Infection Viral Clinical Trial
Official title:
Efficacy and Safety of Longan Extract Spray (P80 Spray) in Volunteers With Coronavirus Disease 2019 (COVID-19)
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chulalongkorn University |
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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