What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common antiviral treatments for COVID-19, such as hydroxychloroquine (HCQ) and chloroquine (CQ), have been studied extensively. Known side effects of these treatments include gastrointestinal disturbances (nausea, vomiting, diarrhea), cardiovascular issues (QT prolongation, arrhythmias), and potential liver and kidney toxicity. Additionally, HCQ and CQ have not shown significant efficacy in reducing SARS-CoV-2 RNA shedding or alleviating COVID-19 symptoms in clinical trials. Other antiviral agents like remdesivir may cause side effects such as elevated liver enzymes, gastrointestinal symptoms, and potential allergic reactions.

What prior FDA approvals exist?

The FDA has approved remdesivir for the treatment of COVID-19 in both hospitalized and nonhospitalized patients. Remdesivir is an antiviral drug that inhibits RNA-dependent RNA polymerase, reducing SARS-CoV-2 RNA shedding and potentially shortening recovery time. It is administered intravenously and is dosed based on patient weight. This approval is based on data from randomized and observational studies in adults, which suggest that remdesivir may reduce the time to recovery, particularly in patients who are not critically ill.

What other types of research exist?

Promising alternatives to RQ-01 for COVID-19 treatment include remdesivir, which is FDA-approved and has shown antiviral activity, and immunomodulatory agents such as monoclonal antibodies targeting the spike protein of SARS-CoV-2. Additionally, drugs like nitazoxanide and teicoplanin have shown potential in vitro. It is important to consult with a healthcare provider to determine the most appropriate treatment based on the latest clinical evidence.

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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

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 33 days

Summary

This trial tests a new nasal spray treatment called RQ-01 for adults with mild COVID-19 symptoms. It aims to see if the spray can reduce the virus in the body and improve symptoms. The study focuses on people who are not likely to develop severe disease.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing severe symptoms of COVID-19.

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I am eligible for COVID-19 treatments like antivirals or antibodies.

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I have had sinusitis for more than 4 weeks.

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I have nasal polyps or a condition that blocks my nose.

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I haven't taken antivirals or monoclonal antibodies for COVID-19 or flu in the last 60 days.

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I am not participating in another clinical study with experimental treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 33 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in clinical laboratory results

Change in physical examination results

Change in vital signs

+1 more

Secondary study objectives

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

0 / 10Eligibility criteria met

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.