E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COVID-19 infection caused by SARS-CoV-2 |
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E.1.1.1 | Medical condition in easily understood language |
COVID-19 is an infection caused by the virus SARS-CoV-2. Some of the patients develop a severe acute respiratory syndrome and need mechanical ventilation. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038700 |
E.1.2 | Term | Respiratory infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to measure the difference in ventilator treatment time between the iNO and the control group. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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. 2. Time to reach normoxia for at least 24 hours, defined by a PaO2/FiO2> 300 mmHg 3. Proportion of normoxemic patients in the two groups during the first 28 days after enrollment. 4. Hemodynamic changes as measured by echocardiography at day 4 (pulmonary pressure etc). 5. Survival at 28 days and 90 days from enrollment.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. PaO2/FiO2 ratio 2. Hours an minutes 3. 28 days after enrollment 4. After 4 days 5. 28 days and 90 days after enrollment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
No addition to standard of care |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |