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

Not Applicable

• Conditions: Infection Viral
• Interventions: Other: Placebo; Other: Longan nasal spray

• Registration Number: NCT04887233
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-14
• Last Update Submitted: 2021-05-14
• Last Update Posted: 2021-05-17
• Study Start: 2021-07-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo nasal spray	Placebo	The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days.
Longan nasal spray	Longan nasal spray	The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days.

Primary Outcome Measures

Name	Time	Method
Nasal swab test negative	3 days	There will be a negative reverse transcriptase-polymerase chain reaction (RT-PCR) test

Secondary Outcome Measures

Name	Time	Method
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