COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002120-37/GB

Thirty Respiratory Limited - Clinical department

contact@30.technology

2020-06-08

Recruiting

RCT

Randomized

Adaptive

Open label

multi-center

Treatment

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.

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.

2

Thirty Respiratory Limited

18

100

United Kingdom;United States

Moderate disease at enrollment

3: Moderate disease at enrollment

60

• Proportion of participants who progress to level >4 of modified WHO ordinal scale due to COVID-19 by Day 14.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "", "treatment_id": 1217, "treatment_name": "Sodium nitrite", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}]