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    Summary
    EudraCT Number:2020-001656-18
    Sponsor's Protocol Code Number:INOCOV-19
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNorway - NOMA
    A.2EudraCT number2020-001656-18
    A.3Full title of the trial
    Inhaled Nitric Oxide As A Bridge To Mechanical Ventilation In Patients With Suspected Covid-19 Respiratory Failure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The aim of this trial is to see how we can increase the amount of oxygen in the blood of a patient who may suffer from Covid-19 and severe breathing difficulties. Such patient often need intubation and mechanical ventilation, and we will compare twi ways of preparing for such intubation. The first is todays normal treatment with the patient breathing 100% oxygen on a bag/mask with some resistance. The other is that oxygen treatment combined with inhaled nitric oxide.
    A.3.2Name or abbreviated title of the trial where available
    INOCOV-19
    A.4.1Sponsor's protocol code numberINOCOV-19
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1250-1698
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOslo University Hospital
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOslo University Hospital
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointAir Ambulance Department
    B.5.3 Address:
    B.5.3.1Street AddressKirkeveien 166
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0450
    B.5.3.4CountryNorway
    B.5.4Telephone number4722 11 80 80
    B.5.6E-mailcbuskop@ous-hf.no
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name INOmax 800 ppm mol/mol
    D.2.1.1.2Name of the Marketing Authorisation holderLinde Healthcare AB
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameINOmax
    D.3.4Pharmaceutical form Medicinal gas, compressed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe respiratory failure in patients with confirmed, suspected or probable Covid- 19 disease
    E.1.1.1Medical condition in easily understood language
    Patients that are, or may be, infected with the new corona virus and have difficulties breathing.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objective of the study is to evaluate the clinical efficacy and safety of INO compared to standard treatment prior to and during emergency RSI in hypoxic patients with suspected or confirmed COVID-19
    E.2.2Secondary objectives of the trial
    *Evaluate the safety of the intervention as compared to the control as assed by: Circulatory function, Kidney function , Hemoglobin function, Platelet count
    *Evaluate the clinical efficacy of INO compared to standard treatment on respiratory severity and length of specialized care
    *Evaluate the effect of INO on cardiac stress
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All criteria must apply

    Patients ≥ 18 years of age at the time of inclusion

    and

    who are confirmed, suspected or probable cases of covid-19 based on WHO definitions

    and

    SpO2 <90% after 3 minutes 10 cm H2O PEEP + 100% O2

    and

    who are treated by a physician who have specifically undergone formal training in pre-hospital INO administration and the present protocol.
    E.4Principal exclusion criteria
    Only one criterion needs to apply for exclusion:
    1. Patients who after 3 mins of ventilation with 10 cm H2O PEEP + 100% O2 i.e. at time of allocation (t0), have a SpO2 <50%, or a reliable SpO2 is impossible to obtain
    2. Patients in severe kidney failure or dialysis,
    3. Known or suspected pregnancy based on information on the time of inclusion.
    4. Hypersensitivity to the active substance (NO) or to the excipient (N2)
    5. Cardiac arrest
    6. Patient in prison or custody by police
    7. Staff present in treatment situation known to be pregnant
    8. Any reason why, in the opinion of the treating physician, it is probably in the best interest of the patient not to participate in the trial.


    Female participants under the age of 50 years will be asked explicitly about possible pregnancy. If this cannot be obtained from the patient, next of kin will be asked if present. Information regarding exclusion criteria 2, 3 and 4 will be obtained from bystanders, often relatives or friends present at time of inclusion. If no clear information is available, the physicians shall include or exclude based on his/her best judgment at the time of inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the change in SpO2, and the null hypothesis is that there is no difference in the change in SpO2 following initiation of INO
    E.5.1.1Timepoint(s) of evaluation of this end point
    five minutes after the allocation of treatment arm, with IMP being administered by bag/mask ventilation, with 100% oxygen at a flow of 10lite/minute and a Positive End Expiratory pressure of 10 centimeter water.
    E.5.2Secondary end point(s)
    SpO2 during Rapid Sequence Intubation (tRSI)

    SpO2 from t1 to End of intervention

    Number of patients with SpO2<50 from t1 to End of intervention

    Respiratory rate from t0 to tRSI or End of intervention

    PaO2 at t0 to End of intervention

    Cardiac arrest during intervention

    GOS-E score on day 28

    Mortality

    Secondary

    Heart rate at t0-tn

    Blood pressure at t0 to tn

    Increase in Serum urea concentration

    KDIGO AKI Stage up to day 28

    Arterial MetHgb concentration

    Platelet count

    Need for INO after End of intervention
    E.5.2.1Timepoint(s) of evaluation of this end point
    At specified time point between allocation and end of intervention, which is when inhaled nitric oxide on INOBlender is stopped. Secondary end points also evaluated at day 28 after allocation
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The inclusion criteria in this study is hypoxia to an extent representing a severe medical condition. Therefore, at the time of inclusion, the patient is neither competent to consent, nor able to receive any information about the study.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state54
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No changes to normal treatment for condition
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-19
    P. End of Trial
    P.End of Trial StatusOngoing
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