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

Completed · Phase 1 · Has a placebo group

Conditions studied: COVID-19, Infectious Disease, Symptomatic COVID-19 Infection Laboratory-Confirmed, SARS CoV 2 Infection

In brief

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. What is the safety profile of RQ-01? 2. What is the reduction in SARS-CoV-2 ribonucleic acid (RNA) shedding after administration of RQ-01? 3. How effective is RQ-01 versus placebo in reducing COVID-19 symptoms? After providing informed consent, subjects will be randomized to RQ-01 (high or low dose) or placebo and will be dosed for 3 consecutive days. Throughout the duration of the trial, subjects will participate in the following activities: perform rapid antigen and polymerase chain reaction (PCR) tests for COVID-19, answer questions about their medical history and medications, answer questions about their COVID-19 history and symptoms, conduct a physical exam, have their vitals measured, and have bloodwork done.

Key facts

Study ID

NCT06063330

Run by

Red Queen Therapeutics, Inc.

People needed

66

Starts

2023-09-27

Expected to finish

2024-01-03

Last updated by the study team

2024-01-11

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• LA Universal Research Center, Inc. — Los Angeles, California, United States
• Florida International Medical Research — Miami, Florida, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Zenos Clinical Research — Dallas, Texas, United States
• Vilo Research Group, L.L.C. — Houston, Texas, United States
• Evergreen Hospital Medical Center — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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