Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777981
Status:
UNKNOWN
Last Update Posted:
2022-02-22
First Post:
2021-02-25
Brief Title:
CBDRA60 to Prevent or Reduce Symptoms of COVID-19 and Prevention of Post-Acute Sequelae of SARS-CoV-2 Infection PASC
Sponsor:
Anewsha Therapeutics Inc
Organization:
Anewsha Therapeutics Inc
Study Overview
Official Title:
Efficacy of Cannabidiol in Combination With Red Algae CBDRA60 to Prevent or Reduce Symptoms of COVID-19 and Post-Acute Sequelae of SARS-CoV-2 Infection PASC
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coronavirus disease COVID-19 caused by the novel severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 presents a major threat to human health SARS-CoV-2 is highly infectious and is associated with extensive morbidity and mortality Our study shares important features with other clinical trials using supplements or other widely available medications eg Ascorbic Acid Zinc Vitamin D Vitamin C Our study shares two important elements with these previous studies including
1 The use of adaptive and cost-effective study design methods
2 The testing of prophylactic supplementation using known natural substances that have demonstrated safety and limited side effects
The focus of this study is to use a supplement that combines Cannabidiol and Gigartina Red Algae in creating CBDRA60 a sublingual tablet which is hypothesized to help reduce the duration of symptoms in patients diagnosed with the novel coronavirus disease COVID-19 The rationale and design of our trial N60 is as follows 60 individuals newly diagnosed with COVID-19 infection will be randomized to one of two groups They will either receive CBDRA60 30mg CBD 30mgRA 60mg combo 2xdaily with food or 120 mg total or a placebo in a 11 ratio The study duration will be 5 weeks The primary outcome for newly diagnosed individuals is the prevention of disease progression which leads to hospitalization The secondary outcome is a reduction in symptom severity scores
COVID-19 patients with weakened innate immune systems may be susceptible to more severe disease and higher mortality An impaired host immune response may lead to higher SARS-COV-2 viral load and subsequent overactivation of the adaptive immune system that results in cytokine release syndrome CBD and Gigartina Red Algae can modulate both the innate and adaptive immune responses have anti-viral activity and thereby can suppress the consequent hyperinflammatory response
Viral infection activates a pathological inflammatory response to combat the pathogen and limit its spread Viral pathogens such as the severe acute respiratory syndrome SARS coronaviruses SARS-CoV and other viruses such as HIV have been linked to many human and animal diseases Advancements in research over the past decade has led to a better understanding of SARS-CoV biology and the mechanism by which this family of viruses the coronaviridae infect and enter the host cells refs SARS-CoV-2 a unique type of coronavirus inhibits host defense by invading host cells replicating and infecting numerous tissues Severe COVID-19 is associated with a cytokine storm acute respiratory distress and consequent multiple organ pathology that can be fatal This depictive storm is a result of increase in circulating levels of various proinflammatory cytokines including IL-6 IL-1 TNF-α as well as interferons IFN-I IFNα and IFNβ
CBD CBD is a non-psychotropic cannabinoid that has a broad spectrum of well-established anti-inflammatory and immunomodulatory effects For example CBD administration in a murine model of lung injury reduces lung inflammation through inhibition of immune cell cytokine production and suppression of leukocyte infiltration Our premise is that similar CBD-induced effects would be highly applicable and hugely beneficial to mitigating the acute respiratory distress syndrome observed in COVID-19 Published evidence also indicates that CBD can inhibit viral replication Red algae Rhodophyta are known for their potent anti-viral properties non-toxicity and for being well tolerated in humans Rhodophyta contain several sulfated polysaccharides that exhibit high antiviral activity against enveloped viruses including important human pathogens such as herpes simplex virus HSV human cytomegalovirus dengue virus and respiratory syncytial virus Sulfated polysaccharides can exert their anti-viral effects through interacting with the external glycoprotein of the virion envelope preventing attachment of the virus to cell surface receptors Red algae also contain mannose specific lectins that specifically interact with viral envelope glycoproteins including the spike glycoprotein specific to SARS-CoV2 to inhibit viral entry
It is our premise that by using a safe and tolerable dose of the formulated CBDRA60 sublingual tablet participants could either be protected from viral infection of the SARS-CoV-2 virus COVID-19 or in subjects that are already infected CBDRA60 could prevent virus attachment mitigate virus-induced inflammation and avoid a cytokine storm enabling a faster recovery
1 The use of adaptive and cost-effective study design methods
2 The testing of prophylactic supplementation using known natural substances that have demonstrated safety and limited side effects
The focus of this study is to use a supplement that combines Cannabidiol and Gigartina Red Algae in creating CBDRA60 a sublingual tablet which is hypothesized to help reduce the duration of symptoms in patients diagnosed with the novel coronavirus disease COVID-19 The rationale and design of our trial N60 is as follows 60 individuals newly diagnosed with COVID-19 infection will be randomized to one of two groups They will either receive CBDRA60 30mg CBD 30mgRA 60mg combo 2xdaily with food or 120 mg total or a placebo in a 11 ratio The study duration will be 5 weeks The primary outcome for newly diagnosed individuals is the prevention of disease progression which leads to hospitalization The secondary outcome is a reduction in symptom severity scores
COVID-19 patients with weakened innate immune systems may be susceptible to more severe disease and higher mortality An impaired host immune response may lead to higher SARS-COV-2 viral load and subsequent overactivation of the adaptive immune system that results in cytokine release syndrome CBD and Gigartina Red Algae can modulate both the innate and adaptive immune responses have anti-viral activity and thereby can suppress the consequent hyperinflammatory response
Viral infection activates a pathological inflammatory response to combat the pathogen and limit its spread Viral pathogens such as the severe acute respiratory syndrome SARS coronaviruses SARS-CoV and other viruses such as HIV have been linked to many human and animal diseases Advancements in research over the past decade has led to a better understanding of SARS-CoV biology and the mechanism by which this family of viruses the coronaviridae infect and enter the host cells refs SARS-CoV-2 a unique type of coronavirus inhibits host defense by invading host cells replicating and infecting numerous tissues Severe COVID-19 is associated with a cytokine storm acute respiratory distress and consequent multiple organ pathology that can be fatal This depictive storm is a result of increase in circulating levels of various proinflammatory cytokines including IL-6 IL-1 TNF-α as well as interferons IFN-I IFNα and IFNβ
CBD CBD is a non-psychotropic cannabinoid that has a broad spectrum of well-established anti-inflammatory and immunomodulatory effects For example CBD administration in a murine model of lung injury reduces lung inflammation through inhibition of immune cell cytokine production and suppression of leukocyte infiltration Our premise is that similar CBD-induced effects would be highly applicable and hugely beneficial to mitigating the acute respiratory distress syndrome observed in COVID-19 Published evidence also indicates that CBD can inhibit viral replication Red algae Rhodophyta are known for their potent anti-viral properties non-toxicity and for being well tolerated in humans Rhodophyta contain several sulfated polysaccharides that exhibit high antiviral activity against enveloped viruses including important human pathogens such as herpes simplex virus HSV human cytomegalovirus dengue virus and respiratory syncytial virus Sulfated polysaccharides can exert their anti-viral effects through interacting with the external glycoprotein of the virion envelope preventing attachment of the virus to cell surface receptors Red algae also contain mannose specific lectins that specifically interact with viral envelope glycoproteins including the spike glycoprotein specific to SARS-CoV2 to inhibit viral entry
It is our premise that by using a safe and tolerable dose of the formulated CBDRA60 sublingual tablet participants could either be protected from viral infection of the SARS-CoV-2 virus COVID-19 or in subjects that are already infected CBDRA60 could prevent virus attachment mitigate virus-induced inflammation and avoid a cytokine storm enabling a faster recovery
Detailed Description:
The trial is a randomized double blind placebo-controlled trial with a total of 60 participants located in the state of Michigan Patients will be randomized to CBDRA60 supplement or placebo
All participants will be newly diagnosed as positive for SARS-CoV2 assessed using a PCR test
Each participant will be randomized to either CBDRA60 or placebo in a 11 ratio The study duration for each participant will be 5 weeks including taking the supplementation active or placebo for 28 days Of the 60 participants 30 participants will receive CBDRA60 and 30 participants will receive the placebo The infected individuals will be followed to assess disease progression defined as the need for hospitalization
For participants receiving the CBDRA60 supplementation it aims to reduce
1 The need to be hospitalized and
2 Self-reported disease severity and resolution over 5 weeks Participants will self-report symptom severity and disease progression through weekly questionnaires For each specified COVID-19 related symptom fever cough shortness of breath or difficulty breathing fatigue muscle or body aches headache new loss of taste or smell sore throat congestion or runny nose nausea or vomiting diarrhea participants will report one of the following 3 options none score of 0 mild score of 1 moderate score of 2 or severe score of 3 except for new loss of taste or smell which will be assessed using a binary score 0 no loss of tastesmell 1 loss of tastesmell in accordance with the HHS guidelines Sep 2020 document The total disease severity score will be the average across all potential symptoms The escalation protocol for any participants that experience symptoms that are more than mild or continue to progress will be directed to contact their primary care physician or their appropriate emergency care facility
Supplementation Daily sublingual tablet containing 30mg Cannabidiol and 30mg Red Algae a total of 60mg per dose Participants will take 2 tablets per day sublingually and with food taken approximately and at least 8 hours apart daily for 28 days Participants will be mailed a supply of pills by an overnight courier service
Control subjects will receive daily oral placebo tablets of identical appearance and taste containing no CBDRA60
Study procedures Recruitment Participants will be recruited across Michigan via social media community advocacy groups and equity initiatives flyers and electronic communications distributed in healthcare centers COVID-19 testing centers and other avenues Recruitment will primarily be conducted remotely and prospective participants will be asked to complete a web-based HIPAA-secure screening survey by the MB Clinical or VSafe system Screen-eligible participants will be contacted by phone by research staff to complete the screening process using on-line consent forms
Baseline and follow-up Participants will receive messages as a reminder to take study pills They will also be instructed to complete 1x per week online questionnaires for 5 weeks and an additional post study follow-up questionnaire at week 8 The questionnaire will include items on adherence with randomized supplementation with CBDRA60placebo use of non-trial supplements of CBD development of symptoms and new illness and self-report of disease progression and severity status Non-responders to online notification will be telephoned to collect study data
Data Management Using ClinOne or VSafe Platform
ClinOne a clinical research organization CRO with a Vsafe platform will be implemented for key areas of improvement of patient engagement and retention throughout the investigation It provides remote online services between patients and the clinicians in charge It further provides services for
Required screening criteria
Questionnaires
Study contact
Recorded investigatory meetings
CEO and KOL presentation and important messages
Training videos All through a secure online platform
All the services can be accessed via the ClinOne or VSafe platform Patients will use the platform for reminders to access study information report questions or concerns and communicate with principal investigators and physician The platform allows the clinical trial leader to schedule events via its manager system SOEM It is a secure portal to share approved study documents provide a concierge and knowledge digital base research visits and ePro lite which will be used to deliver the questionnaires to patients and guarantee the collection of evaluable data For reminders on when to take the CBDRA 60 sublingual tablet an electronic eDosing adherence reminder will be available to notify the study participants
Lastly in order to monitor the subjects health remotely and to collect additional biometric data a smart BioIntelliSenses BioButton medical-grade device and HIPAA-compliance data service will be used This enables effortless remote multi-parameter data capturing that measures vital signs in real time It comprises a single disposable on-body sensor for continuous monitoring of temperature oximeter readings respiratory rate heart rate at rest body position sleep and activity state for 90-days Alternatively a similar oximeter thermometer combination will be provided
Assessed symptoms are Fever Cough Shortness of Breath Fatigue Muscle or body aches Headache New loss of taste New loss of smell Congestion or runny nose Nausea Vomiting Diarrhea Each patient will have a composite score ranging from 0-36day
1 Symptom Resolution Fever Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of fever based on a 0-3 scale 0 986oF 1 986 oF - 1004 oF 2 1004 oF - 1026 oF 3 1026 oF
2 Symptom Resolution Cough Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of cough based on a 0-2 scale 0 no cough 1 mildmoderate 2 severe How does the individual discriminate between mild and moderate
3 Symptom Resolution Shortness of Breath Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of shortness of breath based on a 0-3 scale 0 no shortness of breath 1 with moderate intensity exercise 2 with walking on flat surface 3 short of breath with getting dressed or daily activities
4 Symptom Resolution Fatigue Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of fatigue based on a 0-3 scale 0no fatigue 1mild fatigue 2moderate fatigue 3severe fatigue
5 Symptom Resolution Musclebody aches Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of musclebody aches based on a 0-3 scale 0no musclebody aches 1mild musclebody aches 2moderate musclebody aches 3severe musclebody aches
6 Symptom Resolution Headache Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of headache based on a 0-3 scale 0no headache 1mild headache 2moderate headache 3severe headache
7 Symptom Resolution New loss of taste Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of new loss of taste based on a binary scale 0no loss of taste 1 loss of taste
Symptom Resolution New loss of smell Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of new loss of smell based on a binary scale 0no loss of smell 1 loss of smell
8 Symptom Resolution Congestion runny nose Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of congestionrunny nose on a 0-3 scale 0no congestionrunny nose 1mild congestionrunny nose 2moderate congestionrunny nose 3severe congestionrunny nose
9 Symptom Resolution Nausea Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of nausea on a 0-3 scale0no nausea 1mild nausea 2moderate nausea 3severe nausea
10 Symptom Resolution Vomiting Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of vomiting on a 0-3 scale 0no vomiting 1mild vomiting 2moderate vomiting 3severe vomiting
11 Symptom Resolution Diarrhea Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of diarrhea on a 0-3 scale 0no diarrhea 1mild diarrhea 2moderate diarrhea 3severe diarrhea
12 Day 28 Composite Symptoms Time Frame 35 days Total symptom composite score at day 5 of study supplementation Symptom categories of fever based on a 0-3 scale 0 986 oF 1 986- 1006 oF 2 1006 - 1026 oF 3 102 oF Cough on a 0-3 scale 0 no cough 1 mild 2 moderate 3 severe Shortness of Breath on a 0-3 0 no shortness of breath 1 with moderate intensity exercise 2 with walking on flat surface 3 short of breath with getting dressed or daily activities and Fatigue on a 0-3 scale 0 No fatigueenergetic 1mild fatigue 2moderate fatigue 3severe fatigue
13 HospitalizationsER visits Time Frame 35 days Differences in hospitalization ER visits mortality events between the study arms
14 Severity of Symptoms Time Frame 35 days Differences in severity of symptoms between study arms
15 Adjunctive Medications Time Frame 35 days Differences in number of patients who were prescribed adjunctive medications for their diagnosis between study arms
16 Supplementation Side Effects Time Frame 35 days Differences in number of patients in study arms who experienced side effects from the supplements
All participants will be newly diagnosed as positive for SARS-CoV2 assessed using a PCR test
Each participant will be randomized to either CBDRA60 or placebo in a 11 ratio The study duration for each participant will be 5 weeks including taking the supplementation active or placebo for 28 days Of the 60 participants 30 participants will receive CBDRA60 and 30 participants will receive the placebo The infected individuals will be followed to assess disease progression defined as the need for hospitalization
For participants receiving the CBDRA60 supplementation it aims to reduce
1 The need to be hospitalized and
2 Self-reported disease severity and resolution over 5 weeks Participants will self-report symptom severity and disease progression through weekly questionnaires For each specified COVID-19 related symptom fever cough shortness of breath or difficulty breathing fatigue muscle or body aches headache new loss of taste or smell sore throat congestion or runny nose nausea or vomiting diarrhea participants will report one of the following 3 options none score of 0 mild score of 1 moderate score of 2 or severe score of 3 except for new loss of taste or smell which will be assessed using a binary score 0 no loss of tastesmell 1 loss of tastesmell in accordance with the HHS guidelines Sep 2020 document The total disease severity score will be the average across all potential symptoms The escalation protocol for any participants that experience symptoms that are more than mild or continue to progress will be directed to contact their primary care physician or their appropriate emergency care facility
Supplementation Daily sublingual tablet containing 30mg Cannabidiol and 30mg Red Algae a total of 60mg per dose Participants will take 2 tablets per day sublingually and with food taken approximately and at least 8 hours apart daily for 28 days Participants will be mailed a supply of pills by an overnight courier service
Control subjects will receive daily oral placebo tablets of identical appearance and taste containing no CBDRA60
Study procedures Recruitment Participants will be recruited across Michigan via social media community advocacy groups and equity initiatives flyers and electronic communications distributed in healthcare centers COVID-19 testing centers and other avenues Recruitment will primarily be conducted remotely and prospective participants will be asked to complete a web-based HIPAA-secure screening survey by the MB Clinical or VSafe system Screen-eligible participants will be contacted by phone by research staff to complete the screening process using on-line consent forms
Baseline and follow-up Participants will receive messages as a reminder to take study pills They will also be instructed to complete 1x per week online questionnaires for 5 weeks and an additional post study follow-up questionnaire at week 8 The questionnaire will include items on adherence with randomized supplementation with CBDRA60placebo use of non-trial supplements of CBD development of symptoms and new illness and self-report of disease progression and severity status Non-responders to online notification will be telephoned to collect study data
Data Management Using ClinOne or VSafe Platform
ClinOne a clinical research organization CRO with a Vsafe platform will be implemented for key areas of improvement of patient engagement and retention throughout the investigation It provides remote online services between patients and the clinicians in charge It further provides services for
Required screening criteria
Questionnaires
Study contact
Recorded investigatory meetings
CEO and KOL presentation and important messages
Training videos All through a secure online platform
All the services can be accessed via the ClinOne or VSafe platform Patients will use the platform for reminders to access study information report questions or concerns and communicate with principal investigators and physician The platform allows the clinical trial leader to schedule events via its manager system SOEM It is a secure portal to share approved study documents provide a concierge and knowledge digital base research visits and ePro lite which will be used to deliver the questionnaires to patients and guarantee the collection of evaluable data For reminders on when to take the CBDRA 60 sublingual tablet an electronic eDosing adherence reminder will be available to notify the study participants
Lastly in order to monitor the subjects health remotely and to collect additional biometric data a smart BioIntelliSenses BioButton medical-grade device and HIPAA-compliance data service will be used This enables effortless remote multi-parameter data capturing that measures vital signs in real time It comprises a single disposable on-body sensor for continuous monitoring of temperature oximeter readings respiratory rate heart rate at rest body position sleep and activity state for 90-days Alternatively a similar oximeter thermometer combination will be provided
Assessed symptoms are Fever Cough Shortness of Breath Fatigue Muscle or body aches Headache New loss of taste New loss of smell Congestion or runny nose Nausea Vomiting Diarrhea Each patient will have a composite score ranging from 0-36day
1 Symptom Resolution Fever Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of fever based on a 0-3 scale 0 986oF 1 986 oF - 1004 oF 2 1004 oF - 1026 oF 3 1026 oF
2 Symptom Resolution Cough Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of cough based on a 0-2 scale 0 no cough 1 mildmoderate 2 severe How does the individual discriminate between mild and moderate
3 Symptom Resolution Shortness of Breath Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of shortness of breath based on a 0-3 scale 0 no shortness of breath 1 with moderate intensity exercise 2 with walking on flat surface 3 short of breath with getting dressed or daily activities
4 Symptom Resolution Fatigue Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of fatigue based on a 0-3 scale 0no fatigue 1mild fatigue 2moderate fatigue 3severe fatigue
5 Symptom Resolution Musclebody aches Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of musclebody aches based on a 0-3 scale 0no musclebody aches 1mild musclebody aches 2moderate musclebody aches 3severe musclebody aches
6 Symptom Resolution Headache Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of headache based on a 0-3 scale 0no headache 1mild headache 2moderate headache 3severe headache
7 Symptom Resolution New loss of taste Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of new loss of taste based on a binary scale 0no loss of taste 1 loss of taste
Symptom Resolution New loss of smell Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of new loss of smell based on a binary scale 0no loss of smell 1 loss of smell
8 Symptom Resolution Congestion runny nose Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of congestionrunny nose on a 0-3 scale 0no congestionrunny nose 1mild congestionrunny nose 2moderate congestionrunny nose 3severe congestionrunny nose
9 Symptom Resolution Nausea Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of nausea on a 0-3 scale0no nausea 1mild nausea 2moderate nausea 3severe nausea
10 Symptom Resolution Vomiting Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of vomiting on a 0-3 scale 0no vomiting 1mild vomiting 2moderate vomiting 3severe vomiting
11 Symptom Resolution Diarrhea Time Frame 35 days The number of days required to reach a score of 0 from the symptom category of diarrhea on a 0-3 scale 0no diarrhea 1mild diarrhea 2moderate diarrhea 3severe diarrhea
12 Day 28 Composite Symptoms Time Frame 35 days Total symptom composite score at day 5 of study supplementation Symptom categories of fever based on a 0-3 scale 0 986 oF 1 986- 1006 oF 2 1006 - 1026 oF 3 102 oF Cough on a 0-3 scale 0 no cough 1 mild 2 moderate 3 severe Shortness of Breath on a 0-3 0 no shortness of breath 1 with moderate intensity exercise 2 with walking on flat surface 3 short of breath with getting dressed or daily activities and Fatigue on a 0-3 scale 0 No fatigueenergetic 1mild fatigue 2moderate fatigue 3severe fatigue
13 HospitalizationsER visits Time Frame 35 days Differences in hospitalization ER visits mortality events between the study arms
14 Severity of Symptoms Time Frame 35 days Differences in severity of symptoms between study arms
15 Adjunctive Medications Time Frame 35 days Differences in number of patients who were prescribed adjunctive medications for their diagnosis between study arms
16 Supplementation Side Effects Time Frame 35 days Differences in number of patients in study arms who experienced side effects from the supplements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None