NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071200041

Registered date:12/10/2020

Therapeutic development of adrenomedullin for severe pneumonia caused by COVID-19

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCOVID-19
Date of first enrollment25/11/2020
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Intravenous infusion of investigative drug (adrenomedullin or placebo) will be started immediately after the introduction of mechanical ventilation. The administration of the drug are maintained 72 hour and then intermittent administration (8 hours per day) are followed up to 10 days. The drug administration will be stop after withdrawal of mechanical ventilation.

Outcome(s)

Primary OutcomePeriod of mechanical ventilation (days)
Secondary Outcomethe distribution of clinical status assessed on the 6-point ordinal scale on study day 15 and 30 The changes of cytokines Adverse events

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteriapatients with mechanical ventilation required pneumonia caused by COVID-19
Exclude criteriapatients with liver dysfunction (AST and/or ALT > 5 times of reference values) patients with renal dysfunction (serum creatinine > 2.0 mg/dl) patients with severe ECG abnormalities and/or cardiac diseases patients with malignancy or history of malignancy patients who are expected to transfer to other hospital within 72 hours pregnant or lactating women

Related Information

Contact

Public contact
Name Toshihiro Kita
Address 5200 Kihara, Kiyotake, Miyazaki, Miyazaki Miyazaki Japan 889-1692
Telephone +81-895-85-0872
E-mail toshihiro_kita@med.miyazaki-u.ac.jp
Affiliation Faculty of Medicine, University of Miyazaki
Scientific contact
Name Toshihiro Kita
Address 5200 Kihara, Kiyotake, Miyazaki, Miyazaki Miyazaki Japan 889-1692
Telephone +81-895-85-0872
E-mail toshihiro_kita@med.miyazaki-u.ac.jp
Affiliation Faculty of Medicine, University of Miyazaki