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Adaptive RCT of Corticosteroids for Severe Adenovirus Pneumonia in Adults

Study acronym: CAPSTONE-AD
StatusNot Yet Recruiting
PhasePhase 3
Started
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Record History

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  1. Notable Start date: Sep 8, 2025 to Feb 1, 2026
    • Eligibility criteria shortened, about 3 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Severe community-acquired pneumonia caused by adenovirus (hereafter referred to as severe adenovirus pneumonia) is one of the common forms of severe community-acquired pneumonia in immunocompetent adults. It predominantly affects young individuals, progresses rapidly, and is associated with a high incidence of respiratory failure and multiple organ dysfunction. At present, there is no effective antiviral therapy available in China, and the reported mortality rate ranges from 41.5% to 80%. How to effectively reduce the mortality of severe adenovirus pneumonia, on the basis of conventional supportive care, is crucial for improving the prognosis of critically ill patients and alleviating the burden on families and society. We are currently conducting an adaptive, randomized, open-label controlled trial aimed at reducing mortality in severe adenovirus pneumonia. The primary objective of this study is to evaluate the efficacy and safety of adjunctive corticosteroid therapy at different dosages, in addition to early standard supportive treatment, in lowering mortality among patients with severe adenovirus pneumonia.
Trial Details
NCT Number NCT07152600
Lead Sponsor Qingyuan Zhan
Conditions
(from sponsor)
Adenovirus Infections, Human
Related terms Adenoviridae Infections, Adenovirus Infections, Human, Community-Acquired Pneumonia
Enrollment 262 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov