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A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19

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ClinicalTrials.gov Identifier: NCT04460183
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Thirty Respiratory Limited

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 in hospitalized COVID-19 patients.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: RESP301, a Nitric Oxide generating solution Other: Standard of Care Phase 2 Phase 3

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 in hospitalized patients with COVID-19 (World Health Organization [WHO] ordinal scale level 3 or 4).

Approximately 300 participants will be enrolled and randomized 2:1 to the Investigational arm or the Control arm. The study will be divided into the following periods: Screening period: (up to 2 days), Intervention (up to 10 days), follow-up (Day 14 and Day 28).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 WHO Grade 3&4 (NOCoV2)
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : January 27, 2021
Estimated Study Completion Date : April 23, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Investigational arm
Participants will receive inhaled RESP301 administered using a nebulizer three times a day for up to 10 days in addition to the standard of care.
Drug: RESP301, a Nitric Oxide generating solution
Product application requires inhalation using a standard handheld nebulizer.

Other: Standard of Care
Participants will receive institutional SOC for the treatment of COVID-19.

Active Comparator: Control arm
Participants will receive institutional SOC for the treatment of COVID-19
Other: Standard of Care
Participants will receive institutional SOC for the treatment of COVID-19.




Primary Outcome Measures :
  1. Proportion of participants who progress by at least one level higher on the modified WHO ordinal scale by Day 14 [ Time Frame: From Day 1 to Day 14 ]

Secondary Outcome Measures :
  1. Change in room air oxygen saturation (SpO2) from baseline over time [ Time Frame: Baseline to Day 28 ]
  2. Change in National Early Warning Score (NEWS) 2 symptom score from baseline over time [ Time Frame: Baseline to Day 28 ]
  3. Change from baseline on the modified WHO ordinal scale at each visit up to Day 28 [ Time Frame: Baseline to Day 28 ]
  4. Time to improvement of at least one level lower on the modified WHO ordinal scale [ Time Frame: Baseline to Day 28 ]
  5. Time to progression of at least one level higher on the modified WHO ordinal [ Time Frame: Baseline to Day 28 ]
  6. Number of participants with adverse events and serious adverse events [ Time Frame: Baseline to Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Participant is hospitalized in relation to COVID-19, requiring supplemental oxygen to maintain SpO2 at a safe level (WHO level 3 & 4).
  3. Participant is capable of giving signed informed consent
  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.

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 8 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. Presence of uncontrolled asthma, history of severe bronchospasm.
  6. Presence of severe chronic respiratory disease and tracheostomy.
  7. Suspected or confirmed untreated, active tuberculosis.
  8. Severely immune-compromised participants in Investigator's opinion.
  9. Recent active coronary artery disease or decompensated heart failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460183


Contacts
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Contact: Alison Bracchi, MSc +447763882519 alison.bracchi@30.technology

Locations
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United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust Recruiting
Bradford, United Kingdom, BD9 6RJ
Contact: Dinesh Saralaya    44 (0) 1274542200    Dinesh.Saralaya@bthft.nhs.uk   
Imperial College Healthcare NHS Trust, St. Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
Contact: Onn M Kon    44 (0)2078861344    onn.kon@nhs.net   
Pennine Acute Hospitals Trust (Nroth Manchester General Hospital) Recruiting
Manchester, United Kingdom, M8 5RB
Contact: Jennifer Hoyle       Jennifer.Hoyle@pat.nhs.uk   
Royal Preston Hospital Recruiting
Preston, United Kingdom, PR2 9HT
Contact: Mohammed Munavvar    44 (0) 1772 522416    mohammed.munavvar@lthtr.nhs.uk   
Sponsors and Collaborators
Thirty Respiratory Limited
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Responsible Party: Thirty Respiratory Limited
ClinicalTrials.gov Identifier: NCT04460183    
Other Study ID Numbers: RESP301-002
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents