Anti-C5a antibody STSA-1002 for patients with acute respiratory distress syndrome due to viral pneumonia: a phase 1b/2, multicenter, randomized, double-blind, placebo-controlled trial
Abstract
BACKGROUND
ARDS constitutes a major cause of mortality with limited therapeutic options.
RESEARCH QUESTIONS
Whether STSA-1002 is safe and clinically beneficial in ARDS due to viral pneumonia.
STUDY DESIGN AND METHODS
We conducted a phase 1b/2, multi-center, double-blind, placebo-controlled trial. Participants aged between 18 and 85 years, suffering from ARDS due to viral pneumonia, with PaO2/FiO2 ≤ 200mmHg, were included. Patients were randomly assigned (1:1:1) to receive either STSA-1002 1350mg, STSA-1002 750mg or placebo. The STSA-1002 or matched placebo was administered to participants on days 1, 3 and 7, with an optional additional dose on day 14±1 at the physician's discretion. The primary endpoint was time to clinical improvement (TTCI). Clinical improvement was defined as either SpO2/FiO2 > 235 or PaO2/FiO2 > 200 mmHg, maintained for at least 48 hours, whichever occurred first, within 28 days. This trial is registered with ClinicalTrials.gov,NCT06038916.
RESULTS
Between December 9, 2023 and March 20, 2025, 49 patients were enrolled and randomized. Among the 47 patients who received study medication, 17 received STSA-1002 1350mg, 15 received STSA-1002 750mg, and 15 received placebo. The TTCI was 6.0 days in the STSA 1002 1350 mg group, 8.4 days in the STSA 1002 750 mg group and 7.4 days in the control group, with the sHR of 1.55 (95% CI, 0.68-3.55) for the STSA-1002 1350mg group and 1.04 (95% CI, 0.46-2.38) for STSA-1002 750mg group according to a competing risk model,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 47 participants or records.
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