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Virus Therapy

RQ-01 for COVID-19

Phase 1
Recruiting
Research Sponsored by Red Queen Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-64, inclusive, at the time of consent
Female subjects must have a negative urine pregnancy test at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 33 days
Awards & highlights

Study Summary

This trial is testing a potential COVID-19 treatment called RQ-01 in patients with mild symptoms. Subjects will answer questions, have their vitals measured, and have bloodwork done to assess safety, effectiveness, and how the body processes the drug.

Who is the study for?
Adults aged 18-64 with mild COVID-19 symptoms and low risk of severe disease can join. They must not be at high risk for disease progression, have had recent nasal surgery, or use certain steroids. Women must not be pregnant and agree to contraception; men must also agree to contraception.Check my eligibility
What is being tested?
The trial is testing RQ-01's safety and its effect on reducing the virus (SARS-CoV-2 RNA shedding) and COVID-19 symptoms compared to a placebo. Participants will receive either a high or low dose of RQ-01 or a placebo for three days.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions related to the body's response to new drugs such as allergies, gastrointestinal issues, headaches, or fatigue. Blood tests will monitor health throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 64 years old.
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I am a woman and my pregnancy test was negative.
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I agree to use effective birth control or abstain from sex.
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I am a man and agree to either not have sex or use double protection if my partner can get pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 33 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 33 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in clinical laboratory results
Change in physical examination results
Change in vital signs
+1 more
Secondary outcome measures
Change in SARS-CoV-2 RNA shedding
Mean change in symptoms
Proportion of rebounds
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose of RQ-01Experimental Treatment1 Intervention
Subjects in this arm will receive 5 mg per day (for 3 days) of RQ-01
Group II: High Dose of RQ-01Experimental Treatment1 Intervention
Subjects in this arm will receive 10 mg per day (for 3 days) of RQ-01
Group III: PlaceboPlacebo Group1 Intervention
Subjects in this arm will receive 0 mg per day (for 3 days) of RQ-01

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for COVID-19, particularly antiviral therapies, work by targeting various stages of the virus's life cycle to reduce viral load and alleviate symptoms. These treatments often inhibit viral replication, block viral entry into host cells, or enhance the immune response. For example, drugs like remdesivir inhibit the viral RNA polymerase, preventing the virus from replicating its genetic material. This is crucial for COVID-19 patients as it can reduce the severity and duration of symptoms, lower the risk of complications, and decrease the likelihood of virus transmission.
Conducting and critically appraising a high-quality systematic review and Meta-analysis pertaining to COVID-19.What to expect from different drugs used in the treatment of COVID-19: A study on applications and in vivo and in vitro results.Current status of COVID-19 treatment: An opinion review.

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Who is running the clinical trial?

PPDIndustry Sponsor
161 Previous Clinical Trials
36,923 Total Patients Enrolled
4 Trials studying COVID-19
230 Patients Enrolled for COVID-19
Red Queen Therapeutics, Inc.Lead Sponsor
Paul Eisenberg, MD, MPHStudy DirectorRed Queen Therapeutics
~40 spots leftby Jun 2025