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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04887233
Other study ID # 214/64
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date June 30, 2022

Study information

Verified date May 2021
Source Chulalongkorn University
Contact Pornanong Aramwit, Ph.D
Phone +66899217255
Email aramwit@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 30, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Age 18-60 years - Positive nasal swab test of coronavirus disease 2019 (COVID-19) (reverse transcriptase-polymerase chain reaction (RT-PCR) ??????? (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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chulalongkorn University

Outcome

Type Measure Description Time frame Safety issue
Primary Nasal swab test negative There will be a negative reverse transcriptase-polymerase chain reaction (RT-PCR) test 3 days
Secondary Absent of respiratory symptoms There will be a body temperature less than 37.5 degree celsius and absent of respiratory symptoms. 3 days
Secondary No adverse event There will be no allergic reaction 3 days
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