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 oxyge

Phase 1

• Conditions: Coronavirus disease 2019 (COVID-19); MedDRA version: 20.0Level: LLTClassification code 10061986Term: SARSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-002120-37-GB
• Lead Sponsor: Thirty Respiratory Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-08
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified