Status:
UNKNOWN
(CBDRA60) to Prevent or Reduce Symptoms of COVID-19 and Prevention of Post-Acute Sequelae of SARS-CoV-2 Infection PASC
Lead Sponsor:
Anewsha Therapeutics Inc.
Collaborating Sponsors:
University of Michigan
Biologics Consulting
Conditions:
COVID-19
SAR
Eligibility:
All Genders
18+ years
Phase:
NA
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 associ...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04777981
Start Date
July 1 2022
End Date
December 28 2022
Last Update
February 22 2022
Active Locations (1)
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1
Anewsha Therapeutics / Comco R&D
Hanover, Michigan, United States, 49250