NCT07152600

Adaptive RCT of Corticosteroids for Severe Adenovirus Pneumonia in Adults

An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Severe Adenovirus Community-Acquired Pneumonia in Adults

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (estimated)
• Sponsor: Qingyuan Zhan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Adenovirus Infections, Human

Interventions

Type	Name	Description
DRUG	Saline (0.9%, sterile, for infusion)	Sailine as control
DRUG	low dose Methylprednisolone	Methylprednisolone 0.5mg/kg ivgtt qd
DRUG	Moderate dose Methylprednisolone	Methylprednisolone 1.0mg/kg ivgtt qd

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2025-09-03
• Last updated: 2026-01-21