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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045825


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name