COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04460183


Column Value
Trial registration number NCT04460183
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04460183

First author
Last imported at : Jan. 14, 2022, 10 a.m.
Source : ClinicalTrials.gov

Kate L McKeown, PhD

Contact
Last imported at : Jan. 14, 2022, 10 a.m.
Source : ClinicalTrials.gov

Kate.McKeown@30.technology

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

2020-07-07

Recruitment status
Last imported at : Jan. 14, 2022, 10 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

Open label

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

multi-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: participant has laboratory-confirmed sars-cov-2 infection as determined by reverse transcriptase polymerase chain reaction (rt-pcr) or other approved clinical testing prior to randomization. participant is hospitalized in relation to covid-19, requiring supplemental oxygen to maintain spo2 at a safe level (who level 3 & 4). participant is capable of giving signed informed consent participant is male or female. all females of childbearing potential, including pregnant females, must consent to urine pregnancy testing at screening to be eligible for the study.

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

rapidly deteriorating or likely to require escalation to high flow oxygen, invasive or non-invasive ventilatory support within 24 hours according to investigator's opinion. unable to safely receive a nebulized treatment for approximately 8 minutes according to investigator's opinion. unable to receive or considered ineligible for invasive or non-invasive ventilatory support. history of methemoglobinemia. presence of uncontrolled asthma, history of severe bronchospasm. presence of severe chronic respiratory disease and tracheostomy. suspected or confirmed untreated, active tuberculosis. severely immune-compromised participants in investigator's opinion. recent active coronary artery disease or decompensated heart failure.

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

Thirty Respiratory Limited

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

United Kingdom

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

Moderate disease at enrollment

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

3: Moderate disease at enrollment

Total sample size
Last imported at : Jan. 14, 2022, 10 a.m.
Source : ClinicalTrials.gov

19

primary outcome
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

Number of Participants Who Progress by at Least One Level Higher on the Modified WHO Ordinal Scale

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 2/Phase 3

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

[{"arm_notes": "", "treatment_id": 892, "treatment_name": "Nitric oxide releasing solution", "treatment_type": "Other anti-infectives", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]