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A multicenter, randomized controlled trial to evaluate the effect of favipiravir, camostat mesilate and inhaled ciclesonide for COVID-19 pneumonia

Combination therapy of favipiravir, camostat mesilate and inhaled ciclesonide for COVID-19 pneumonia

118

Total 118 patients were enrolled; 1 refused to participate in this study before starting the therapy Group; Mono therapy (n=56), Combination therapy (n=61) Age (years), 57.2, 59.5 Sex (male), 37, 39 BMI, 25.7, 26.0

The study enrollement was started from November 11th 2020. 118 patients underwent randomization based on the study design. Except for one patients (refused to pacticipate in this study before starting the therapy), all schedulled 117 patients were enrolled before the time of April 5th 2021 (mono therapy group 56; combination therapy group, 61). On May 3th 2021, the observation period of the final patient was completed.

All adverse event was 42/56 (57.1%) in mono therapy group and 39/61 (55.7%); no difference was observed between two group. Main adverse event was hyperuricemia 28/56 (50%) in mono therapy group and 30/61 (49.2%) . Serious advrse event acute pulmonary embolism was observed in 1 patients with mono therapy group; however no causal relationship between monotherapy and the event was found. Other serious adverse events were not observed in both groups.

The primary outcome, the length of hospital stay due to COVID-19 pneumonia (median, 95%CI) was 11 day in monotherapy group and 10 day in the combination therapy group (P=0.025). The parameters of secondary outcome between two groups were not statistically different. The tendency of the high proportion of discharge with full recovery at day 8 in the combination therapy group compared to the mono therapy group.

Based on the clinical trail planning, 117 eligible participants were randomly assigned to receive either monotherapy (favipiravir n=56) or combination therapy (favipiravir + camostat + ciclesonide, n=61). The primary outcome, the length of hospital stay due to COVID-19 pneumonia (median, 95%CI) was 11 day in monotherapy group and 10 day in the combination therapy group (P=0.025). Regarding adverse events, no difference was observed between two groups.

Feb. 15, 2022

Yes

The clinical data obtained in this study will be secondarily used after the report of the study is completed (in the condition that data anonymization and privacy issues are protected). Especially, the comparison in effect between the newly approved drugs in Japan (eg., Remdesivir, Baricitinib) vs. mono therapy or combination therapy in this study will be retrospectively conducted.

https://jrct.niph.go.jp/latest-detail/jRCTs031200196

Tsushima Kenji

International University of Health and Welfare, Narita Hospital

852 Hatakeda, Narita, Chiba

ktsushima@iuhw.ac.jp

Terada Jiro

International University of Health and Welfare, Narita Hospital

852 Hatakeda, Narita, Chiba

+81-476-35-5600

jirotera@iuhw.ac.jp

Complete

Nov. 11, 2020

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Patients who have given written consent to participate in the study
2) age > 20 years old
3) SARS-CoV-2 PCR or LAMP test positive or COVID-19 confirmed by the diagnostic test which is approved by the Ministry of Health, Labor and Welfare
4) Patients with COVID-19 pneumonia on chest CT scan
5) Patients who can admit on the hospital at least 10 days during treatment
6) Patients who can use ciclesonide inhaler
7) Pregnancy test-negative

1) Patients who had been already treated with ceratain drug for COVID-19
2) Patients diagnosed with relapse or 2nd infection of COVID-19
3) Patiens with obvious other respiratory infection
4) Patients having cardiac dysfunctions such as congestive heart failure
5) Patients having severe liver dysfunction such as Child-Pugh C state
6) Patients having renal dysfunction requiring dialysis
7) Patients having immuno deficiency such as HIV infection
8) Patients having disorders of consciousness such as disorientation
9) Patients using the drug of immuno suppression
10) Patients using steroid inhaler
11) Patients who are pregnant or who may be pregnant
12) Patients who cannot use contraceptive
13) Male patients having a partner who agree with the usage of contraceptive
14) Patients with hereditary xanthineuria
15) Patients with Patients with hypouricemia or xanthine urinary stone
16) Patients with retractable gout or hyperuricemia
17) Patents with allergy of favipiravir, camostat mesilate or inhaled ciclesonide
18) Patients in severe disease state with artificial ventilation, or ECMO in intensive care unit
19) Patients who are considered inappropriate for inclusion in the study by the investigator

Both

Coronavirus Disease 2019 (COVID-19)

10 day treatment with the combination usage of favipiravir, camostat mesilate and inhaled ciclesonide

COVID-19

Length of hospital stay

(1) clinical course: fever, oxygen demand, respiratory rate, SpO2, usage of artificial ventilation or ECMO, stay in ICU, usage of other drugs
(2) change of laboratory findings: Alb, lymphocyte, CRP, D-dimer, PIC, TAT, white blood cells, platelet, bil, AST, ALT, LDH, ALP, CK, cre, BUN, Na, K, Glu, uric acid, PCT, , Ferritin, IL-6
(3) SARS-COV2 viral load
(4) SARS-CO2 antibody

+81-3-5803-4575

Oct. 20, 2020

none