COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004994-27/GB

Ashford and St Peter's Hospitals NHS Foundation Trust - Ms Freda Gomes

Freda.Gomes@nhs.net

2020-10-21

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol, Men and Women 18 years to 70 years of age, Internet access and capability and willingness to use to participate in audio or audio/video engagements with medical professionals, receive texts, emails, and phone calls from study staff and have a device and reasonable cellular data or other internet access to submit daily study required information using a smart phone, tablet, laptop, or desktop computer during the study period, COVID-19 infection confirmed with a laboratory SARS-CoV-2 RT-PCR nasal swab, Specimen collected within the past 48 hours, Mild COVID/FLU symptoms which may include no symptoms, fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath or dyspnea,

Not fit to consent and unable to follow the protocol , Men and Women Age >70 years, Current tracheostomy or laryngectomy, Concomitant respiratory therapy such as oxygen or ventilator support. Positive airway pressure for obstructive sleep apnea is permitted if treatment was established with good compliance at least 3 months before enrolment, Need for hospitalization for any reason, Inability to safely self-administer nasal spray Any clinical contraindications, as judged by the Qualified Medical Practitioner, Clinical signs indicative of moderate, severe or critical COVID severity symptoms (as defined by FDA COVID-19 Guidance Document) Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study, Lactating, pregnant or planning to become pregnant during the study period, Diagnosed with prior COVID-19 infection (>48 hours from the time the test is reported prior to the time of screening).

2

Ashford and St Peter's Hospitals NHS Foundation Trust

18

70

United Kingdom

Mild disease at enrollment

1: Mild disease at enrollment

50

Difference in SARS-CoV-2 viral load (Cycle threshold) from baseline through Day 6 between NONS and control arms.

nan

Phase 2

[{"arm_notes": "", "treatment_id": 892, "treatment_name": "Nitric oxide releasing solution", "treatment_type": "Other anti-infectives", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]