UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048841 |
|---|---|
| Receipt number | R000055652 |
| Scientific Title | Therapeutic Effects of Clarithromycin Combined with Molnupiravir in Management of Mild to Moderate COVID-19 Hospitalized Patients: a case control study |
| Date of disclosure of the study information | 2022/12/31 |
| Last modified on | 2022/09/02 22:49:48 |
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Basic information
Public title
Therapeutic Effects of Clarithromycin and Molnupiravir in Management of COVID-19 Patients
Acronym
Therapeutic Effects of Clarithromycin and Molnupiravir
Scientific Title
Therapeutic Effects of Clarithromycin Combined with Molnupiravir in Management of Mild to Moderate COVID-19 Hospitalized Patients: a case control study
Scientific Title:Acronym
Therapeutic Effects of Clarithromycin Combined with Molnupiravir in Management of Mild to Moderate COVID-19 Hospitalized Patients
Region
| Japan |
Condition
Condition
COVID-19 patients
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Therapeutic Effects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
On the day SARS-CoV-2 positivity was detected, mild or asymptomatic COVID-19 patients were administered molnupiravir for 5 or 7 days, and those with respiratory symptoms were co-administered with CAM for 3 days
Key secondary outcomes
Prognostic effect of combined administration of molnupiravir plus clarithromycin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with respiratory symptoms (n=54) received concurrent administration of Clarithromycin (400 mg per day; 200 mg twice daily for 3 days), and asymptomatic patients (n=37) received molnupiravir alone
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
| 3 | days-old | <= |
Age-upper limit
| 5 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with respiratory symptoms were administered Clarithromycin in combination, and asymptomatic patients were administered molnupiravir alone.
Key exclusion criteria
not Mild or moderate patient
Target sample size
119
Research contact person
Name of lead principal investigator
| 1st name | KENJI |
| Middle name | |
| Last name | GONDA |
Organization
Daido Central Hospital
Division name
Surgery
Zip code
9020067
Address
1-1-37 Asato, Naha City, Okinawa
TEL
0988690005
gondake@fmu.ac.jp
Public contact
Name of contact person
| 1st name | KENJI |
| Middle name | |
| Last name | GONDA |
Organization
Daido Central Hospital
Division name
Surgery
Zip code
902-0067
Address
1-1-37 Asato, Naha City, Okinawa
TEL
0988690005
Homepage URL
gondake@fmu.ac.jp
Sponsor or person
Institute
Daido Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Daido Central Hospital
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
Daido Central Hospital
Address
1-1-37 Asato, Naha City, Okinawa
Tel
0988690005
gondake@fmu.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
| 2022 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
119
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 02 | Day |
Last modified on
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055652
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
