COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2

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Brief Title

COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2

Official Title

Community Participants With COPD or Bronchiectasis and at Risk of Respiratory Viral Infections Including SARS-CoV-2: An Open-label, Multicentre Feasibility Study of an Inhaled Nitric Oxide Generating Solution (RESP301)

Brief Summary

      Patients with a respiratory disease are at higher risk of poor outcomes due to worsening of
      symptoms caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and other
      respiratory infections. New therapies are needed for treating high risk patients at early
      stages of an infection. This study will assess the feasibility and safety of using an inhaled
      nitric oxide generating solution, RESP301, as a self-administered treatment following
      flare-up of symptoms.

      RESP301 is a liquid solution which produces nitric oxide in the lungs when inhaled using a
      nebuliser. The components of RESP301 are already used in clinical practice and inhaled nitric
      oxide is used as a treatment for newborns and patients with Chronic Obstructive Pulmonary
      Disease (COPD). In a laboratory setting, RESP301 has been shown to be effective against
      respiratory viruses, including SARS-CoV-2.

      This study aims to recruit approximately 150 adult patients with COPD or bronchiectasis in
      the United Kingdom (UK). A minimum of 70 participants will receive a test dose of RESP301
      during a screening visit. Response to the test dose will be monitored. Participants who
      tolerate the test dose will continue in the study and should contact the study team if they
      experience exacerbation symptoms in the next 52 weeks. Following a call with the site team to
      discuss symptoms, participants will receive RESP301 delivered to their home to
      self-administer for 7 days. The study duration for each participant will be at most 57 weeks,
      including the study visit and monthly calls. Participants who start the course of study
      treatment, will receive daily calls during the treatment period and will also be followed up
      after they complete the treatment.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Feasibility of self-administering RESP301 treatment in terms of commencing treatment

Secondary Outcome

 Tolerability of RESP301

Condition

COPD

Intervention

RESP301

Study Arms / Comparison Groups

 All participants
Description:  There is only one study arm. At least the first 70 eligible participants will receive a test dose of RESP301 at Screening Visit. Once test dose tolerability has been assessed in the first 70 participants, the Data Monitoring Committee will assess the safety data and it will be decided whether it will be required to administer test dose to assess tolerability in further patients. Participants who either (1) satisfactorily tolerate the test dose or (2) are not required to have a test dose, will be enrolled into the "dormant phase" of the study and advised to contact the study team as soon as practicable if they experience the following symptoms for at least 24 hours: fever, systemic malaise, and/or increased cough/wheeze and/or sputum volume/purulence. If the participant is suitable and willing to proceed to the treatment phase, they will receive a courier delivery of the study treatment to self-administer at home for 7 days (treatment phase).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

150

Start Date

April 2021

Completion Date

June 2022

Primary Completion Date

June 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Female of non-childbearing potential or male ≥35 years of age, at the time of signing
             the informed consent

          2. Able and willing to provide informed consent

          3. Spirometry-confirmed diagnosis of COPD (FEV1/FVC<0.7 post-bronchodilator) or
             computerised tomography (CT) proven bronchiectasis

        Exclusion Criteria:

          1. Unable to safely use a nebuliser as required by the study according to Investigator's
             opinion

          2. Severe COPD or bronchiectasis defined as FEV1 <20% or requiring non-invasive
             ventilation

          3. History of methaemoglobinaemia

          4. Baseline methaemoglobin concentration (using fingertip sensor) > 2%

          5. Uncontrolled or severe asthma or history of severe bronchospasm

          6. Presence of tracheostomy/inability to provide spirometry or contraindication for
             performing spirometry

          7. Anticipated transfer to another hospital/General practitioner (GP) practice which is
             not a study site during the treatment period

          8. Allergy to any of the components of the study intervention

          9. Participation in other clinical investigations utilising investigational treatment
             within the last 30 days / 5 half lives whichever is longer

         10. Deemed unlikely to be able to adhere to protocol in view of investigator

         11. Any subject who in the opinion of the investigator would not be best served by
             participating in this clinical trial

         12. Any unstable, uncontrolled or severe medical condition which in the opinion of the
             investigator would make the patient unsuitable for the trial

         13. Participant lives at home with no other adults in the household

         14. On long-term non-invasive ventilation and/or at higher risk of bronchospasm

         15. Prescribed Nitric Oxide donating agent (Nitroprusside, Isosorbide dinitrate,
             Isosorbide mononitrate, Naproxcinod, Molsidomine and Linsidomine)

         16. Female of childbearing potential

         17. Clinical diagnosis of COPD but Screening Visit spirometry at study centre excludes
             COPD (i.e. FEV1/FVC ratio is not <0.7)
      

Gender

All

Ages

35 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +44(0)1235431200, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT04858451

Organization ID

RESP301-005


Responsible Party

Sponsor

Study Sponsor

Thirty Respiratory Limited


Study Sponsor

, , 


Verification Date

April 2021