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Trial - NCT04476992


Column Value
Trial registration number NCT04476992
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04476992

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

Nikolay O Kamenshchikov, M.D.

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

nikolajkamenof@mail.ru

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

2020-07-20

Recruitment status
Last imported at : April 30, 2022, 3:30 a.m.
Source : ClinicalTrials.gov

Completed

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: covid-19 confirmed by a positive rt-pcr test hospital admission within 11 days from the onset of symptoms spontaneous breathing with oxygen requirement ≥1 l/min expected discharge > 96 hours at randomization

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

pregnancy presence of a tracheostomy assistance by any non-invasive cpap or niv at the screening treatment with high flow nasal cannula at the screening clinical contraindication to the use of no patients enrolled in another interventional trial hospitalized and confirmed diagnosis of covid-19 for more than 7 days previous intubation for covid-19 subject not committed to full support (dnr, dni or cmo) subject requiring oxygen at home for lung comorbidities the primary cause of hospitalization not due to covid-19 subject receiving vasopressor at the time of screening history of malignancy or other irreversible disease/conditions with 6-month mortality >50% oxygen saturation of 100% at screening, despite oxygen requirement patients on dialysis at the time of enrollment

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

2

Funding
Last imported at : April 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Tomsk National Research Medical Center of the Russian Academy of Sciences

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

18

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

100

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

Russia

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

Mild/moderate disease at enrollment

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

2: Mild/moderate disease at enrollment

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

20

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

Change in Methemoglobin level at 48 hours

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": 890, "treatment_name": "Nitric oxide gas", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 890, "treatment_name": "Nitric oxide gas", "treatment_type": "Gas inhalation", "pharmacological_treatment": "Non pharmacological treatment"}]