UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040188 |
|---|---|
| Receipt number | R000045825 |
| Scientific Title | Chloroquine and hydroxychloroquine for treatment of COVID-19: systematic review of randomized and non-randomized controlled trial |
| Date of disclosure of the study information | 2020/04/17 |
| Last modified on | 2021/12/20 12:21:02 |
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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
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
horitano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045825
