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

Sponsor

Chulalongkorn University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04887233

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection Viral	Other: Longan nasal spray Other: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Longan nasal spray The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days.	Other: Longan nasal spray The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days.
Placebo Comparator: Placebo nasal spray The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days.	Other: Placebo The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days.

Arm

Intervention/Treatment

Experimental: Longan nasal spray

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

Other: Longan nasal spray

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

Placebo Comparator: Placebo nasal spray

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

Other: Placebo

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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