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Trial - NCT04828668


Column Value
Trial registration number NCT04828668
Full text link
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04828668

First author
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

Thomas P Young, PhD, NP

Contact
Last imported at : Nov. 17, 2021, 7 p.m.
Source : ClinicalTrials.gov

tpy@n2ymedical.com

Registration date
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-04-02

Recruitment status
Last imported at : Sept. 23, 2022, 4 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Crossover

Masking
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Long covid

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

inclusion criteria: age 18 years of age or older who can provide informed consent. persons who have been diagnosed with covid-19 and now in post-acute recovery phase. persons who are in care with access to primary care for post covid infection or pacs. ability to read and write in the english language and follow study-related procedures. ability to have mail/ study drug delivered to an address and/or p.o. box in the recipient's name. ability to participate in telemedicine visits/communication. if a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal).

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

active illicit or non-prescribed drug use. concomitant use of benzodiazepines. concomitant use of an immune suppressant agent, e.g., prednisone. documented history and active treatment for seizure disorder. transaminase elevation. active autoimmune disorder. hepatitis c infection (currently on therapy and/or any transaminitis elevation). hepatitis b infection (currently on therapy and/or any transaminitis elevation). human immune deficiency virus (hiv-1 or hiv-2) infection that is newly diagnosed or untreated. any form of mental impairment that will/could hinder safe participation in the study. pregnancy or breast-feeding. any condition that in the opinion of the investigator would be harmful or detrimental to the participant.

Number of arms
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Endourage, LLC

Inclusion age min
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

75

Countries
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Sept. 23, 2022, 4 a.m.
Source : ClinicalTrials.gov

32

primary outcome
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC);Reduction in patient reported outcomes measures on the Patient Reported Outcomes Measurement Information System (PROMIS ®) assessment tools.

Notes
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Not reported

Arms
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": " ", "treatment_id": 567, "treatment_name": "Hemp seed oil", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": " ", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]