Is NCT06999603 recruiting in Naples, FL?

Yes, NCT06999603 is currently recruiting participants at its Naples, FL location. This viral pneumonia clinical trial is actively enrolling qualified participants.

How do I join the viral pneumonia clinical trial in Naples?

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

Is participation in this Naples 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.

Viral Pneumonia Clinical Trial in Naples, FL

About This Viral Pneumonia Study in Naples

The goal of this Phase 2 study is to assess about the safety, antiviral biomarker responses and efficacy of SNG001 when given to patients requiring invasive mechanical ventilation due to a respiratory virus infection. Its ability to speed up virus clearance and reduce mortality, compared with standard of care, will be studied. The study is split into two parts. All participants will receive standard of care in addition to SNG001 or placebo. In Part 1, the safety of SNG001 will be assessed. Participants of 50 years and older will receive study drug or placebo once a day for up to 14 days, whilst in hospital. In Part 2, the primary objective will be the efficacy of SNG001. Participants between 18 and 50 years with an immunocompromising condition and patients over 50 years (with or without an immunocompromising condition) will receive study drug once a day for up to 14 days, whilst in hospital.

Sponsor: Synairgen Research Ltd.

Who Can Participate

Inclusion Criteria

To be eligible for randomisation into Part 1 of this study, each participant must fulfil the following criteria:

Informed consent or legal representative's consent obtained.

Patients ≥50 years of age at the time of consent.

Patient admitted to the ICU and requiring invasive mechanical ventilation (IMV) due to a respiratory virus infection.

Presence of Influenza A (Flu A), Influenza B (Flu B), respiratory syncytial virus (RSV), rhinovirus (RV), adenovirus, parainfluenza, human metapneumovirus (HMPV), or coronaviruses (including SARS-COV-2 and seasonal coronaviruses) in a nose swab sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., reverse transcription polymerase chain reaction \[RT-PCR\]).

Time from intubation to administration of first dose of study medication ≤48 hours.

Women of childbearing potential must have a negative pregnancy test. For this study, women of childbearing potential are defined as women \<55 years old. Part 1

Exclusion Criteria

A participant must not be randomised into Part 1 of the study if they meet any of the following criteria:

Expected termination of IMV within 24 hours from the time of randomisation

Life expectancy \<24 hours.

Liver failure (Child-Pugh C).

Severe congestive heart failure (New York Heart Association \[NYHA\] IV).

Receipt of lung transplant.

Known or suspected active tuberculosis, or infection with other mycobacteria

Known or suspected active systemic fungal infection.

Anticipated transfer to another hospital which would prevent the participant from continuing in the study and completing protocol assessments.

Need for long-term mechanical ventilation prior to ICU admission.

Use of inhaled sedation.

Presence of tracheostomy or laryngectomy.

Requirement for airway pressure release ventilation mode.

History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation.

Any condition, including findings in the patient's medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation.

Participation in previous clinical studies of SNG001.

Current or previous participation in another clinical study where the participant has received a dose of an Investigational Medicinal Product (IMP) containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study.

Known or suspected pregnancy.

Females who are breast-feeding or lactating.

Immunocompromising condition, including:

Established acquired immune deficiency syndrome (AIDS) defined as a cluster of differentiation 4 (CD4) count \<200 cells/microL, and/or the presence of any AIDS-defining condition;

Haematological malignancy;

Bone marrow transplantation; or

Immunosuppressive therapy, including:

Cancer therapy (e.g. chemo-, radio-, immuno-, hormone or other types of therapy), immune-cell depleting therapy, immunosuppressive therapy for autoimmune disorders, medications for prevention of organ transplantation rejection, administered within 6 months prior to randomisation; or

Corticosteroids \>20 mg of prednisone or equivalent per day administered continuously for \>14 days prior to randomisation.

Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis. Part 2 Inclusion Criteria: To be eligible for randomisation into Part 2 of this study, each participant must fulfil the following criteria: 1.a Patients ≥18 and \<50 years of age at the time of consent, with an immunocompromising condition, including:

Solid tumour malignancy undergoing cancer therapy (e.g. chemo-, radio-, immuno-, hormone or other types of therapy);

Haematological malignancy in remission, with or without maintenance therapy;

Immunosuppressive therapy for autoimmune disease;

Therapy for prevention of organ transplant rejection;

Corticosteroids \>20 mg of prednisone or equivalent per day, administered continuously for \>14 days prior to randomisation or

b Patients ≥50 years of age at the time of consent, with or without an immunocompromising condition (as defined above).

Patient admitted to the ICU and requiring IMV due to a respiratory virus infection.

Presence of Flu A, Flu B, RSV, RV, adenovirus, parainfluenza, HMPV, or coronaviruses (including SARS-COV-2 and seasonal coronaviruses) in a Lower Respiratory Tract sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., RT-PCR).

Time from intubation to administration of first dose of study medication ≤48 hours.

Informed consent or legal representative's consent obtained.

Women of childbearing potential must have a negative pregnancy test. For this study, women of childbearing potential are defined as women \<55 years old. Part 2 Exclusion Criteria: A participant must not be randomised into Part 2 of the study if they meet any of the following criteria:

Expected termination of IMV within 24 hours from the time of randomisation.

Life expectancy \<24 hours.

Liver failure (Child-Pugh C).

Severe congestive heart failure (NYHA IV).

Receipt of lung transplant.

Known or suspected active tuberculosis, or infection with other mycobacteria.

Known or suspected systemic fungal infection.

Immunocompromising condition, including:

Haematological malignancy requiring induction or consolidation therapy within 3 months prior to randomisation;

Bone marrow transplant within 6 months prior to randomisation;

Solid organ transplant within 6 months prior to randomisation;

Corticosteroids \>75 mg of prednisone or equivalent per day, administered continuously for \>7 days prior to randomisation;

Methotrexate therapy at randomisation, if the indication is chemotherapy for cancer;

Chimeric antigen receptor (CAR)-T cell therapy, administered within 3 months prior to randomisation;

Ibrutinib or alemtuzumab, administered within 3 months prior to randomisation;

Neutropenia \<500/mm3 not due to sepsis;

Clinical presentation consistent with severe bone marrow suppression or pancytopenia;pancytopenia;

Established AIDS, defined as a CD4 count \<200 cells/microL, and/or the presence of any AIDS-defining condition.

Anticipated transfer to another hospital which would prevent the participant from continuing in the study and completing protocol assessments.

Need for long-term mechanical ventilation prior to ICU admission.

Use of inhaled sedation.

Presence of tracheostomy or laryngectomy

History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation.

Participation in previous clinical studies of SNG001.

Current or previous participation in another clinical study where the participant has received a dose of an IMP containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study.

Known or suspected pregnancy.

Females who are breast-feeding or lactating.

Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis

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 Naples?

Yes, this clinical trial (NCT06999603) has an active research site in Naples, FL 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.

Viral Pneumonia Treatment Options in Naples, FL

If you're searching for viral pneumonia treatment options in Naples, FL, this clinical trial (NCT06999603) 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 Naples research site is actively enrolling participants for this clinical trial. You'll receive care from experienced viral pneumonia 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 viral pneumonia clinical trials near you to find additional studies recruiting in your area.

Viral Pneumonia Clinical Trial in Naples, FL

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