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Efficacy and Safety of Nasal Spray Solution Containing Human IgG1 Anti-COVID-19 Antibody Cocktail

NCT05358873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-07-07

No results posted yet for this study

Summary

Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail is a medical device innovated to provide the dual-action physical barrier on nasal mucosa that aids the natural defence in which the mucus layer is fortified by a steric barrier-forming agent HPMC and invading viral particles of all major SARS-CoV-2 VOCs, including Delta and Omicron, are locally trapped and blocked from entering the cells by the highly-specific human IgG1 anti-SARS-CoV-2 monoclonal antibody cocktail.

Conditions

  • SARS CoV 2 Infection
  • SARS-CoV-2 Acute Respiratory Disease

Interventions

DEVICE

Human IgG1 anti-SARS-CoV-2 antibody cocktail

Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail

DEVICE

Placebo

Normal saline

Sponsors & Collaborators

  • Ramathibodi Hospital

    collaborator OTHER

  • Ever Medical Technology Co., Ltd.

    collaborator UNKNOWN

  • The Government Pharmaceutical Organization

    collaborator OTHER_GOV

  • Ministry of Health, Thailand

    collaborator OTHER_GOV

  • HIBIOCY CO., Ltd.

    collaborator UNKNOWN

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Thanarathi Imsuwansr, MD · National Cancer Institute, Thailand

  • Dhammika Leshan Wannigama, MD PhD · Chulalongkorn University

  • Thitinan Jongthitinon, MD · National Cancer Institute, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05358873 on ClinicalTrials.gov