COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20220510010

Jarinratn Sirirattawan

jeed9000@yahoo.co.th

2022-05-10

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

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

2

Fresh Body Co.; Th.

18

70

Thailand

Mild disease at enrollment

1: Mild disease at enrollment

500

Clinical recovery at 1-4; 5 and 8 day after end of the intervention WHO Progression Scale

Phase 3

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