The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia

NCT04263402 | Unknown Phase 4

• 1 other identifier: TJ20200201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.

Conditions

2019-nCoV Severe Pneumonia

Outcome Measures

Primary Outcomes (2)

• Rate of disease remission

  For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2\>93% or PaO2/FiO2 \>300mmHg.

  day 7

• Rate and time of entering the critical stage

  the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.

  day 7

Secondary Outcomes (5)

• Rate of normal tempreture

  day 7

• Rate of respiratory symptom remission

  day 7

• Rate of lung imaging recovery

  day 7

• Rate of laboratory indicator recovery

  day 7

• Rate of undetectable viral RNA

  day 7

Study Arms (2)

Methylprednisolone(<40mg/d)

EXPERIMENTAL

Drug: Methylprednisolone

Methylprednisolone(40~80mg/d)

EXPERIMENTAL

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(\<40mg/d intravenous drip for 7 days).

Methylprednisolone(<40mg/d)

Eligibility Criteria

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

You may qualify if:

• Meet the definition of severe pneumonia(Comply with any of the followings):
• Shortness of breath,RR≥30 bpm;
• In a resting state:SPO2≤93%;
• PaO2/FiO2≤300mmHg.
• nCoV nucleic acid test was positive.
• CT of the lung conformed to the manifestation of viral pneumonia.

You may not qualify if:

• dying state (i.e. survival time is less than 24 hours);
• progressive malignant tumor with life expectancy less than 6 months;
• immunosuppressive status(patients using immunosuppressants or chemotherapeutic drugs)
• underlying diseases requiring long-term glucocorticoid treatment in the past 6 months or short-term glucocorticoid therapy in the past 4 weeks;
• pregnancy
• patients with glucocorticoid taboos

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Department and Institute of Infectious Disease

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Qing Ning, Professor

CONTACT

+8613971521450; qning@vip.sina.com

Meifang Han, Professor

CONTACT

+8613986093605; mfhan@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 10, 2020
• Study Start: February 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

CN (1)