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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-06-30

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.

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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.

Conditions

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Infection Viral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Longan nasal spray

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

Group Type EXPERIMENTAL

Longan nasal spray

Intervention Type OTHER

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

Placebo nasal spray

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Longan nasal spray

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

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

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