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CX-4945 in Viral Community Acquired Pneumonia

NCT06202521 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-01-08

Study results available
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Summary

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.

Conditions

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

Interventions

DRUG

CX-4945 (SARS-CoV-2 domain)

CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.

DRUG

Placebo (SARS-CoV-2 domain)

The dosage and frequency is the same as active drug.

DRUG

CX-4945 (Influenza virus domain)

CX-4945 will be administered at 400 mg BID for up to 5 days (Day 1 to Day 5) in addition to SOC.

DRUG

Placebo (Influenza virus domain)

The dosage and frequency is the same as active drug.

Sponsors & Collaborators

  • Senhwa Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Jason Huang, M.D. · Senhwa Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2025-04-22
Completion
2025-04-22
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06202521 on ClinicalTrials.gov