臨床研究等提出・公開システム

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

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

Tanaka Yukio

Department of Medical Innovation, Osaka University Hospital

2-2, Yamadaoka, Suitashi, Osaka, Japan

+81-6-6210-8289

yukiotanaka@dmi.med.osaka-u.ac.jp

Not Recruiting

Sept. 01, 2020

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Patients who are positive for SARS-CoV-2 by PCR or antigen test
2) Patients who do not need continuous (24h) oxygen inhalation
3) Patients who can eat and drink
4) Patients older or equal to 20 years old and younger than 75 years old
5) 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 had a COVID-19 vaccination
7) Patients who are considered unsuitable for the study by the PI or sub investigators

Both

COVID-19

Patients will be randomized to the following 3 groups.
1) Group with 150mg/day
In addition to ordinary therapyies for COVID-19, the study drug 150 mg/day will be administered to patients for 14 days.
2) Group with 300mg/day
In addition to ordinary therapyies for COVID-19, 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 therapies for COVID-19 as doctors indicated.

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) Negative conversion rate of COVID-19
5) The change rate of COVID-19 viral quantity measured by quantitative PCR
6) The change rate of IL-6, IFN-gamma, TNF-alpha
7) The change rate of CD4, CD19
8) The improvement rate of NEWS score
9) The change of clinical status measured by 7 degrees of ordinal scale score
10) The change of clinical symptoms (e.g. cough, dyspnea) self-reported by patients

+81-6-6210-8296

Feb. 02, 2002

No

none