NOCoV2 [COVID-19]
Research type
Research Study
Full title
NOCoV2 - 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 requiring supplemental oxygen
IRAS ID
284062
Contact name
Katherine Murtagh
Contact email
Sponsor organisation
30 Respiratory
Eudract number
2020-002120-37
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Coronavirus disease 2019 (COVID-19) is a highly contagious respiratory illness which has become a global pandemic. Most people who contract the disease will have mild symptoms, but some will get a more severe form of the infection and require hospitalisation.\n30 Technology have developed a novel treatment, RESP301, that in laboratory tests has been shown to be very effectively knock out multiple strains of COVID-19 and the proposed clinical study is designed to help those patients needing hospital care and supplemental oxygen to support their breathing.\nAll participants in the study will receive the best standard of care that is available in the hospital. In addition, two out of every three participants will receive the study drug, RESP301. This will be given three times a day for up to 10 days via a hand-held nebuliser, very similar to the inhaler used by many people with asthma. All participants will know whether they are receiving RESP301 or not.\nThe aim of this study is to assess the safety and effectiveness of the study drug RESP301 plus standard treatment as compared to standard treatment alone. It is hoped that treatment with RESP301 could slow the rate of progression to severe disease and possibly speed up the rate of recovery. RESP301 has never been used in humans before so the outcome is not known, hence the need for a clinical trial. However, all the ingredient in RESP301 have been used extensively before and shown to be safe as inhaled medicines. The active ingredient is amolecule, nitric oxide, which is produced normally in the lungs as a defence against virus infection. RESP301 releases the molecule in the lungs close to where the virus is located and the aim is to attack the virus and supplement the body’s own defence. The study will recruit participants currently suffering from mild to moderate COVID-19 whom require additional oxygen as part of their standard treatment. Participants will be in the study for up to 30 days, including screening, treatment and follow-up.\nThe company sponsoring this research study is Thirty Respiratory, part of the 30Technology Group. This study will be run in the United Kingdom, United States and other European countries and will aim to recruit approximately 300 adult participants.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0171
Date of REC Opinion
27 May 2020
REC opinion
Further Information Favourable Opinion