UMIN-CTR Clinical Trial

Basic information
Public title	Chloroquine and hydroxychloroquine for treatment of COVID-19: systematic review of randomized and non-randomized controlled trial
Acronym	Chloroquine and hydroxychloroquine for treatment of COVID-19: systematic review of randomized and non-randomized controlled trial
Scientific Title	Chloroquine and hydroxychloroquine for treatment of COVID-19: systematic review of randomized and non-randomized controlled trial
Scientific Title:Acronym	Chloroquine and hydroxychloroquine for treatment of COVID-19: systematic review of randomized and non-randomized controlled trial
Region	Japan North America

Condition
Condition	COVID-19
Classification by specialty	Medicine in general Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the impact of CQ/HCQ on COVID-19
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	All cause death (odds ratio). Viral clearance on day 7
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	COVID-19
Key exclusion criteria	None
Target sample size

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Horita
Organization	Yokohama City University School of Medicine
Division name	Department of Pulmonology
Zip code	236-0004
Address	3-9 Fukuura Kanazawa Yokohama
TEL	0457872800
Email	horitano@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Nobuyuki Middle name Last name Horita
Organization	Yokohama City University School of Medicine
Division name	Department of Pulmonology
Zip code	236-0004
Address	3-9 Fukuura Kanazawa Yokohama
TEL	0457872800
Homepage URL
Email	horitano@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization	Yokohama City University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University School of Medicine
Address	3-9 Fukuura Kanazawa Yokohama
Tel	0457872800
Email	horitano@yokohama-cu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	2063
Results	Please see: J Thorac Dis. 2021 Jan;13(1):202-212.
Results date posted	2021 Year 12 Month 20 Day
Results Delayed
Results Delay Reason	Please see: J Thorac Dis. 2021 Jan;13(1):202-212.
Date of the first journal publication of results
Baseline Characteristics	Please see: J Thorac Dis. 2021 Jan;13(1):202-212.
Participant flow	Please see: J Thorac Dis. 2021 Jan;13(1):202-212.
Adverse events	Please see: J Thorac Dis. 2021 Jan;13(1):202-212.
Outcome measures	Please see: J Thorac Dis. 2021 Jan;13(1):202-212.
Plan to share IPD	Please see: J Thorac Dis. 2021 Jan;13(1):202-212.
IPD sharing Plan description	Please see: J Thorac Dis. 2021 Jan;13(1):202-212.

Progress
Recruitment status	Main results already published
Date of protocol fixation	2020 Year 04 Month 17 Day
Date of IRB	2020 Year 04 Month 17 Day
Anticipated trial start date	2020 Year 04 Month 17 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Search: PubMed, Web of Science, Cochrane database, EMBASE, and MedRxiv will be searched on April 15, 2020. Hand search will be also done. Type of study Randomized and non-randomized controlled trial. A randomized study with preliminary or interim analysis will be allowed. Outcome Viral clearance. Symptom alleviation. CT improvement. Disease progression. Any AE. Severe AE. Death from any cause. Patient COVID-19 patient confirmed with PCR and strongly suspected based on clinical information. Treatment Chloroquine and Hydroxychloroquine with or without Azithromycin

Management information
Registered date	2020 Year 04 Month 17 Day
Last modified on	2021 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045825