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

Indiana University

Status and phase: Enrolling; Phase 2

Conditions: COVID-19; Healthy

Treatments: Drug: Placebo; Drug: Optate

Study type: Interventional

Funder types: Other

Identifiers

NCT05799521

15989

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

COVID-19 PARTICIPANTS 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)
• Pregnancy
• Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication

HEALTHY CONTROLS Inclusion Criteria: Subjects, 18 and above, without mild COVID-19 upper respiratory tract infection symptoms

• negative rapid COVID-19 test
• No known medical problems or taking any medication that, in the investigator's opinion, would make them unsuitable for participation.

Exclusion Criteria:

• Pregnancy
• Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

Participants with COVID-19:Treatment

Experimental group

Description:

Participants with COVID-19:Treatment - subjects on this treatment arm will receive study drug

Treatment:

Drug: Optate

Participants with COVID-19: Placebo

Placebo Comparator group

Description:

Participants with COVID-19: Placebo - subjects on this arm will get placebo

Treatment:

Drug: Placebo

Healthy Controls: Treatment

Experimental group

Description:

Healthy Controls: Treatment - subjects on this treatment arm will receive study drug

Treatment:

Drug: Optate

Healthy Controls: Placebo

Placebo Comparator group

Description:

Healthy Controls: Placebo - subjects on this arm will get placebo

Treatment:

Drug: Placebo