臨床研究等提出・公開システム

Date of registration	April. 21, 2021
Last modified on	Sept. 04, 2023
Trial ID	jRCT2043210005

Scientific Title	Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infection (Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infection)
Public Title	Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infection (Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infection)

Contact for Scientific Queries	Name	Fukushima Tatsunobu
	Affiliation	Life Science Institute, Inc.
	Address	1-1 Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-8251
	Telephone	+81-3-6748-7200
	E-mail	lsii.chiken-inq@eppharmaline.co.jp
Contact for Public Queries	Name	Call center
	Affiliation	Life Science Institute, Inc.
	Address	1-1 Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-8251
	Telephone	+81-3-6748-7200
	E-mail	lsii.chiken-inq@eppharmaline.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 20, 2021
Target sample size		43
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	-SARS-CoV-2 positive patients by RT-PCR -Patients diagnosed with ARDS by Berlin definition -Patients who are intubated and under mechanical ventilatory control
	Exclusion Criteria	-Patients managed by Extracorporeal Membrane Oxygenation (ECMO) or using ventilation techniques such as High Frequency Oscillatory Ventilation (HFOV) -Patients who are not expected to survive for about 72 hours
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		acute respiratory distress syndrome
Intervention(s)		Single intravenous administration
Primary Outcome(s)		STEP 1 : Safety as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs) STEP 2 : Efficacy as measured by mortality up to 4 weeks after administration

Primary Sponsor	Life Science Institute, Inc.

Name of Certified Review Board	Nagoya University Hospital Institutional review board
Address	65, Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi
Telephone	+81-52-744-1958
E-Mail	center@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 15, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Sept. 04, 2023	(this page)	Changes
5	Aug. 24, 2023	Detail	Changes
4	June. 01, 2022	Detail	Changes
3	Aug. 11, 2021	Detail	Changes
2	April. 22, 2021	Detail	Changes
1	April. 21, 2021	Detail

List of change history