UMIN-CTR Clinical Trial

Basic information
Public title	Immunological efficacy of Qing Fei Pai Du Tang for COVID-19
Acronym	COVID-19/Qing Fei Pai Du Tang
Scientific Title	Immunological efficacy of Qing Fei Pai Du Tang for COVID-19: an open-label, single-arm trial
Scientific Title:Acronym	COVID-19/Qing Fei Pai Du Tang
Region	Japan

Condition
Condition	COVID-19
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A rapid increase in the numbers of patients with and deaths from COVID-19 is becoming a global threat to public health. One of the reasons for the current pandemic is that effective vaccine or specific drugs against COVID-19 remain unavailable. In China, traditional Chinese herbal medicine has been integrated into the official therapeutic protocols against COVID-19. The Qing Fei Pai Du Tang (QFPDT) is a Chinese multi-herbal formula newly developed and optimized specifically for patients with COVID-19. Recent clinical trials in China have demonstrated that the QFPDT successfully alleviates COVID-19 symptoms in a large number of mild to critical cases. However, the underlying pharmacological mechanism and the feasibility of prophylactic use in uninfected individuals remain unknown. We thus examine whether hematological and immunological parameters of healthy individuals are affected by the low-dose administration of QFPDT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma cytokine levels after administration of Qing Fei Pai Du Tang for 3 days
Key secondary outcomes	Hematology and blood biochemistry after administration of Qing Fei Pai Du Tang for 3 days

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	We reduce the dose of each herb to 1/30 to explore the feasibility of prophylactic use. The QFPDT decoction is prepared by boiling the mixed herbs in 600 ml of water for 1 h and divided into six aliquots. The subjects are instructed to take the aliquot of the decoction orally 40 min after each breakfast and dinner for 3 days.
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	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy volunteers
Key exclusion criteria	Current infectious, inflammatory, or immune-related diseases
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Tsutomu Middle name Last name Nakamura
Organization	Institute for Quantitative Biosciences, The University of Tokyo
Division name	Laboratory of Molecular and Genetic Information
Zip code	113-0032
Address	1-1-1, Yayoi, Bunkyo-ku, Tokyo
TEL	03-5841-7834
Email	nakamurachibiko@gmail.com

Public contact
Name of contact person	1st name Tomoka Middle name Last name Ebisui
Organization	Takanawa Clinic
Division name	Administration Department
Zip code	140-0001
Address	1-22-17, Kitashinagawa, Shinagawa-ku, Tokyo
TEL	03-6433-3165
Homepage URL
Email	jimukyoku@takanawa-clinic.com

Sponsor
Institute	Administration Department, Takanawa Clinic
Institute
Department

Funding Source
Organization	Administration Department, Takanawa Clinic
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	Research Ethics Committee of Takanawa Clinic
Address	1-22-17, Kitashinagawa, Shinagawa-ku, Tokyo
Tel	03-6712-9747
Email	support@idou-medical.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	高輪クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 09 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	18
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	2020 Year 04 Month 20 Day
Date of IRB	2020 Year 05 Month 07 Day
Anticipated trial start date	2020 Year 05 Month 09 Day
Last follow-up date	2020 Year 05 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 08 Day
Last modified on	2021 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046023