Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects

NCT06063330 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: RQ-01-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 6

Brief Summary

This is a first in human clinical study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of RQ-01. Adult patients who have tested positive for SARS-CoV-2 virus, have mild symptom(s) of COVID-19 disease, and who are at low risk for developing moderate or severe COVID-19 disease are welcome to participate. The main questions this study aims to answer are:

1. 1.What is the safety profile of RQ-01?
2. 2.What is the reduction in SARS-CoV-2 ribonucleic acid (RNA) shedding after administration of RQ-01?
3. 3.How effective is RQ-01 versus placebo in reducing COVID-19 symptoms?

Conditions

COVID-19; Infectious Disease; Symptomatic COVID-19 Infection Laboratory-Confirmed; SARS CoV 2 Infection

Keywords

First in Human; Phase 1; COVID; Telemedicine

Outcome Measures

Primary Outcomes (4)

• Incidence of TEAEs

  The difference between treatment arms in the incidence of treatment-emergent adverse events (TEAEs) leading to withdrawal of study drug or study discontinuation through Day 33/End of Study.

  Through 33 days

• Change in clinical laboratory results

  The difference between treatment arms in the change from baseline in clinical laboratory results.

  Through 33 days

• Change in physical examination results

  The difference between treatment arms in the change from baseline in physical examination results.

  Up to 33 days

• Change in vital signs

  The difference between treatment arms in the change from baseline in vital signs.

  Up to 33 days

Secondary Outcomes (9)

• Change in SARS-CoV-2 RNA shedding

  Through 33 days

• Proportion of subjects with undetectable SARS-CoV-2 RNA shedding

  Up to 33 days

• Change in SARS-CoV-2 RNA shedding

  Up to 5 days

• Proportion of subjects with negative RT-qPCR

  Through 33 days

• Time to negative RT-qPCR

  Up to 33 days

Study Arms (3)

Low Dose of RQ-01

EXPERIMENTAL

Subjects in this arm will receive 5 mg per day (for 3 days) of RQ-01

Combination Product: RQ-001

High Dose of RQ-01

EXPERIMENTAL

Subjects in this arm will receive 10 mg per day (for 3 days) of RQ-01

Combination Product: RQ-001

Placebo

PLACEBO COMPARATOR

Subjects in this arm will receive 0 mg per day (for 3 days) of RQ-01

Other: Placebo

Interventions

RQ-001 COMBINATION_PRODUCT

Drug product RQ-001 is the fully assembled device consisting of the vial containing RQ-01 and the actuator. Drug Product RQ-001 has been developed with an Aptar Bidose liquid nasal spray unit device (BDSI V3) capable of intranasally delivering a 200 uL total volume of drug product (specifically, 100 uL per nare, which delivers a 200 uL of total volume). The combination product comprises the drug constituent (RQ-01) and the assembly of commercially available, off-the-shelf device components. Study staff will be responsible for assembling the drug product RQ-001 and subjects will self-administer under the supervision of study staff in the clinic.

High Dose of RQ-01; Low Dose of RQ-01

Placebo OTHER

Matching placebo will be manufactured just as RQ-01 drug substance, with the active ingredient addition step omitted. Placebo will appear similar to RQ-01 drug substance as a clear to hazy, colorless to yellowish liquid. Matching placebo will be administered the same way as RQ-01

Placebo

Eligibility Criteria

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

You may qualify if:

• Age 18-64, inclusive, at the time of consent.
• Have mild COVID-19 disease symptom(s) at screening and at randomization, as defined in the protocol.
• Female subjects must have a negative urine pregnancy test at screening.
• Females of childbearing potential must agree to abstain from heterosexual intercourse or use highly effective contraception, as defined in the protocol.
• Male subjects must agree to abstain from heterosexual intercourse or use double barrier protection with condom and spermicide with any sexual partner who has the capacity for pregnancy and agree to not donate sperm.
• Understand the risks of the trial and consents to study conduct documented by signing of the study informed consent form.
• Willing and able to comply with this protocol and be available for the entire duration of the study.

You may not qualify if:

• Moderate or severe COVID-19 disease at the time of screening, including but not limited to displaying one or more of the following clinical symptoms outlined in the protocol
• Individuals who are eligible for FDA authorized or approved COVID-19 therapeutics (e.g., antivirals or monoclonal antibodies)
• Subjects at high-risk for COVID-19 disease severity progression at the time of screening, defined as subjects with known history or current diagnoses of any of the following conditions outlined in the protocol.
• Sinusitis ongoing for more than 4 weeks at the time of screening.
• Clinically significant epistaxis, as determined by the Investigator, within 3 months prior to screening.
• Nasal or sinus surgery within 12 weeks prior to screening, planned to occur during the study, or a history of any nasal or sinus surgery that in the opinion of the Investigator may influence COVID-19 disease symptoms or spray administration of the study drug.
• Nasal polyps or other non-infectious condition that could cause nasal obstruction, such as severe nasal septal deviation.
• Use of intranasal, inhaled, or oral corticosteroid medications of any kind within 14 days prior to the first dose of study drug, or planned use during the study that may affect the administration and/or absorption of study drug. Note: The use of oral antihistamines is permitted during the study.
• Use of antivirals or monoclonal antibodies for the management of COVID-19 disease or other viruses (e.g., influenza) within 60 days prior to the first dose of study drug.
• Received a vaccination for COVID-19 disease (original series or boosters) within 30 days prior to the first dose of study drug, and/or has plans to receive a COVID-19 vaccination (original series or boosters) during the trial through Day 33. Note: Other vaccinations are permitted during the trial through Day 33 and must be reported as a concomitant treatment.
• Have known systemic hypersensitivity to the RQ-01 drug substance, its inactive ingredients, or the ingredients of the matching placebo.
• For female subjects, are pregnant or breastfeeding, are \< 1 month post-partum or are planning to become pregnant during the study.
• Have any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of the subject's safety or study results.
• Unwilling to abstain from participating in another interventional clinical study with an investigational compound or device, including SARS-CoV-2 therapeutics.

Sponsors & Collaborators

• Red Queen Therapeutics, Inc.: lead
• PPD Development, LP: collaborator

Study Sites (6)

LA Universal Research Center, Inc.

Los Angeles, California, 90057, United States

Location

Florida International Medical Research

Miami, Florida, 33134, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Vilo Research Group, L.L.C.

Houston, Texas, 77017, United States

Location

Evergreen Hospital Medical Center

Kirkland, Washington, 98034, United States

Location

Related Links

• Study Website

MeSH Terms

Conditions

COVID-19; Communicable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Eisenberg, MD, MPH

  Red Queen Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There are 3 different treatment arms that subjects will be randomized in a 1:1:1 ratio. The arms will be evenly distributed with 22 subjects in each arm: 1) low dose of RQ-01; 2) high dose of RQ-01; 3) Placebo

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: October 2, 2023
• Study Start: September 27, 2023
• Primary Completion: January 3, 2024
• Study Completion: January 3, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)