Clinical Efficacy of Nitric Oxide Nasal Spray (NONS) for the Treatment of Mild COVID-19 Infection - NONS for COVID-19 Treatment

Ashford and St Peter's Hospitals NHS Foundation Trust0 个研究点目标入组 50 人开始时间: 2020年10月21日最近更新: 2021年1月5日

适应症

试验速览

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•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;
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

•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).

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