Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects
COVID-19, Infectious Disease, Symptomatic COVID-19 Infection Laboratory-Confirmed
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring First in Human, Phase 1, COVID, Telemedicine
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- LA Universal Research Center, Inc.
- AGA Clinical Trials - Hypercore - PPDS
- Florida International Medical ResearchRecruiting
- University of Maryland School of Medicine
- Prime Global Research, Inc.
- Zenos Clinical ResearchRecruiting
- Vilo Research Group, L.L.C.
- Zion Urgent Care Clinic
- Evergreen Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Low Dose of RQ-01
High Dose of RQ-01
Placebo
Subjects in this arm will receive 5 mg per day (for 3 days) of RQ-01
Subjects in this arm will receive 10 mg per day (for 3 days) of RQ-01
Subjects in this arm will receive 0 mg per day (for 3 days) of RQ-01