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Not yet recruitingNCT07152600CAPSTONE-ADUpdated Jan 21, 2026

Adaptive RCT of Corticosteroids for Severe Adenovirus Pneumonia in Adults

A Phase 3 interventional study of Saline (0.9%, sterile, for infusion) and low dose Methylprednisolone in Adenovirus Infections, Human, sponsored by Qingyuan Zhan. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Qingyuan Zhan · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
262
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Adenovirus Infections, Human

Keywords

  • Adenovirus
  • community-acquired pneumonia
  • adaptive randomised controled trial
  • corticosteroids
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In context

Adenoviridae Infections

104 studies on the registry are indexed under Adenoviridae Infections; 32 are open to participants now.

This study's planned enrollment of 262 is above the median of 36 across 80 interventional studies indexed under Adenoviridae Infections.

Browse Adenoviridae Infections studies →

Lead sponsor

Qingyuan Zhan is the lead sponsor of 7 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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);

(ix) Hypotension (systolic blood pressure \< 90 mmHg) requiring aggressive fluid resuscitation.

  • Confirmed adenovirus etiology: at least one positive nucleic acid test (PCR) or next-generation sequencing (NGS) result for adenovirus in respiratory specimens (respiratory secretions, throat swabs, or bronchoalveolar lavage fluid).
  • Severe community-acquired pneumonia (SCAP) patients admitted to the emergency department/ward/ICU due to respiratory failure within \< 72 hours.
  • Signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
262 participants (estimated)

Study arms

  • Placebo comparator
    Standard of Care

    Control group

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

  • Experimental
    Low dose steroids

    treated with low dose corticosteroids

    Drug: low dose Methylprednisolone

  • Experimental
    Moderate dose steroids

    treated with moderate dose corticosteroids

    Drug: Moderate dose Methylprednisolone

Interventions

  • DrugSaline (0.9%, sterile, for infusion)

    Sailine as control

  • Druglow dose Methylprednisolone

    Methylprednisolone 0.5mg/kg ivgtt qd

  • DrugModerate dose Methylprednisolone

    Methylprednisolone 1.0mg/kg ivgtt qd

06

What researchers measure

Primary outcomes

  1. 28-day all cause mortality

    Time frame: 28 days from inclusion

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07152600
Lead sponsor
Qingyuan Zhan
Responsible party
Qingyuan Zhan (Director, China-Japan Friendship Hospital) — Sponsor-investigator
First posted
Sep 3, 2025
Start date
Feb 1, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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