COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04777981

Erin Swartout, MA

erin@anewsha.com

2021-03-02

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

- 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.

2

Anewsha Therapeutics Inc.

18

100

United States

Mild disease at enrollment

1: Mild disease at enrollment

60

Decreased hospitalization

None

Not reported

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