CLINICAL TRIAL

GLS-1200 for Infections

Recruiting · 18+ · All Sexes · Baton Rouge, LA

This study is evaluating whether a nasal spray may help prevent the spread of a virus that causes SARS.

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About the trial for Infections

Eligible Conditions
Infections · Communicable Diseases · Coronavirus Disease 2019 (COVID‑19) · COVID-19 · Infection

Treatment Groups

This trial involves 2 different treatments. GLS-1200 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
GLS-1200
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 18 or older
Able and willing to comply with study procedures
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 4 weeks of treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 weeks of treatment.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether GLS-1200 will improve 2 primary outcomes and 1 secondary outcome in patients with Infections. Measurement will happen over the course of 4 weeks of treatment.

Symptom score of documented SARS-CoV-2 infection relative to treatment group with a higher score being a worse outcome.
4 WEEKS OF TREATMENT
Incidence of SARS-CoV-2 infection, confirmed by PCR relative to treatment group
4 WEEKS OF TREATMENT
Evaluate the number of GLS-1200 topical nasal spray adverse events as assessed by CTCAE v5.0
4 WEEKS OF TREATMENT

Patient Q & A Section

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

Who should consider clinical trials for infections?

Patients with a substantial risk of infection should be considered as potential participants in a drug trial for treatment or prophylaxis of infection. Furthermore, patients with a significant likelihood of infection should be considered candidates for a randomized controlled trial of treatments aimed at limiting morbidity or mortality of infection.

Anonymous Patient Answer

How many people get infections a year in the United States?

According to this model 1 infection will cause over 8 million admissions in the United States. Over 12 million people will be hospitalized during a year that includes an influenza epidemic. The data is from a 2002–2005 database for adults and excludes newborns.\n

Anonymous Patient Answer

What are the signs of infections?

Signs of infection include an erythematous, swollen, or tender lymph node, fever, lower-respiratory tract infection, or sepsis. Abnormal signs of infection may include an increased white blood count, pleural effusion, and pleural calcification on radiographic studies.

Anonymous Patient Answer

What is infections?

Infectious diseases are diseases caused by microbes. In an adult the most common infections are viral and bacterial (bacterial and helminthic). Pneumonia is a kind of infectious disease occurring when inhaled viruses are passed into the bloodstream.\n

Anonymous Patient Answer

Can infections be cured?

Infections are not curable, but may be managed by treating the underlying cause and eliminating the infection source. If infection is not manageable by other means, antibiotics may be beneficial in uncomplicated cases for uncomplicated infections, and antibiotics can reduce symptoms and the need for further testing and intervention.

Anonymous Patient Answer

What causes infections?

In common with infections by viruses and bacteria, the cause of many infections is unknown but infectious agents may act either positively or negatively on cells. The immune system may play a major role in some infections, while in others, the cause may be related to cellular damage. Viruses, bacteria, parasitic organisms and the body's immune response may also play a role. To date the most compelling evidence is of an ongoing global immune system response to certain pathogens causing infection. Some infections occur as part of a normal process of infection i.e. they are not a direct cause of disease. Examples are: the immune response to an infection-fighting antibody, or a type of immune response that generates a hypersensitivity reaction such as rheumatoid arthritis.

Anonymous Patient Answer

What are common treatments for infections?

The most common treatments for infections are medications, antibiotics being the most common. It is important that doctors and patients be informed about their treatment-seeking options, including alternatives to the use of medication or antibiotics, as well as the risks and benefits of these therapies.

Anonymous Patient Answer

What is the primary cause of infections?

Infections and malignancies are the most common cause of death. Infectious diseases account for about half of deaths, and malignancies account for two-thirds. [Mortality due to infections and malignancies are significantly higher than the national death rates (9.0% vs. 6.9% from all causes) (ABS 2007-08).] To find active infections and malignancy clinical trials in your area, you can use Power to search by condition, treatment, or location.

Anonymous Patient Answer

Have there been any new discoveries for treating infections?

Infections, though they continue to be the biggest cause of morbidity and mortality in our hospitals, have made very little headway over the past decade.

Anonymous Patient Answer

Does gls-1200 improve quality of life for those with infections?

Recent findings demonstrate that GL-1200 in addition to standard medical management can have a substantial impact on QOL for individuals with infections. Recent findings further demonstrate the importance of incorporating the patient's perspective, in addition to medical expert opinion, when designing and evaluating medical interventions.

Anonymous Patient Answer

Is gls-1200 safe for people?

Gls-1200 was generally well tolerated as a single-dose treatment in an ambulatory setting. It had a rapid onset, with a median time to peak levels of 0.5 hours. It was highly tolerable during all treatment periods, with no serious adverse events. Gls-1200 was safe and well tolerated even when administered as a single-dose treatment at a higher dose than this study was originally designed to evaluate. This trial-sequential decision-making paradigm is appropriate in the context of evaluating a drug regimen under an exploratory, proof-of-concept study design.

Anonymous Patient Answer

What are the common side effects of gls-1200?

As mentioned above, adverse drug reactions associated with the use of the new-generation gls-1200 treatment are similar to those seen previously for gls-100. It is likely that other products on the market will also have similar side effects.

Anonymous Patient Answer
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