Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects
Public ClinicalTrials.gov record NCT06063330. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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: 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 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.
Study identification
- NCT ID
- NCT06063330
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 66 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 27, 2023 (Actual)
- Primary completion
- Jan 3, 2024 (Actual)
- Completion
- Jan 3, 2024 (Actual)
- Last update posted
- Jan 11, 2024
2023 – 2024
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| LA Universal Research Center, Inc. | Los Angeles | California | 90057 | — |
| Florida International Medical Research | Miami | Florida | 33134 | — |
| 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 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06063330, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 11, 2024 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06063330 live on ClinicalTrials.gov.