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

Phase 2

• Conditions: Coronavirus Disease 2019 (COVID-19); COVID-19

• Registration Number: JPRN-jRCTs031200196
• Lead Sponsor: Tsushima Kenji

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-11
• Study Completion: 2021-05-03
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 118

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified