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(CBDRA60) to Prevent or Reduce Symptoms of COVID-19 and Prevention of Post-Acute Sequelae of SARS-CoV-2 Infection PASC

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ClinicalTrials.gov Identifier: NCT04777981
Recruitment Status : Not yet recruiting
First Posted : March 2, 2021
Last Update Posted : March 8, 2021
Sponsor:
Collaborators:
University of Michigan
Biologics Consulting
Information provided by (Responsible Party):
Anewsha Therapeutics Inc.

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 (e.g., 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 (N=60), 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; 2x/daily with food or 120 mg total) or a placebo in a 1:1 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.


Condition or disease Intervention/treatment Phase
COVID-19 SAR Dietary Supplement: CBDRA60 supplement Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, double blind, placebo-controlled trial. Patients will be randomized to CBDRA60 supplement or placebo.
Masking: Double (Participant, Investigator)
Masking Description: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : May 5, 2021
Estimated Study Completion Date : May 28, 2021

Arm Intervention/treatment
Experimental: CBDRA60 supplement
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.
Dietary Supplement: CBDRA60 supplement
CBD is a non-psychotropic cannabinoid that has a broad spectrum of well-established anti-inflammatory and immunomodulatory effects. Red algae (Rhodophyta) are known for their potent anti-viral properties, non-toxicity and for being well tolerated in humans [15, 16]. Rhodophyta contain several sulfated polysaccharides that exhibit high antiviral activity against enveloped viruses.,
Other Name: CBDRA60

Placebo Comparator: Placebo
Control subjects will receive daily oral placebo tablets of identical appearance and taste containing no CBDRA60.
Dietary Supplement: Placebo
Placebo




Primary Outcome Measures :
  1. Decreased hospitalization [ Time Frame: 35 days ]
    Number of participants hospitalized and/or requiring repeat emergency room visit from COVID-19 related complications.


Secondary Outcome Measures :
  1. Resolution of COVID-19 symptoms [ Time Frame: 35 days ]

    Time at which the patient is completely symptom free. Number of days to reach a 30-50 percent change in the cumulative 0-36 symptom score with each symptom evaluated on a 0-3 scale. Lower is better, higher is worse 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 0-36/day.

    Example symptom resolution: Shortness of Breath [Time Frame: 35 days] 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The study population will include individuals who tested positive for COVID-19 infection based on a PCR test. The study population is defined as adults ≥ 18 years of age with no comorbidities and absence of pre-existing conditions (see exclusion criteria below).

  • Baseline drug screen for schedule 1 narcotics
  • All participants are required to understand and provide informed consent before any assessment is performed
  • Be willing and able to complete an online questionnaire
  • Be able to understand and agrees to comply with planned study procedures and be available for all study visits
  • Participants who have received the Pfizer or Moderna vaccine are allowed to be enrolled in study if they have a PCR positive test

Exclusion Criteria:

  • Current hospitalization
  • Participation in any other COVID-19 trial
  • Individuals that are taking antiviral medications
  • Baseline lab/drug screen shows consumption of a schedule 1 narcotic
  • Prior diagnosis of cancer and currently undergoing radiation, chemotherapy, or immunotherapy; excluding basal cell skin carcinoma
  • Participants who have been diagnosed as HIV positive or taking anti-HIV therapy
  • Female participants who are pregnant or breastfeeding, lactating, or planning a pregnancy during the trial.
  • Female subjects who is/are breastfeeding or plans to breastfeed
  • Medical disease or conditions such as high-risk comorbidities such as: diabetes, chronic obstructive pulmonary disease (COPD) or emphysema, history of heart attack or stroke, history of coronary bypass surgery or coronary angioplasty or stent, history of hospitalization for heart failure, etc.
  • Demonstrated inability to comply, tell the truth (as defined by PI, study investigator on subjects health condition) with the study procedures
  • History of hypersensitive or severe allergic reactions
  • Anticipated need for immunosuppressive treatment within the next 6 months
  • Received immunoglobulins and or any blood or blood products within the 4 months of being enrolled in this investigation
  • Blood dyscrasias or significant disorder of coagulation.
  • Severe Liver disease including chronic liver disease, fatty liver, cirrhosis or awaiting transplant.
  • History of alcohol abuse or other recreational drug abuse of schedule 1 narcotics within 6 months of being enrolled in the study.
  • Subjects diagnosed with:

    • Kidney disease (CKD) | End-Stage Renal Disease (ESRD) or dialysis.
    • A history of Calcium Oxalate kidney stones
    • Mineral bone disorders.

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): NCT04777981


Contacts
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Contact: Erin Swartout, MA 7039457066 erin@anewsha.com
Contact: Director chris@anewsha.com

Locations
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United States, Michigan
Anewsha Therapeutics / Comco R&D
Hanover, Michigan, United States, 49250
Contact: Erin Swartout, MA    703-945-7066    erin@anewsha.com   
Sponsors and Collaborators
Anewsha Therapeutics Inc.
University of Michigan
Biologics Consulting
Investigators
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Principal Investigator: Eleni Stylianou, PHD Anewsha Therapeutics
Publications:
Miranda-Massari JR, González MJ, Marcial-Vega VA, Soler JD: A Possible Role for Ascorbic Acid in COVID-19. Journal of Restorative Medicine 2020, 10.
Bourgougnon N, Lahaye M, Quemener B, Chermann J, Rimbert M, Cormaci M, Furnari G, Kornprobst J: Annual variation in composition andin vitro anti-HIV-1 activity of the sulfated glucuronogalactan fromSchizymenia dubyi (Rhodophyta, Gigartinales). Journal of applied phycology 1996, 8:155-161
Pujol CA, Carlucci MJ, Matulewicz MC, Damonte EB: Natural sulfated polysaccharides for the prevention and control of viral infections. In Bioactive Heterocycles V. Springer; 2007: 259-281

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Responsible Party: Anewsha Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04777981    
Other Study ID Numbers: 1001
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection