as the time to improved pulmonary function. ICU, need for mechanical ventilation, discharge from the hospital or improvement on a multifactorial set of preselected criteria, or death. 

 

Participants/Eligibility Criteria : Individuals who are hospitalized due to COVID 19 associated respiratory problems and may and or require ventilation support. 

 

Inclusion Criteria: All individuals suffering from COVID 19 associated respiratory problems  who are positive for SARS-CoV-2 by nasopharyngeal swab 

 

Specifics of respiratory function: 02 saturation, dyspnea, fever 

 

• Patients who had an oxygen saturation of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen of less than 300 mm Hg and who were receiving a range of ventilatory support modes, from nothing to mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 

 

Exclusion Criteria:

Refusal of family 

Refusal by clinical staff 

 

Baseline information and assessment:

Age

Ethnicity 

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Medical history

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Medication use

 

General vital signs

BP

Fever

Respiration

 

Pulmonary  function

Chest XRay

O2

Airway conductance

Peak flow measurements

FEV

Bronchospasm 

 

Laboratory

Neutrophils 

Ferritin

Sed Rate 

 

Social/ Environmental

Smoking history

Exposure to pollution

Exposure to cannabis

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Gross Clinical Outcome Measures: 

 

Time clinical improvement

Hospital Discharge 

Death

Long term lung/ respiratory damage

 

Assessment of Adverse Events

 

Data collection and  Analysis:

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Challenges for Research:

 

1. Regulatory 

2. Staff (Need to maintain safety)

3. Data collection logistics and reliability 

3. Logistics and availability of plant-based phytocannabinoids

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