COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04601077


Column Value
Trial registration number NCT04601077
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04601077

First author
Last imported at : Dec. 9, 2022, 4 a.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Dec. 9, 2022, 4 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-10-23

Recruitment status
Last imported at : Dec. 9, 2022, 4 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

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

inclusion criteria: male or female of 50-85 years of age subjects with recent covid-19 diagnosis (within 72 hours), that are symptomatic (fever, cough, sob, weakness, or other flu-like symptoms). agrees to comply with study procedures (diary, oximeter readings, telephone follow up). has given voluntary, written, informed consent to participate in the study. identifies as african american or hispanic origin patients must have at least 1 risk factor (history of hypertension (bp> 140/99) chf, angina, prior mi, coronary angiography with one significantly occluded vessel, diabetes mellitus, obesity, or smoking, (for at least 5 years).

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

females who are pregnant, breastfeeding or planning to become pregnant during the course of the study. patients unresponsive or unable to take anything by mouth (npo). individuals who are cognitively impaired and/or who are unable to give informed consent. blood pressure below 110 mmhg systolic and 60 mmhg diastolic on entry into study. history of syncope or other symptoms of orthostatic hypotension. history of methemoglobinemia. severe case of g6pd deficiency

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Nitric Oxide Innovations LLC

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

50

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

85

Countries
Last imported at : Dec. 11, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Dec. 9, 2022, 4 a.m.
Source : ClinicalTrials.gov

524

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

dizziness;Low blood pressure

Notes
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 891, "treatment_name": "Nitric oxide lozenges", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]