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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

Find a Location

Who is running the clinical trial?

PPDIndustry Sponsor
159 Previous Clinical Trials
36,849 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be a participant in this experimental research?

"This coronavirus trial is open to individuals aged 18-64 that have been diagnosed with the virus. The study needs 66 participants in total."

Answered by AI

To what degree is the Low Dose of RQ-01 detrimental to human health?

"The safety of Low Dose of RQ-01, based on Power's evaluation scale from 1 to 3, is believed to be a low risk due its Phase I status. This suggests that there is limited data in regards to both efficacy and safety."

Answered by AI

Is this investigation accepting participants who are aged 65 and above?

"As listed in the trial's inclusion criteria, all participants must be between 18 and 64 years old. On clinicialtrials.gov there are 292 trials for patients under 18 and a further 1,207 clinical studies targeting those older than 65."

Answered by AI

Is this research endeavor in need of additional participants?

"Affirmative. According to the research hosted on clinicaltrials.gov, this investigation is currently recruiting participants. It was initially posted on September 27th 2023 and last modified a day later. The study requires 66 individuals at 9 distinct sites for completion."

Answered by AI

How many locations within the state are currently conducting this research?

"Participants in this trial can be recruited from LA Universal Research Center, Inc. (Los Angeles, California), AGA Clinical Trials - Hypercore - PPDS (Hialeah, Florida) and Miami's Florida International Medical Research as well as nine other sites."

Answered by AI

Could you provide the total cap of subjects enrolled in this experiment?

"Sixty-six volunteers that abide by the prerequisites of this research can partake in it at LA Universal Research Center, Inc. or AGA Clinical Trials - Hypercore - PPDS (both located in California and Florida respectively)."

Answered by AI

What goals are researchers attempting to achieve through this clinical experiment?

"This trial, which will last for 33 days, is primarily evaluating the changes in clinical laboratory results. Secondary outcomes to be assessed include differences in SARS-CoV-2 RNA shedding levels measured by RT-qPCR., variations between treatment arms of subjects with negative RT-qPCR results and duration until a patient tests negative on an RT-qPCR test."

Answered by AI

Who else is applying?

What site did they apply to?
Cullman Clinical Trials
Zenos Clinical Research
Vilo Research Group, L.L.C.
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Hoping to find something that helps.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Vilo Research Group, L.L.C.: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects
2023. "Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06063330.
All > Paid Studies Seattle
~42 spots leftby Apr 2025
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