Dyspnea Clinical Trial
— NoCovidOfficial title:
Nitric Oxide Gas Inhalation Therapy in Spontaneous Breathing Patients With Mild/Moderate COVID19 Infection: a Randomized Clinical Trial
Verified date | March 2020 |
Source | Xijing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (COVID-19) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on COVID-19 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 1, 2022 |
Est. primary completion date | March 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Laboratory confirmed COVID19 infection defined with a positive RT-PCR from any specimen. 2. Hospital admission with at least one of the following: - fever = 36.6 °C from axillary site; or = 37.2°C from oral site; or = 37.6°C from tympanic or rectal site. - Respiratory rate = 24 bpm - cough 3. Spontaneous breathing with or without hypoxia of any degree. Gas exchange and ventilation maybe assisted by any continuous continuous airway pressure (CPAP), or any system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) = 10 cmH2O. 4. = 8 days since onset of the symptoms Exclusion Criteria: 1. Pregnancy, or positive pregnancy test in a predose examination 2. Open tracheostomy 3. Therapy with high flow nasal cannula 4. Clinical controindication, as deemed by the attending physician |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Chen L, Liu P, Gao H, Sun B, Chao D, Wang F, Zhu Y, Hedenstierna G, Wang CG. Inhalation of nitric oxide in the treatment of severe acute respiratory syndrome: a rescue trial in Beijing. Clin Infect Dis. 2004 Nov 15;39(10):1531-5. Epub 2004 Oct 22. — View Citation
Keyaerts E, Vijgen L, Chen L, Maes P, Hedenstierna G, Van Ranst M. Inhibition of SARS-coronavirus infection in vitro by S-nitroso-N-acetylpenicillamine, a nitric oxide donor compound. Int J Infect Dis. 2004 Jul;8(4):223-6. — View Citation
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Feb 7. doi: 10.1001/jama.2020.1585. [Epub ahead of print] — View Citation
Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Feb 18. pii: S2213-2600(20)30076-X. doi: 10.1016/S2213-2600(20)30076-X. [Epub ahead of print] Erratum in: Lancet Respir Med. 2020 Feb 25;:. — View Citation
Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in the incidence of intubation and mechanical ventilation | The primary outcome will be the proportion of patients with mild COVID2019 who deteriorate to a severe form of the disease requiring intubation and mechanical ventilation. Patients with indication to intubation and mechanical ventilation but concomitant DNI (Do Not Intubate) or not intubated for any other reason external to the clinical judgment of the attending physician will be considered as meeting the criteria for the primary endpoint. | 28 days | |
Secondary | Mortality | Mortality from all causes | 28 days | |
Secondary | Negative conversion of COVID-19 RT-PCR from upper respiratory tract | Proportion of patients with a negative conversion of RT-PCR from an oropharyngeal or a nasopahryngeal swab | 7 days | |
Secondary | Time to clinical recovery | Time from initiation of the study to discharge or to normalization of fever (defined as <36.6°C from axillary site, or < 37.2°C from oral site or < 37.8°C from rectal or tympanic site), respiratory rate (< 24 bpm while breathing room air) and alleviation of cough (defined as mild or absent in a patient reported scale of severe >>moderate>>mild>>absent). | 28 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04688905 -
Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)
|
||
Completed |
NCT03679312 -
The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in COPD
|
Phase 1/Phase 2 | |
Recruiting |
NCT04868357 -
Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program
|
N/A | |
Active, not recruiting |
NCT03604822 -
Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS
|
N/A | |
Completed |
NCT03626519 -
Effects of Menthol on Dyspnoea in COPD Patients
|
N/A | |
Completed |
NCT02638649 -
Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
|
||
Completed |
NCT02538770 -
Rapid Viral Diagnostics in Adults to Reduce Antimicrobial Consumption and Duration of Hospitalization
|
N/A | |
Terminated |
NCT02269761 -
Chest Ultrasound of ER Patients With Cough or SOB
|
||
Completed |
NCT02248831 -
Evaluation of Cardiopulmonary Diseases by Ultrasound
|
N/A | |
Recruiting |
NCT01655199 -
Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease
|
N/A | |
Active, not recruiting |
NCT01440764 -
Aerosol Inhalation Treatment for Dyspnea
|
Phase 1/Phase 2 | |
Completed |
NCT01577407 -
Non Opioid Treatment for Experimental Dyspnea
|
Phase 3 | |
Completed |
NCT01193998 -
Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department
|
N/A | |
Recruiting |
NCT04327882 -
Point-of-care Ultrasound Interest in Dyspneic Emergency Department Patients: an Observational Bicentric Study
|
||
Completed |
NCT05029986 -
Preventing Dyspnea During Speech in Older Speakers
|
N/A | |
Not yet recruiting |
NCT04181359 -
The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in Interstitial Lung Disease.
|
Phase 1/Phase 2 | |
Recruiting |
NCT04615065 -
Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
|
||
Completed |
NCT04305639 -
The Reliability and Validity of Turkish Version of ''The Dyspnea-ALS-Scale (DALS-15)"
|
||
Completed |
NCT04370990 -
Automated Oxygen Administration -Rethinking Interventions Alleviating Dyspnea in Patients With COPD
|
N/A | |
Completed |
NCT04375917 -
Is Reduced Hypoxia Through a Robot Intervention, Associated With Sensory and Emotional Descriptions of Dyspnea, Anxiety, Depression, Symptom Burden and Anxiolytics
|
N/A |