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 forSARS-CoV-2 virus, have mild symptom(s) of COVID-19 disease, and who are at low risk fordeveloping moderate or severe COVID-19 disease are welcome to participate. The mainquestions 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 thetrial, subjects will participate in the following activities: perform rapid antigen andpolymerase chain reaction (PCR) tests for COVID-19, answer questions about their medicalhistory and medications, answer questions about their COVID-19 history and symptoms,conduct a physical exam, have their vitals measured, and have bloodwork done.
This is a first in human study to evaluate the safety, PK, and PD of RQ-01 when
administered to adult subjects 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. Subjects will be exposed to RQ-01 after nasal administration with the
Aptar Bidose nasal spray device (BDSI V3). The decrease in SARS-CoV-2 RNA shedding will
be measured by reverse transcription-quantitative polymerase chain reaction (RT- qPCR)
compared with placebo. There are currently no Food and Drug Administration (FDA) approved
therapies for subjects with mild symptoms of COVID who are low risk for progression to
moderate-severe disease. Safety of the subjects in this study is supported by the safety
margin for local adverse events, lack of systemic exposure, and availability of antiviral
therapies for COVID-19 should subjects' disease progress.
The study may be conducted using traditional outpatient clinic sites or a hybrid model,
using clinic sites and/or virtual sites, with provisions made to conduct aspects of the
study via telehealth and/or within subjects' homes. The hybrid model will provide the
flexibility required to offer the trial in areas with increased incidence of COVID-19
disease, to maximize access to trial participation, and to increase diversity of trial
subjects.
Potential study subjects will be identified for screening based on having at least one
mild symptom consistent with COVID-19 disease. Potential study subjects may additionally
present with a positive SARS-CoV-2 rapid antigen test (RAT), taken either at-home, or
administered at a facility (e.g., urgent care testing site). As detailed within the
inclusion criteria, different entry requirements apply depending on the source and timing
of the positive rapid antigen test. For all subjects, the time from first positive
SARS-CoV-2 rapid antigen test result to time of first dose must not exceed 3 days. Also,
the first dose of study drug must be administered within 4 days of the estimated initial
onset of symptoms of COVID-19 disease.
Subjects who provide written informed consent and meet all eligibility criteria will be
randomized in a 1:1:1 manner to RQ-01 (high or low dose) or placebo. On the day of
randomization, all subjects must have at least one mild symptom of COVID-19 disease and a
positive SARS-CoV-2 RAT result. After the first six subjects are enrolled (2 in each
group) and have completed all study procedures through Day 7 an early interim safety
analysis will be performed by the Data Monitoring Committee. Enrollment of new subjects
will continue only after review by the Data Monitoring Committee and the decision to
proceed communicated to the investigators.
Prior to the first dose of study drug, all subjects must be trained by study staff on
study drug self-administration with the Aptar Bidose nasal spray device, per the
instructions provided within the Pharmacy Manual and/or subject-facing materials.
Subjects will self-administer all doses of study drug while observed in-person by the
Investigator or designee, who must be a trained healthcare professional. Subjects will
then be followed for an additional 30 days for overall safety including COVID-19 disease
symptoms.
If at any point during the study a subject meets the treatment discontinuation criteria
outlined within the protocol, including a worsening of COVID-19 disease symptoms, the
subject will be immediately discontinued from study drug and will continue in follow-up
as described within the protocol.
Combination Product: RQ-001
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.
Other: Placebo
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
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.
LA Universal Research Center, Inc.
Los Angeles 5368361, California 5332921, United States
Florida International Medical Research
Miami 4164138, Florida 4155751, United States
University of Maryland School of Medicine
Baltimore 4347778, Maryland 4361885, United States
Zenos Clinical Research
Dallas 4684888, Texas 4736286, United States
Vilo Research Group, L.L.C.
Houston 4699066, Texas 4736286, United States
Evergreen Hospital Medical Center
Kirkland 5799841, Washington 5815135, United States
Paul Eisenberg, MD, MPH, Study Director
Red Queen Therapeutics