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NCT06063330
Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects
Phase 1 trial testing RQ-001 in COVID-19 in 66 participants. Completed in 3 January 2024.
3 January 2024
Quick facts
| Lead sponsor | Red Queen Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 66 |
| Start date | 27 September 2023 |
| Primary completion | 3 January 2024 |
| Estimated completion | 3 January 2024 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- RQ-001
- Placebo
Conditions studied
- COVID-19 — all drugs for COVID-19 →
- Infectious Disease — all drugs for Infectious Disease →
- Symptomatic COVID-19 Infection Laboratory-Confirmed — all drugs for Symptomatic COVID-19 Infection Laboratory-Confirmed →
- SARS CoV 2 Infection — all drugs for SARS CoV 2 Infection →
Sponsor
Red Queen Therapeutics, Inc.
Who can join
Adults 18 to 64, any sex, with COVID-19 or Infectious Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06063330
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06063330 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Red Queen Therapeutics, Inc.
- Last refreshed: 11 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06063330.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing