CX-4945 in Viral Community Acquired Pneumonia

Sponsor
Senhwa Biosciences, Inc.
Study ID
NCT06202521
Phase
PHASE2
Status
Terminated

Conditions

  • Community-acquired Pneumonia
  • Influenza With Pneumonia
  • SARS-CoV-2 -Associated Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CX-4945 (SARS-CoV-2 domain) — DRUG
    CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.
  • Placebo (SARS-CoV-2 domain) — DRUG
    The dosage and frequency is the same as active drug.
  • CX-4945 (Influenza virus domain) — DRUG
    CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.
  • Placebo (Influenza virus domain) — DRUG
    The dosage and frequency is the same as active drug.

Study Details

This is a Phase II, multi-center, double-blind, randomized, interventional study in approximately 120 subjects to evaluate clinical benefit of CX-4945 in adult outpatients with SARS-CoV-2 and influenza viral infection-associated pneumonia. The subjects will be recruited into two domains, including SARS-CoV-2 and influenza virus domains. The study will compare the efficacy of Standard of Care (SOC) combined with CX-4945 against SOC paired with a placebo, utilizing a 1:1 allocation ratio in each domain.

Key Dates

Start date
Mar 20, 2024
Status verified
Dec 2025
Primary completion
Apr 22, 2025
Completion
Apr 22, 2025

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SARS-CoV-2 domain: CX-4945 (400 mg BID for 5 days) +SOC
    Notes: The SOC within the SARS-CoV-2 domain is defined as the medications in use at each respective site for the treatment of CAP related to SARS-CoV-2 infection.
  • Placebo Comparator: SARS-CoV-2 domain: Placebo + SOC
    Notes: The SOC within the SARS-CoV-2 domain is defined as the medications in use at each respective site for the treatment of CAP related to SARS-CoV-2 infection.
  • Experimental: Influenza virus domain: CX-4945 (400 mg BID for 5 days) +SOC
    Notes: The SOC within the influenza virus domain is defined as the medications in use at each respective site for the treatment of CAP related to influenza virus infection.
  • Placebo Comparator: Influenza virus domain: Placebo + SOC
    Notes: The SOC within the influenza virus domain is defined as the medications in use at each respective site for the treatment of CAP related to influenza virus infection.

Primary Outcome Measure

The Percentage of Subjects Requiring Hospitalization, Including Emergency Room Visits, or Resulting in Death Due to Progression of CAP Related to SARS-CoV-2 or Influenza. [ Time Frame: Day 1 to Day 29 ]

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