Back to resultsEfficacy and Safety of Longan Extract Spray (P80 Spray) in Volunteers With Coronavirus Disease 2019 (COVID-19)
Primary Purpose
Infection Viral
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Longan nasal spray
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Infection Viral focused on measuring Longan, nasal spray, COVID 19, efficacy, safety
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Longan nasal spray
Placebo nasal spray
Arm Description
The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days.
The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days.
Outcomes
Primary Outcome Measures
Nasal swab test negative
There will be a negative reverse transcriptase-polymerase chain reaction (RT-PCR) test
Secondary Outcome Measures
Absent of respiratory symptoms
There will be a body temperature less than 37.5 degree celsius and absent of respiratory symptoms.
No adverse event
There will be no allergic reaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04887233
Brief Title
Efficacy and Safety of Longan Extract Spray (P80 Spray) in Volunteers With Coronavirus Disease 2019 (COVID-19)
Official Title
Efficacy and Safety of Longan Extract Spray (P80 Spray) in Volunteers With Coronavirus Disease 2019 (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection Viral
Keywords
Longan, nasal spray, COVID 19, efficacy, safety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Longan nasal spray
Arm Type
Experimental
Arm Description
The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days.
Arm Title
Placebo nasal spray
Arm Type
Placebo Comparator
Arm Description
The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days.
Intervention Type
Other
Intervention Name(s)
Longan nasal spray
Intervention Description
The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days.
Primary Outcome Measure Information:
Title
Nasal swab test negative
Description
There will be a negative reverse transcriptase-polymerase chain reaction (RT-PCR) test
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Absent of respiratory symptoms
Description
There will be a body temperature less than 37.5 degree celsius and absent of respiratory symptoms.
Time Frame
3 days
Title
No adverse event
Description
There will be no allergic reaction
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pornanong Aramwit, Ph.D
Phone
+66899217255
Email
aramwit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Ph.D
Organizational Affiliation
Chulalongkorn University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Longan Extract Spray (P80 Spray) in Volunteers With Coronavirus Disease 2019 (COVID-19)
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