About: Protocol of a randomized controlled trial testing inhaled Nitric Oxide in mechanically ventilated patients with severe acute respiratory syndrome in COVID-19 (SARS-CoV-2).

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About: Protocol of a randomized controlled trial testing inhaled Nitric Oxide in mechanically ventilated patients with severe acute respiratory syndrome in COVID-19 (SARS-CoV-2). Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Protocol of a randomized controlled trial testing inhaled Nitric Oxide in mechanically ventilated patients with severe acute respiratory syndrome in COVID-19 (SARS-CoV-2).
Creator	Bellavia3, Andrea Dong1, Hailong Fakhr4, Bijan Fenza4, Raffaele Gianni4, Stefano Grassi4, Luigi Lei1, Chong Pinciroli4, Riccardo Su1, Binxiao Vassena4, Emanuele
Source	MedRxiv; Medline; PMC
abstract	INTRODUCTION. Severe acute respiratory syndrome due to novel Coronavirus (SARS-CoV-2) related infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxemia. To date, there is no specific treatment available for COVID-19. Nitric oxide is a selective pulmonary vasodilator gas used as a rescue therapy in refractory hypoxemia due to acute respiratory distress syndrome (ARDS). In has also shown invitro and clinical evidence that inhaled nitric oxide gas (iNO) has antiviral activity against other strains of coronavirus. The primary aim of this study is to determine whether inhaled NO improves oxygenation in patients with hypoxic COVID-19. This is a multicenter randomized controlled trial with 1:1 individual allocation. Patients will be blinded to the treatment. METHODS AND ANALYSIS. Intubated patients admitted to the intensive care unit with confirmed SARS-CoV-2 infection and severe hypoxemia will be randomized to receive inhalation of NO (treatment group) or not (control group). Treatment will be stopped when patients are free from hypoxemia for more than 24 hours. The primary outcome evaluates levels of oxygenation between the two groups at 48 hours. Secondary outcomes include rate of survival rate at 28 and 90 days in the two groups, time to resolution of severe hypoxemia, time to achieve negativity of SARS-CoV-2 RT-PCR tests. ETHICS AND DISSEMINATION. The study protocol has been approved by the Investigational Review Board of Xijing Hospital (Xi’an, China) and by the Partners Human Research Committee (Boston, USA). Recruitment will start after approval of both IRBs and local IRBs at other enrolling centers. Results of this study will be published in scientific journals, presented at scientific meetings, reported through flyers and posters, and published on related website or media in combating against this widespread contagious disease. TRIAL REGISTRATION. Clinicaltrials.gov. NCT04306393
has issue date	2020-05-24(xsd:dateTime)
bibo:doi	10.1101/2020.03.09.20033530
bibo:pmid	32511534
has license	cc-by-nc-nd
sha1sum (hex)	2573dda9612d0e3fbd0a8aa620be93b61352812c
schema:url	https://doi.org/10.1101/2020.03.09.20033530
resource representing a document's title	Protocol of a randomized controlled trial testing inhaled Nitric Oxide in mechanically ventilated patients with severe acute respiratory syndrome in COVID-19 (SARS-CoV-2).
has PubMed Central identifier	PMC7273302
has PubMed identifier	32511534
schema:publication	medRxiv
resource representing a document's body	covid:2573dda9612d0e3fbd0a8aa620be93b61352812c#body_text
is schema:about of	named entity 'treatment group' named entity 'severe' named entity 'patients' named entity 'RT-PCR' named entity 'hypoxemia' named entity 'preprint' named entity 'Nitric Oxide' named entity 'randomized controlled trial' named entity 'patients' named entity 'SARS-COV-2 INFECTION' named entity 'TIME' named entity 'REFRACTORY' named entity 'DATE' named entity '2019-NCOV' named entity 'CLINICAL' named entity 'ACUTE RESPIRATORY DISTRESS SYNDROME' named entity 'PATIENTS' named entity 'acute respiratory distress syndrome (ARDS)' named entity 'strains' named entity 'study' named entity 'multicenter' named entity 'Patients' named entity '90 days' named entity 'SARS-CoV-2' named entity 'activity' named entity 'Treatment' named entity 'vasodilator' named entity 'SARS-CoV-2' named entity 'invitro' named entity 'infection' named entity 'hypoxemia' named entity 'medRxiv' named entity 'preprint' named entity 'survival rate' named entity 'control group' named entity 'SARS-CoV-2' named entity 'inhalation' named entity 'COVID-19' named entity 'Nitric Oxide' named entity 'nitric oxide' named entity 'clinical trial' named entity 'medRxiv' named entity 'Coronavirus' named entity 'ARDS' named entity 'COVID-19' named entity 'log-rank test' named entity 'oxygen' named entity 'organ dysfunction' named entity 'SARS-CoV' named entity 'DSMB' named entity 'written consent' named entity 'adverse events' named entity '28 days' named entity 'Mann-Whitney U test' named entity 'rt-PCR' named entity 'RT-PCR' named entity 'SARS-CoV2' named entity '28 days' named entity 'preprint' named entity '2019-nCoV' named entity 'SARS-CoV-2' named entity 'DSMB' named entity 'pathogen' named entity 'preprint' named entity 'log-rank test' named entity 'sample size' named entity 'vasopressors' named entity 'iNO' named entity 'multiorgan failure' named entity 'ICUs' named entity 'nitric oxide' named entity 'control patients'

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