臨床研究等提出・公開システム

Date of registration	June. 24, 2021
Last modified on	June. 24, 2021
Trial ID	jRCT2071210038

Scientific Title	Prevention of aggravation of moderate pneumonia caused by COVID - 19 using adrenomedullin - Investigator initiated phase 2a trial (AM-P2-COVID2)
Public Title	Therapeutic development of adrenomedullin for moderate pneumonia caused by COVID-19

Contact for Scientific Queries	Name	Kita Toshihiro
	Affiliation	University of Miyazaki
	Address	5200 Kihara, Kiyotake, Miyazaki, Miyazaki
	Telephone	+81-985-85-9614
	E-mail	toshihiro_kita@med.miyazaki-u.ac.jp
Contact for Public Queries	Name	Kita Toshihiro
	Affiliation	University of Miyazaki
	Address	5200 Kihara, Kiyotake, Miyazaki, Miyazaki
	Telephone	+81-985-85-9614
	E-mail	toshihiro_kita@med.miyazaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 24, 2021
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Hospitalized patients with moderate COVID-19 pneumonia and within 10 days after onset
	Exclusion Criteria	patients with severe COVID-19 pneumonia 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
	Age Minimum	20age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		COVID-19
Intervention(s)		Intravenous infusion of investigative drug (adrenomedullin or placebo) will be started immediately after the allocation of the patient. 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 oxygen administration.
Health Condition(s) Code		COVID-19
Primary Outcome(s)		Period of oxygen administration (days)
Secondary Outcome(s)		the distribution of clinical status assessed on the 6-point ordinal scale on study day 10, 20 and 30 The changes of cytokines Adverse events

Source of Monetary Support	Japan Agency for Medical Research and Development

Name of Certified Review Board	Institutional Review Board of the University of Miyazaki
Address	5200 Kihara, Kiyotake, Miyazaki, Miyazaki, Miyazaki
Telephone	+81-985-85-9852
E-Mail	chiken-jimu@med.miyazaki-u.ac.jp
Approval Status	Approval
Date of approval	April. 28, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none