Trial results for the Phase 2 study (NCT04415151) investigating tofacitinib for the treatment of moderate COVID-19 pneumonia were posted on ClinicalTrials.gov on 2025-03-28. The study, which enrolled 24 participants, was ultimately terminated.
Background
The study, titled "Tofacitinib for Treatment of Moderate COVID-19," aimed to assess the efficacy and safety of tofacitinib in hospitalized adult patients (18-99 years old) with SARS-CoV-2 and pneumonia. These patients required supplemental oxygen and had serologic markers of inflammation but did not need mechanical ventilation.
Trial design
The study (NCT04415151) was a Phase 2, randomized, double-blinded, placebo-controlled trial. It enrolled 24 participants diagnosed with COVID-19 Pneumonia. Participants were randomized to receive either tofacitinib 10 mg or placebo. The study's overall status is terminated.
Key results
The trial collected data on "Disease Severity" and "Clinical Improvement (Last Measure)." For "Disease Severity," 5 participants were reported in the Placebo group and 10 participants in the Tofacitinib group. For "Clinical Improvement (Last Measure)," the following participant counts were observed:
- Placebo group: 1 participant, 0 participants, 2 participants, 3 participants, 0 participants
- Tofacitinib group: 1 participant, 1 participant, 0 participants, 1 participant, 0 participants
What this means
The termination of this Phase 2 study for tofacitinib in moderate COVID-19 pneumonia means that the trial did not proceed to completion as originally planned. The posted results, consisting of participant counts for "Disease Severity" and "Clinical Improvement," are incomplete and do not provide sufficient data to draw conclusions regarding the efficacy or safety of tofacitinib for this indication. Further research would be needed to evaluate its potential role in treating COVID-19 pneumonia.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04415151, titled "Tofacitinib for Treatment of Moderate COVID-19," were posted on 2025-03-28 on clinicaltrials.gov.