UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056060
Receipt number R000064062
Scientific Title Experience of inpatient treatment of 900 COVID-19 cases at our hospital: Responses and challenges from the first wave to the seventh wave
Date of disclosure of the study information 2024/11/05
Last modified on 2024/11/06 10:27:07

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Basic information

Public title

Experience of inpatient treatment of 900 COVID-19 cases at our hospital: Responses and challenges from the first wave to the seventh wave

Acronym

Experience of inpatient treatment of 900 COVID-19 cases at our hospital: Responses and challenges from the first wave to the seventh wave

Scientific Title

Experience of inpatient treatment of 900 COVID-19 cases at our hospital: Responses and challenges from the first wave to the seventh wave

Scientific Title:Acronym

Experience of inpatient treatment of 900 COVID-19 cases at our hospital: Responses and challenges from the first wave to the seventh wave

Region

Japan


Condition

Condition

COVID-19

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Based on our clinical experience at our hospital, we investigated the challenges facing inpatient treatment for COVID-19.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Issues in inpatient treatment

Key secondary outcomes



Base

Study type

Observational


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

900 cases admitted to our hospital with COVID-19 from March 2020 to September 2022

Key exclusion criteria

Seven suspected cases, 31 close contacts, three false positives, and 19 cases after release from quarantine were excluded.

Target sample size

900


Research contact person

Name of lead principal investigator

1st name Kotaro
Middle name
Last name Kajiwara

Organization

Matsuyama Red Cross Hospital

Division name

Department of Respiratory Medicine

Zip code

7908524

Address

1 Bunkyo, Matsuyama, Ehime, Japan.

TEL

0899241111

Email

respiratory24@outlook.jp


Public contact

Name of contact person

1st name Kotaro
Middle name
Last name Kajiwara

Organization

Matsuyama Red Cross Hospital

Division name

Department of Respiratory Medicine

Zip code

7908524

Address

1 Bunkyo, Matsuyama, Ehime, Japan.

TEL

0899241111

Homepage URL


Email

respiratory24@outlook.jp


Sponsor or person

Institute

Matsuyama Red Cross Hospital

Institute

Department

Personal name



Funding Source

Organization

Matsuyama Red Cross Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Matsuyama Red Cross Hospital

Address

1 Bunkyo, Matsuyama, Ehime, Japan.

Tel

0899241111

Email

respiratory24@outlook.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

2024 Year 11 Month 05 Day


Related information

URL releasing protocol

http://www.matsuyama.jrc.or.jp/

Publication of results

Published


Result

URL related to results and publications

http://www.matsuyama.jrc.or.jp/

Number of participants that the trial has enrolled

900

Results

As evidence accumulates, inpatient medical treatments such as drug therapy and oxygen therapy have changed, and multiple problems have emerged, including: 1) shortages of supplies, 2) shortages of personnel, 3) shortages of hospital beds, 4) social issues, 5) dealing with minorities, and 6) restrictions due to infection control measures.

Results date posted

2024 Year 11 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

We conducted a retrospective analysis using medical records of 900 patients who were hospitalized with COVID-19 at our hospital between March 2020 and September 2022.

Participant flow

Our hospital handles pediatric and obstetric hospitalizations, and young patients include children with febrile convulsions and pregnant women in the perinatal period. During the seventh wave, the elderly of hospitalized patients was observed.

Adverse events

There were multiple problems, including: 1) shortage of supplies, 2) shortage of personnel, 3) shortage of hospital beds, 4) social issues, 5) dealing with minorities, and 6) restrictions due to isolation.

Outcome measures

We investigated the challenges in inpatient care for COVID-19.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2023 Year 03 Month 31 Day

Date of IRB

2023 Year 03 Month 31 Day

Anticipated trial start date

2023 Year 03 Month 31 Day

Last follow-up date

2023 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We conducted a retrospective analysis using medical records of 900 patients who were hospitalized with COVID-19 at our hospital between March 2020 and September 2022.


Management information

Registered date

2024 Year 11 Month 05 Day

Last modified on

2024 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064062