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Trial - NCT04667247


Column Value
Trial registration number NCT04667247
Full text link
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04667247

First author
Last imported at : April 13, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Andrew Shubov

Contact
Last imported at : April 13, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

2020-12-14

Recruitment status
Last imported at : April 13, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - positive covid-19 diagnosis within the prior 72 hours - age 18 years and older - women of childbearing potential must have a negative urine or serum hcg. women of childbearing potential must have a negative serum pregnancy test at screening and agree to use contraception throughout the study period. - capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team - willing to avoid alcohol, cannabis, and dairy products during the study period.

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

any of the following symptoms which, according to the cdc, require hospitalization: trouble breathing persistent pain or pressure in the chest new confusion or inability to arouse bluish lips or face current use of investigational agents to prevent or treat covid-19 known liver disease (alt/ast >3x uln or diagnosis of cirrhosis) known renal disease (egfr < 60 ml/min) or acute nephritis. uncontrolled hypertension (sbp>140 or dbp>90 while on medications) pregnant or breastfeeding women

Number of arms
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

Gordon Saxe

Inclusion age min
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : April 13, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

54

primary outcome
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

Adverse Events;Alanine transaminase;Aspartate transaminase;Creatinine;Partial Thromboplastin Time;Prothrombin time

Notes
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 1/Phase 2

Arms
Last imported at : Dec. 16, 2020, 10:02 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 526, "treatment_name": "Fotv", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]