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

Chulalongkorn University

Status: Unknown

Conditions: Infection Viral

Treatments: Other: Placebo; Other: Longan nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT04887233

214/64

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Longan nasal spray

Experimental group

Description:

The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days.

Treatment:

Other: Longan nasal spray

Placebo nasal spray

Placebo Comparator group

Description:

The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days.

Treatment:

Other: Placebo