Coronavirus disease 2019 (COVID-19) MedDRA version: 20.0 Level: LLT Classification code 10061986 Term: SARS System Organ Class: 100000004862
Conditions
Interventions
Product Name: RESP301
Product Code: RESP301
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Sodium Nitrite
CAS Number: 7632-00-0
Other descriptive name: SODIUM NITRITE
Concentration unit:
Sponsors
Thirty Respiratory Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 195 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 105
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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.;Secondary Objective: • 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.;Primary end point(s): • Proportion of participants who progress to level >4 of modified WHO ordinal scale due to COVID-19 by Day 14.;Timepoint(s) of evaluation of this end point: By Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 hospital discharge. • Incidence of mortality by Day 28.;Timepoint(s) of evaluation of this end point: Up to Day 28. | — |
Countries
France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactClinical department
Thirty Respiratory Limited
Outcome results
None listed