Inhaled Nitric Oxide Gas Therapy in Respiratory Treated Patients with COVID-19 infectio
Phase 1
- Conditions
- Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]COVID-19 infection caused by SARS-CoV-2MedDRA version: 20.0Level: LLTClassification code 10038700Term: Respiratory infectionSystem Organ Class: 100000004862
- Registration Number
- EUCTR2020-001490-68-SE
- Lead Sponsor
- Stockholm County Council; Danderyd Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
F.1.3.1 Number of subjects for this age range 20
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to measure the difference in ventilator treatment time between the iNO and the control group.;Secondary Objective: The secondary objective is to assess whether patients in the iNO group, compared to the control group, experience an improvement in arterial oxygenation and survival up to 3 months after recruitment to the study.<br><br>;Primary end point(s): The primary endpoint is the difference in the duration of continuous ventilator treatment until successful extubation between the treatment and the control group. Successful extubation is defined as 24 hours out of mechanical ventilation.;Timepoint(s) of evaluation of this end point: Number of days and hours
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Difference in oxygenation between the treatment and the control group after 48 hours. Oxygenation will be measured in terms of PaO2/FiO2 ratio.<br>2. Time to reach normoxia for at least 24 hours, defined by a PaO2/FiO2> 300 mmHg<br>3. Proportion of normoxemic patients in the two groups during the first 28 days after enrollment. <br>4. Hemodynamic changes as measured by echocardiography at day 4 (pulmonary pressure etc).<br>5. Survival at 28 days and 90 days from enrollment.<br>;Timepoint(s) of evaluation of this end point: 1. PaO2/FiO2 ratio<br>2. Hours an minutes <br>3. 28 days after enrollment<br>4. After 4 days<br>5. 28 days and 90 days after enrollment