A Nasal Treatment for COVID-19 (COVD-TX)

August 23, 2023 updated by: James F. Chmiel, Indiana University

A Novel Nasal Treatment for COVID-19

The goal of this study is to test an investigational new inhaled medication called Optate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to test an investigational new inhaled medication called Optate. Investigational means it has not been approved by the Food and Drug Administration (FDA) for this use. The investigators hypothesize that Optate will reduce the length of symptoms and disease severity in patients with COVID-19 (Coronavirus disease of 2019) through inhibition of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) viral replication within the upper and lower airways. Testing this hypothesis is important because treatments for COVID-19 are needed alongside vaccines. COVID-19 begins in the nasal passages, so targeted therapies to the nasal passages at early stages of the disease may prevent severe disease from occurring.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Subjects, 18 and above, with mild COVID-19 upper respiratory tract infection symptoms

  • positive rapid COVID-19 test
  • Ordinal Scale for Clinical Improvement < 3 (OSCI, Appendix 2) and/or
  • Fever > 100 degree F and/or
  • Nasal congestion

Exclusion Criteria:

  • FEV1 (Forced Exhaled Volume) < 55% predicted on the day of study procedures
  • OSCI ≥ 3 (Objective Structured Clinical Exam)
  • Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
subjects on Treatment arm will get study drug
Drug: Optate
Alkaline Buffer
Other Names:
  • Glycine
Placebo Comparator: Placebo
subjects on Treatment arm will get placebo
Drug: Placebo
Normal Saline
Other Names:
  • Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Clinical Respiratory Viral panels and SARS-CoV-2 Levels
Time Frame: 6 months after enrollment opens
Clinical respiratory viral panels and SARS-CoV-2 levels will be measured in nasal wash before and one hour after Optate or placebo administration
6 months after enrollment opens

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey assessment
Time Frame: 6 months after enrollment closes
3.1.2 SNOT-22 scores (a validated, 22-item quality of life instrument survey) will be assessed immediately prior to Optate or placebo administration. Scores will be reassessed one hour after administration and 24 hours after administration.
6 months after enrollment closes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2023

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15989

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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