Is NCT05947955 recruiting in Augusta, GA?

Yes, NCT05947955 is currently recruiting participants at its Augusta, GA location. This acute respiratory distress syndrome clinical trial is actively enrolling qualified participants.

Is participation in this Augusta clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Respiratory Distress Syndrome Clinical Trial in Augusta, GA

Q: How do I join the acute respiratory distress syndrome clinical trial in Augusta?

To join this clinical trial in Augusta, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Acute Respiratory Distress Syndrome Study in Augusta

BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections. Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS.

Sponsor: BioAegis Therapeutics Inc.

Who Can Participate

Inclusion Criteria

Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist

Investigator or designee to note radiologic findings in the electronic case report form (eCRF)

Radiology report and conclusion should be summarized in the eCRF

A digital copy of the radiograph uploaded and saved for review

Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for ≤48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 ≤150). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L/min of 50% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP ≥5 cm H2O consistent with the original Berlin definition (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria.

Age ≥18 years

Informed consent obtained from subject/next of kin/legal proxy

Clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team

During the course of the study starting at screening and for at least 3 months after their final study treatment:

Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods

Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner

All subjects must agree not to donate sperm or eggs

Exclusion Criteria

Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, atelectasis, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings bas assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload.

Presence of systemic fungal, yeast, parasitic, or mycobacterial infection

Current or planned receipt of extracorporeal membrane oxygenation (ECMO)

Pregnant or lactating women

Previous splenectomy

Any vaccination in the previous 30 days

Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days

Known allergy to study drug or excipients

Weight \>125 kg

Active underlying cancer or treatment with systemic chemotherapy or radiation therapy during the last 60 days or likely to require similar treatments during the ensuing 6 months

Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease

Chronic mechanical ventilation or dialysis

Unsuitable for study participation, in the opinion of the Investigator, because of chronic, severe, end-stage, or life-limiting underlying disease unrelated to current infection likely to interfere with management and assessment of ARDS, only comfort or limited (non-aggressive) care is to be given, or life expectancy \<6 months unrelated to acute infection in the opinion of the Investigator.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Augusta?

Yes, this clinical trial (NCT05947955) has an active research site in Augusta, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Respiratory Distress Syndrome Treatment Options in Augusta, GA

If you're searching for acute respiratory distress syndrome treatment options in Augusta, GA, this clinical trial (NCT05947955) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Augusta research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced acute respiratory distress syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute respiratory distress syndrome clinical trials near you to find additional studies recruiting in your area.

Acute Respiratory Distress Syndrome Clinical Trial in Augusta, GA

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