Efficacy and Safety of Longan Extract Spray (P80 Spray) in Volunteers With Coronavirus Disease 2019 (COVID-19)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Longan Extract Spray (P80 Spray) in Volunteers With Coronavirus Disease 2019 (COVID-19)

Conditions
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Infection Viral

Intervention / Treatment
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* Other: Longan nasal spray
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Longan nasal spray<br>The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days. | Other: Longan nasal spray<br>* The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days.<br>|
| Placebo Comparator: Placebo nasal spray<br>The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days. | Other: Placebo<br>* The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal swab test negative | There will be a negative reverse transcriptase-polymerase chain reaction (RT-PCR) test | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absent of respiratory symptoms | There will be a body temperature less than 37.5 degree celsius and absent of respiratory symptoms. | 3 days | 
| No adverse event | There will be no allergic reaction | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Longan, nasal spray, COVID 19, efficacy, safety