Adaptive RCT of Corticosteroids for Severe Adenovirus Pneumonia in Adults

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorQingyuan Zhan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Admission to the Intensive Care Unit (ICU).

Meeting the diagnostic criteria for community-acquired pneumonia (CAP).

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saline (0.9%, sterile, for infusion)

    Drug

    Sailine as control

  • low dose Methylprednisolone

    Drug

    Methylprednisolone 0.5mg/kg ivgtt qd

  • Moderate dose Methylprednisolone

    Drug

    Methylprednisolone 1.0mg/kg ivgtt qd

Treatment groups

262 Participants
are divided into 3 treatment groups
Group A: Standard of CarePlacebo comparator 1 intervention
Group B: Low dose steroidsExperimental treatment 1 intervention
Group C: Moderate dose steroidsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

28-day all cause mortality

Time frame
28 days from inclusion

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qingyuan Zhan

Lead sponsor

China-Japan Friendship Hospital

Sponsor institution

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