UMIN-CTR Clinical Trial

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
Email	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
Email	gondake@fmu.ac.jp

Sponsor
Institute	Daido Central Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055652