Most patients have mild to moderate degree infection in which the virus is confined within the nasal cavity and upper respiratory tract, a place where the infection begins. If this group of patients can be treated rapidly and successfully, it can reduce severity and mortality and decrease the spreading to others. This can maintain the balance and stability of the health care system on limited resources. nitric oxide nasal spray, hypromellose, mild Covid-19 infection
Conditions
Interventions
The experiment group was given self-administered nitric oxide nasal spray (NONS). Contains approximately 100-140 microliters of nitric oxide solution per bottle of 25 ml. The participant must spray in
Experimental Device,Placebo Comparator Device
nitric oxide nasal spray plus hypromellose,Placebo nasal spray
Sponsors
Fresh Body Co., Th.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.COVID infection was confirmed with a laboratory PCR nasal swab or antigen test within the 48 hours before screenings, 2. Mild COVID infection, 3.Asymptomatic participants, 4. Female patients had a history of sterilization surgery or under menopause (no menstruation for at least 12 months), 5.Male patients had a history of vasectomy or use a condom based method of contraception and do not donate sperm, 6.Capable of understanding and providing signed informed consent before participating in this protocol, 7.Ability to adhere to the internet, internet connection devices, and telehealth checkups to follow up and assess outcomes of this protocol, 8.Participants with acute illness or hospitalized 30 days before study enrollment are eligible to join this study, based on the opinion of the investigator
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other types of respiratory infections (non-COVID-19). 2. Patients with a current tracheostomy or laryngectomy. 3. Patients who are receiving concomitant respiratory therapy such as oxygen, positive airway pressure, or ventilator support. 4. Patients who use nasal steroids such as fluticasone, budesonide, mometasone, and/or triamcinolone. 5. Patients who need hospitalization for reasons other than COVID-19 infection. 6. Patients who are unable to self-administer the nasal spray as prescribed. 7. Females who are breastfeeding, pregnant, or planning or attempting to become pregnant. 8. Patients diagnosed with COVID-19 for more than 3 days before randomization. 9. Patients who are mentally or neurologically disabled, and severe anxiety. 10. Patients who have any severe respiratory disease such as lung disease, traumatic thoracic injury, had a history of lung surgery, had liver or kidney disease therapy, or who are receiving concomitant liver or kidney disease therapy. 11. Patients with an allergic reaction to Hypromellose and/or nitric oxide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical recovery at 1-4, 5 and 8 day after end of the intervention WHO Progression Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of recovery measured before treatment begun on Day1) to Day 2, Day 3, and Day 4 and The time (days) to clinical recovery for 80% or more of the participants WHO Progression Scale Score ,COVID-19 symptoms at 1-4, 5 and 8 day after end of the intervention COVID-19 symptoms questionnaire,Clinical Status at 1-4, 5 and 8 day after end of the intervention Clinical Status Ordinal Scale ,Viral load and Viral Variation Day 1 and 8 day after end of the intervention qRT-PCR viral,Quality of Life Day 1 and 8 day after end of the intervention Quality of Life Questionnaire,Stress & anxiety score Day 1 and 8 day after end of the intervention Stress & anxiety test,AEs at 1-4, 5 and 8 day after end of the intervention Adverse Event Assessment,Hospitalization and death at 1-4, 5 and 8 day after end of the intervention COVID 19 Hospitalization (CHS) Form | — |
Countries
Thailand
Contacts
Public ContactJarinratn Sirirattawan
Department of Otolaryngology, Faculty of Medicine
Outcome results
None listed