Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19 (NOSARSCOVID)
Clara Health

Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19 (NOSARSCOVID)

Sponsored by Massachusetts General Hospital


No specifically targeted-treatment against the SARS-CoV-2 virus is available to-date. In separate randomized clinical studies, as a research group, we are currently focusing on inhaled nitric oxide gas (iNO), a pulmonary vasodilator which has shown antiviral activity against Coronavirus during the 2003 SARS outbreak.

However, in the current global health threat scenario, it might not be feasible to conduct appropriately designed interventional studies in every location. Observational data from a large dataset generated by a consortium of international institutions might help provide useful information and aid in the management of the crisis.

About 
COVID-19

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.

How is this study designed?

We designed a data collection strategy focusing on COVID-19 patients admitted to the ICU due to critical illness. Data can be entered in the registry both prospectively and retrospectively, provided a reliable source of clinical data is available within the center. The project has been approved by the Partners Institutional Review Board (Protocol #: 2020P000760).

The purpose of this study is to deploy a global, secure, user-friendly, adaptive, and reliable registry platform aimed at gathering insight into how critically ill patients due to COVID-19 are currently being treated worldwide.

Study Type: Interventional (Clinical Trial) Estimated Enrollment: 200 participants Primary Purpose: Treatment Actual Study Start Date: March 21, 2020 Estimated Study Completion Date: March 21, 2022

Who is this study for?

Inclusion criteria*:

  • Adult patients, >/= 18 year-old;
  • Patients admitted to the ICU;
  • Patients who are intubated and mechanically ventilated;
  • Confirmed diagnosis of SARS-CoV2 by positive rt-PCR.

Exclusion criteria*:

  • Patients intubated for more than 72 hours from initiation of the treatment gas;
  • Subjects enrolled in another interventional research study;
  • Physician of record opposed to enrolling the patient due to perceived safety concerns; or any condition that does not allow the protocol to be followed safely.

* Additional criteria apply. Please speak with the study team for further information.

What should I expect?

Thanks to a fast-paced turnover of data analysis and sharing we aim at providing the ICU community reliable information on important endpoints, such as:

  • A global snapshot of the population of patients admitted to the ICU due to COVID-19
  • The impact of pharmacologic therapies or rescue strategies being clinically implemented, like iNO or prone positioning
  • The assessment of risk factors and biomarkers to more precisely stratify the severity of disease
  • The impact of pharmacologic therapies currently being clinically used
  • Outcome prediction and survival analysis in order to provide useful information for the planning of the response by hospitals and healthcare systems
Inpatient trial

Have questions or need help?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.