COVID-19Phase 1NCT06063330
Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects
A Phase 1 study testing RQ-001 in people with COVID-19 and Infectious Disease, run by Red Queen Therapeutics, Inc. at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- COVID-19, Infectious Disease, Symptomatic COVID-19 Infection Laboratory-Confirmed
- What is being tested?
- RQ-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Sep 2023to 3 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Zenos Clinical Research
Dallas, Texas, 75230
Vilo Research Group, L.L.C.
Houston, Texas, 77017
Evergreen Hospital Medical Center
Kirkland, Washington, 98034
LA Universal Research Center, Inc.
Los Angeles, California, 90057
Florida International Medical Research
Miami, Florida, 33134
About this study
Official title: A Phase 1, Multicenter, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects
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:
- What is the safety profile of RQ-01?
- What is the reduction in SARS-CoV-2 ribonucleic acid (RNA) shedding after administration of RQ-01?
- 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.
Read the detailed description
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.
- Conditions
- COVID-19, Infectious Disease, Symptomatic COVID-19 Infection Laboratory-Confirmed, SARS CoV 2 Infection
- Being tested
- RQ-001, Placebo
- Keywords
- First in Human, Phase 1, COVID, Telemedicine
- Medical subject headings
- COVID-19, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RQ-001Combination 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.
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| Low Dose of RQ-01 | Experimental | Subjects in this arm will receive 5 mg per day (for 3 days) of RQ-01 Receives: 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 Receives: Combination Product: RQ-001 |
| Placebo | Placebo comparator | Subjects in this arm will receive 0 mg per day (for 3 days) of RQ-01 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through 33 days
Change in clinical laboratory results
The difference between treatment arms in the change from baseline in clinical laboratory results.
Measured: Through 33 days
Change in physical examination results
The difference between treatment arms in the change from baseline in physical examination results.
Measured: Up to 33 days
Change in vital signs
The difference between treatment arms in the change from baseline in vital signs.
Measured: Up to 33 days
Secondary outcomes (9)
Change in SARS-CoV-2 RNA shedding
The difference between treatment arms in the time-weighted average change in log10 SARS-CoV-2 SARS-CoV-2 RNA shedding from Baseline (Day 1) through Day 33 as measured by RT-qPCR.
Measured: Through 33 days
Proportion of subjects with undetectable SARS-CoV-2 RNA shedding
The difference between treatment arms in the proportion of subjects with undetectable SARS-CoV-2 RNA shedding as measured by RT-qPCR by visit.
Measured: Up to 33 days
Change in SARS-CoV-2 RNA shedding
The difference in the change from baseline to Day 5 between treatment arms in the AUC SARS-CoV-2 RNA shedding as measured by RT-qPCR.
Measured: Up to 5 days
Proportion of subjects with negative RT-qPCR
The difference between treatment arms in the proportion of subjects with negative RT-qPCR through Day 33.
Measured: Through 33 days
Time to negative RT-qPCR
The difference between treatment arms in the time to negative RT-qPCR.
Measured: Up to 33 days
Proportion of rebounds
The difference between treatment arms in the proportion of rebounds (defined as: viral RNA ≥lower limit of quantitation (LLOQ) after Day 5 if <LLOQ at Day 5, or ≥1 log10 increase in viral RNA copy number (relative to Day 5) after Day 5 if ≥LLOQ at Day 5.
Measured: Through 33 days
Proportion of subjects using additional therapeutic alternatives
The difference in proportion between treatment arms of subjects who used additional therapeutic alternatives for the management COVID-19 disease (as recommended by the National Institutes of Health [NIH]) for non-hospitalized COVID-19 subjects by treatment arms through Day 33.
Measured: Through 33 days
Proportion of subjects with no symptoms
The difference in proportion between treatment arms of subjects with no symptoms through Day 33 as measured by the 15 items COVID-19 Symptoms Score.
Measured: Through 33 days
Mean change in symptoms
The difference in the mean change from baseline through Day 33 as measured by the 15 items COVID-19 Symptoms Score.
Measured: Through 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start27 Sep 2023
- Primary completion3 Jan 2024
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Red Queen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Paul Eisenberg, MD, MPH, Study director, Red Queen Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063330
- Sponsor's protocol ID
- RQ-01-001
- Status last verified
- Jan 2024
- First submitted
- 17 Sep 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects
- ClinicalTrials.gov ID
- NCT06063330
- Acronym / sponsor ID
- RQ-01-001
- Conditions
- COVID-19, Infectious Disease, Symptomatic COVID-19 Infection Laboratory-Confirmed, SARS CoV 2 Infection
- Keywords
- First in Human, Phase 1, COVID, Telemedicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Red Queen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the safety profile of RQ-01?
- What is the reduction in SARS-CoV-2 ribonucleic acid (RNA) shedding after administration of RQ-01?
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Low Dose of RQ-01 | Experimental | Combination Product: RQ-001Subjects in this arm will receive 5 mg per day (for 3 days) of RQ-01 |
| High Dose of RQ-01 | Experimental | Combination Product: RQ-001Subjects in this arm will receive 10 mg per day (for 3 days) of RQ-01 |
| Placebo | Placebo comparator | Other: PlaceboSubjects in this arm will receive 0 mg per day (for 3 days) of RQ-01 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RQ-001Drug 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. | Combination product | High Dose of RQ-01, Low Dose of RQ-01 |
| PlaceboMatching 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 | Other | Placebo |
Primary outcome
Incidence of TEAEs
Time frame: Through 33 days
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.
Change in clinical laboratory results
Time frame: Through 33 days
The difference between treatment arms in the change from baseline in clinical laboratory results.
Change in physical examination results
Time frame: Up to 33 days
The difference between treatment arms in the change from baseline in physical examination results.
Change in vital signs
Time frame: Up to 33 days
The difference between treatment arms in the change from baseline in vital signs.
9 secondary outcomes
Change in SARS-CoV-2 RNA shedding
Time frame: Through 33 days
Proportion of subjects with undetectable SARS-CoV-2 RNA shedding
Time frame: Up to 33 days
Change in SARS-CoV-2 RNA shedding
Time frame: Up to 5 days
Proportion of subjects with negative RT-qPCR
Time frame: Through 33 days
Time to negative RT-qPCR
Time frame: Up to 33 days
Proportion of rebounds
Time frame: Through 33 days
Proportion of subjects using additional therapeutic alternatives
Time frame: Through 33 days
Proportion of subjects with no symptoms
Time frame: Through 33 days
Mean change in symptoms
Time frame: Through 33 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Eisenberg, MD, MPH study director
Red Queen Therapeutics
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RQ-001 in people with COVID-19 and Infectious Disease, run by Red Queen Therapeutics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs (time frame: Through 33 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.