Inhaled Nitric Oxide Gas Therapy in Mechanically Ventilated Patients with Severe Acute Respiratory Syndrome in COVID-19 - NOSARSCOVID19

Massachussetts General Hospital0 sites200 target enrollmentApril 3, 2020

ConditionsARDS caused by COVID-19 infection Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ARDS caused by COVID-19 infection
Sponsor: Massachussetts General Hospital
Enrollment: 200
Status: Active, Not Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 3, 2020

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Massachussetts General Hospital

Eligibility Criteria

Inclusion Criteria

•1\. Adult patients, \> 18 year\-old
•2\. Patients admitted to the ICU
•3\. Patients who are intubated and mechanically ventilated;
•4\. Confirmed diagnosis of SARS\-CoV2 by positive rt\-PCR;
•5\. Severe hypoxemia, defined by PaO2/FiO2 \< 300 mmHg.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 100
•F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

•1\. Patients intubated for more than 72 hours from initiation of the treatment gas
•2\. 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

Outcomes

Primary Outcomes

Not specified

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