Adaptive RCT of Corticosteroids for Severe Adenovirus Pneumonia in Adults

NCT07152600 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2025-I2M-C&T-B-090A
• Study Type: interventional
• Target: 262
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Adenovirus; community-acquired pneumonia; adaptive randomised controled trial; corticosteroids

Outcome Measures

Primary Outcomes (1)

• 28-day all cause mortality

  28 days from inclusion

Study Arms (3)

Standard of Care

PLACEBO COMPARATOR

Control group

Drug: Saline (0.9%, sterile, for infusion)

Low dose steroids

EXPERIMENTAL

treated with low dose corticosteroids

Drug: low dose Methylprednisolone

Moderate dose steroids

EXPERIMENTAL

treated with moderate dose corticosteroids

Drug: Moderate dose Methylprednisolone

Interventions

Saline (0.9%, sterile, for infusion) DRUG

Sailine as control

Standard of Care

low dose Methylprednisolone DRUG

Methylprednisolone 0.5mg/kg ivgtt qd

Low dose steroids

Moderate dose Methylprednisolone DRUG

Methylprednisolone 1.0mg/kg ivgtt qd

Moderate dose steroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Admission to the Intensive Care Unit (ICU).
• Meeting the diagnostic criteria for community-acquired pneumonia (CAP).
• Meeting at least one of the major diagnostic criteria for severe pneumonia:
• (i) Requirement for endotracheal intubation and mechanical ventilation;
• (ii) Septic shock requiring vasopressor therapy after adequate fluid resuscitation.
• Or simultaneously fulfilling three of the minor criteria:
• (i) Respiratory rate ≥ 30 breaths/min;
• (ii) PaO₂/FiO₂ ≤ 250 mmHg;
• (iii) Multilobar infiltrates;
• (iv) Altered mental status and/or disorientation;
• (v) Blood urea nitrogen ≥ 20 mg/dL (7.12 mmol/L);
• (vi) Leukopenia (white blood cell count \< 4 × 10⁹/L);
• (vii) Thrombocytopenia (platelet count \< 100 × 10⁹/L);
• (viii) Hypothermia (core temperature \< 36 °C);

You may not qualify if:

• Patients receiving vasopressor therapy for septic shock at the time of enrollment.
• Terminally ill patients (expected survival \<30 days, e.g., advanced malignancy).
• Clinical history suggesting overt aspiration.
• Documented active gastrointestinal bleeding.
• Presence of cystic fibrosis, obstructive pneumonia, active influenza, pulmonary tuberculosis, or fungal infection.
• Active viral hepatitis or active herpesvirus infection.
• Bone marrow suppression or HIV infection.
• Refusal of mechanical ventilation and endotracheal intubation.
• Uncontrolled hyperglycemia (diabetic ketoacidosis with blood ketones \>3 mmol/L, or hyperosmolar hyperglycemic state with blood glucose \>33.3 mmol/L and elevated osmolality).
• Known allergy to corticosteroids.
• Patients requiring anti-inflammatory corticosteroids or replacement hydrocortisone for any reason, or those already receiving prednisone \>15 mg/day (or equivalent dose of another corticosteroid).
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Qingyuan Zhan: lead

MeSH Terms

Conditions

Adenovirus Infections, Human; Adenoviridae Infections; Community-Acquired Pneumonia

Interventions

Sodium Chloride; Methylprednisolone

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Community-Acquired Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-08