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Clinical Trials/EUCTR2020-001490-68-SE
EUCTR2020-001490-68-SE
Active, not recruiting
Phase 1

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

Stockholm County Council; Danderyd Hospital0 sites40 target enrollmentApril 1, 2020
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ConditionsCOVID-19 infection caused by SARS-CoV-2MedDRA version: 20.0Level: LLTClassification code 10038700Term: Respiratory infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsINOmax 800 ppm mol/mol, inhalation gas

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
COVID-19 infection caused by SARS-CoV-2
Sponsor
Stockholm County Council; Danderyd Hospital
Enrollment
40
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 1, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Stockholm County Council; Danderyd Hospital

Eligibility Criteria

Inclusion Criteria

  • •1\. Adult patients, \= 18 year\-old
  • •2\. Patients who are intubated and mechanically ventilated
  • •3\. Confirmed diagnosis of SARS\-CoV2 by positive rt\-PCR
  • •4\. Severe hypoxemia, defined by PaO2/FiO2 \< 300 mmHg
  • •5\. Informed consent
  • •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 20
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •1\. Patients intubated for more than 72 hours
  • •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.
  • •3\. Pregnancy

Outcomes

Primary Outcomes

Not specified

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