Japanease

Oct. 12, 2020

Feb. 08, 2021

jRCT2071200041

Prevention of aggravation of mechanical ventilation required pneumonia caused by COVID - 19 using adrenomedullin - Investigator initiated phase 2a trial (AM-P2-COVID)

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

Kita Toshihiro

Faculty of Medicine, University of Miyazaki

5200 Kihara, Kiyotake, Miyazaki, Miyazaki

+81-895-85-0872

toshihiro_kita@med.miyazaki-u.ac.jp

Kita Toshihiro

Faculty of Medicine, University of Miyazaki

5200 Kihara, Kiyotake, Miyazaki, Miyazaki

+81-895-85-0872

toshihiro_kita@med.miyazaki-u.ac.jp

Nov. 25, 2020

40

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

none

patients with mechanical ventilation required pneumonia caused by COVID-19

patients 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

20age old over
75age old under

Both

COVID-19

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.

Period of mechanical ventilation (days)

the distribution of clinical status assessed on the 6-point ordinal scale on study day 15 and 30
The changes of cytokines
Adverse events

Recruiting

Japan Agency for Medical Research and Development
Institutional Review Board of the University of Miyazaki
5200 Kihara, Kiyotake, Miyazaki, Miyazaki

+81-985-85-9852

chiken-jimu@med.miyazaki-u.ac.jp
Approval

Aug. 27, 2020

No