A Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses

NCT07633288 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-07-28

No results posted yet for this study

Summary

A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected to be caused by respiratory viral infection.

Conditions

  • Respiratory Viral Infection

Interventions

DRUG

AP1189, 100 mg

14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment

DRUG

Placebo

14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment

Sponsors & Collaborators

  • SynAct Pharma Aps

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-08-01
Completion
2027-08-01

Countries

  • Bosnia and Herzegovina
  • Montenegro
  • New Zealand
  • Serbia

Study Locations

More Related Trials

Entities

Drugs

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 NCT07633288 on ClinicalTrials.gov