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

NCT04887233 | Unknown

• 1 other identifier: 214/64
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infection Viral

Keywords

Longan; nasal spray; COVID 19; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Nasal swab test negative

  There will be a negative reverse transcriptase-polymerase chain reaction (RT-PCR) test

  3 days

Secondary Outcomes (2)

• Absent of respiratory symptoms

  3 days

• No adverse event

  3 days

Study Arms (2)

Longan nasal spray

EXPERIMENTAL

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

Other: Longan nasal spray

Placebo nasal spray

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Longan nasal spray OTHER

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

Longan nasal spray

Placebo OTHER

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

Placebo nasal spray

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Allergic history to longan
• Uncontrollable disease status
• Pregnancy or lactation
• Participated in other studies

Sponsors & Collaborators

• Chulalongkorn University: lead

MeSH Terms

Conditions

Virus Diseases; COVID-19

Condition Hierarchy (Ancestors)

Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pornanong Aramwit, Ph.D

  Chulalongkorn University

  STUDY DIRECTOR

Central Study Contacts

Pornanong Aramwit, Ph.D

CONTACT

+66899217255; aramwit@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 14, 2021
• Study Start: July 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share