Infection Viral
Conditions
Keywords
Longan, nasal spray, COVID 19, efficacy, safety
Brief summary
The objectives of this study are to evaluate efficacy and safety of longan extract spray (P80 spray) in volunteers with coronavirus disease 2019 (COVID19).Patients who infected COVID 19 (positive COVID 19 RT-PCR from nasal swab) are enrolled in the study. They will be treated with standard treatment of COVID 19. In addition, the patients will received longan extract nasal spray (P80 spray) or placebo nasal spray for 3 days (6 times). After that, they will be nasal swabbed for detecting COVID 19 infection. Adverse event will also be evaluated by physician or nurse.
Detailed description
Patients who infected COVID 19 (positive COVID 19 RT-PCR from nasal swab) and pass inclusion criteria are enrolled in the study. The patients will be checked the clinical symptoms and chest x-ray by physician. They will be treated with standard treatment of COVID 19. In addition, the patients will received longan extract nasal spray (P80 spray) or placebo nasal spray for 3 days (6 times). Physician or nurse will ask for adverse events every day. After 3 days, the patients will be nasal swabbed for detecting COVID 19 infection.
Interventions
OTHERLongan nasal spray
The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days.
OTHERPlacebo
The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-60 years * Positive nasal swab test of coronavirus disease 2019 (COVID-19) (reverse transcriptase-polymerase chain reaction (RT-PCR) เป็นบวก (cycle threshold \<40)) * Mild symptom with normal chest radiograph * No history of Chronic Obstructive Pulmonary Disease (COPD) and other chronic lung diseases, Chronic kidney disease (CKD), Cardiovascular diseases and congenital heart diseases, Cerebrovascular diseases, Poorly controlled diabetes,BMI \> 35 kg/m2, Cirrhosis, Immunocompromised condition * Can read and write * Vulnerable to participate
Exclusion criteria
* Allergic history to longan * Uncontrollable disease status * Pregnancy or lactation * Participated in other studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal swab test negative | 3 days | There will be a negative reverse transcriptase-polymerase chain reaction (RT-PCR) test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absent of respiratory symptoms | 3 days | There will be a body temperature less than 37.5 degree celsius and absent of respiratory symptoms. |
| No adverse event | 3 days | There will be no allergic reaction |
Contacts
Primary ContactPornanong Aramwit, Ph.D
Outcome results
None listed