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    Summary
    EudraCT Number:2020-002120-37
    Sponsor's Protocol Code Number:RESP301-002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-06-08
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2020-002120-37
    A.3Full title of the trial
    An open-label, adaptive randomized, controlled multicenter study to evaluate the efficacy and safety of RESP301 plus standard of care (SOC) compared to SOC alone in hospitalized participants with COVID-19 requiring supplemental oxygen (NOCoV2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, adaptive randomized, controlled multicenter study to evaluate the efficacy and safety of RESP301+SOC vs SOC in hospitalized participants with COVID-19 requiring supplemental oxygen
    A.4.1Sponsor's protocol code numberRESP301-002
    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 SponsorThirty Respiratory Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThirty Respiratory Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThirty Respiratory Limited
    B.5.2Functional name of contact pointClinical department
    B.5.3 Address:
    B.5.3.1Street Address1 Red Place
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1K 6PL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)1235 431 201
    B.5.6E-mailcontact@30.technology
    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 No
    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 nameRESP301
    D.3.2Product code RESP301
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Nitrite
    D.3.9.1CAS number 7632-00-0
    D.3.9.3Other descriptive nameSODIUM NITRITE
    D.3.9.4EV Substance CodeSUB15308MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62.10
    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 Yes
    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
    Coronavirus disease 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease 2019 (COVID-19)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10061986
    E.1.2Term SARS
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate efficacy of RESP301 in preventing progression of hospitalized COVID-19 participants at level 4 in the modified World Health Organization (WHO) ordinal scale into levels >4.
    E.2.2Secondary objectives of the trial
    • To assess the effect of RESP301 as measured by room air SpO2.
    • To assess the effect of RESP301 as measured by the National Early Warning Score (NEWS) 2 symptom score.
    • To assess the treatment response on clinical status.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant is ≥18 years of age, at the time of signing the informed consent.
    2. Participant has laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcriptase polymerase chain reaction (RT-PCR) or other approved clinical testing prior to randomization.
    3. Participant is hospitalized in relation to COVID-19, requiring supplemental oxygen to maintain SpO2 at a safe level (WHO level 4).
    4. Participant is male or female. All females of childbearing potential, including pregnant females, must consent to urine pregnancy testing at screening to be eligible for the study.
    (Females who are not of childbearing potential do not need to undergo a pregnancy test at screening).
    5. Participant is capable of giving signed informed consent as described in the protocol.
    E.4Principal exclusion criteria
    1. Rapidly deteriorating or likely to require escalation to high flow oxygen, invasive or non-invasive ventilatory support within 24 hours according to Investigator’s opinion.
    2. Unable to safely receive a nebulized treatment for approximately 4 minutes according to Investigator’s opinion.
    3. Unable to receive or considered ineligible for invasive or non-invasive ventilatory support.
    4. History of methemoglobinemia.
    5. Uncontrolled asthma or history of severe bronchospasm.
    6. Severe (requiring baseline oxygen therapy > 12 h/day prehospitalization) chronic respiratory disease (e.g., known COPD, pulmonary arterial hypertension, idiopathic pulmonary fibrosis, interstitial lung disease).
    7. Suspected or confirmed untreated, active tuberculosis.
    8. Severely immune-compromised participants in Investigator’s opinion.
    9. Recent (within 3 months) active coronary artery disease or decompensated heart failure (New York Heart Association class 3-4).
    10. Presence of tracheostomy.
    11. Chronic (≥4 weeks) use of corticosteroids >10 mg/day of prednisone or equivalent within 4 weeks of randomization.
    12. Participation in other clinical investigations utilizing investigational treatment or within 30 days / 5 half-lives whichever is longer.
    13. Clinically significant abnormalities in clinical chemistry or hematology at screening, defined as:
    • Platelet count <50,000 mm3.
    • Alanine aminotransferase or aspartate aminotransferase >5 × upper limit of normal (ULN).
    • Estimated glomerular filtration rate <30 mL/min/1.73 m2(modification of diet in renal disease formula) or requiring hemofiltration or dialysis.
    14. Anticipated transfer to another hospital which is not a study site during the treatment period.
    15. Allergy to any of the components of the study intervention.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of participants who progress to level >4 of modified WHO ordinal scale due to COVID-19 by Day 14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    By Day 14.
    E.5.2Secondary end point(s)
    • Change in room air SpO2 from baseline over time.
    • Change in NEWS 2 symptom score from baseline over time.
    • Change from baseline on the modified WHO ordinal scale at each visit up to Day 28.
    • Time to improvement to a lower level (<4) of modified WHO ordinal scale.
    • Time to progression to a higher level (>4) of modified WHO ordinal scale.
    • Time to hospital discharge.
    • Incidence of mortality by Day 28.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to Day 28.
    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) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care (SOC) alone, i.e. SOC without concomitant RESP301
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    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 (last subject day 28 EoS follow-up visit globally).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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: 195
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 2020-06-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 300
    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)
    After the end of the study, participants may continue their Standard of care (SOC) (if any). Study intervention for COVID-19 will not continue beyond this study.
    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 Decision2020-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-27
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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