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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200196
Enrollment
118
Registered
2020-11-11
Start date
2020-11-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Disease 2019 (COVID-19) COVID-19

Interventions

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

Sponsors

Tsushima Kenji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Length of hospital stay

Secondary

MeasureTime frame
(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

Contacts

Public ContactJiro Terada

International University of Health and Welfare, Narita Hospital

jirotera@iuhw.ac.jp+81-476-35-5600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026