Status:
COMPLETED
A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19
Lead Sponsor:
Thirty Respiratory Limited
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The effect of RESP301 as an add on treatment to SOC will be evaluated for its efficacy in reducing rate of progression to a more severe level of COVID-19 and for safety, by comparison with SOC alone i...
Detailed Description
This is an open-label, randomized, multicenter, parallel group, concurrent, controlled study using a sequential adaptive design to evaluate the efficacy and safety of RESP301 plus SOC versus SOC alone...
Eligibility Criteria
Inclusion
- 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.
- Participant is hospitalized in relation to COVID-19, requiring supplemental oxygen to maintain SpO2 at a safe level (WHO level 3 \& 4).
- Participant is capable of giving signed informed consent
- 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.
Exclusion
- 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.
- Unable to safely receive a nebulized treatment for approximately 8 minutes according to Investigator's opinion.
- Unable to receive or considered ineligible for invasive or non-invasive ventilatory support.
- History of methemoglobinemia.
- Presence of uncontrolled asthma, history of severe bronchospasm.
- Presence of severe chronic respiratory disease and tracheostomy.
- Suspected or confirmed untreated, active tuberculosis.
- Severely immune-compromised participants in Investigator's opinion.
- Recent active coronary artery disease or decompensated heart failure.
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04460183
Start Date
July 29 2020
End Date
May 21 2021
Last Update
June 2 2022
Active Locations (2)
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1
Imperial College Healthcare NHS Trust, St. Mary's Hospital
London, United Kingdom, W2 1NY
2
Royal Preston Hospital
Preston, United Kingdom, PR2 9HT