Japanease

Aug. 26, 2020

Mar. 25, 2021

jRCTs051200049

Multicenter Study to evaluate efficacy and safety of Demethylchlortetracycline in Patients of COVID-19 (COVID-DMC)

Therapeutic drug development program for COVID-19 (COVID-DMC)

Iwahori Kota

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka, Japan

+81-6-6879-8413

iwahori@climm.med.osaka-u.ac.jp

Baden Megu

Department of Medical Innovation, Osaka University Hospital

2-2, Yamadaoka, Suitashi, Osaka, Japan

+81-6-6210-8289

mbaden@endmet.med.osaka-u.ac.jp

Nov. 02, 2020

30

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

none

1) Patients who are positive for SARS-CoV-2 by PCR or antigen test
2) Patients who are diagnosed with pneumonia by Chest X-ray or CT
3) Patients who do not need continuous (24h) oxygen inhalation
4) Patients who can eat and drink
5) Patients older or equal to 20 years old and younger than 75 years old
6) Patients who can sign the informed consent form by themselves

1) Patients with hypersensitivity for tetracycline compound
2) Patients showing SpO2 < 93% without oxygen inhalation
3) Patients who are or have a possibility to be pregnant, or hope to be pregnant during the study.
4) Patients with liver failure (AST and/or ALT >= the standard value)
5) Patients with kidney failure (eGFR < 30 ml/min/1.73m2)
6) Patients who are considered unsuitable for the study by the PI or sub investigators

20age old over
75age old not

Both

COVID-19 pneumonia

Patients will be randomized to the following 3 groups.
1) Group with 150mg/day
In addition to ordinary drug therapyies the study drug 150 mg/day will be administered to patients for 14 days.
2) Group with 300mg/day
In addition to ordinary drug therapyies, the study drug 300 mg/day (150mg for one dose, 2 times per day) will be administered to patients for 14 days.
3) Control group
Patients will receive only ordinary drug therapies as doctoters indicated.

BAT: best available therapy

The change rate of CD8+ T cells between before and 7 days after the administration of the study drug

1) Duration between the start day of study drug administration and the time when patients need continuous (24h) oxygen therapy
2) The change and change rate of SpO2
3) The change of CD8+ T cells between before and 7 days after the administration of the study drug
4) The change of Peripheral blood T cell activity (PeriCyto) between before and 7 days after the administration of the study drug
5) The change rate of Peripheral blood T cell activity (PeriCyto) between before and 7 days after the administration of the study drug
6) Negative conversion rate of COVID-19
7) The change rate of COVID-19 viral quantity measured by quantitative PCR
8) The change rate of IL-6, IFN-gamma, TNF-alpha
9) The change rate of CD4, CD19
10) The improvement rate of NEWS score
11) The change of clinical status measured by 7 degrees of ordinal scale score
12) The change of clinical symptoms (e.g. cough, dyspnea) self-reported by patients

Recruiting

SHIONOGI & CO., LTD.
Not applicable
Osaka University Hospital
Not applicable
Osaka University Clinical Research Review Committee
2-2 Yamadaoka, Suitashi, Osaka, Japan, Osaka

+81-6-6210-8296

handai-nintei@hp-crc.med.osaka-u.ac.jp
Approval

Aug. 17, 2020