Clinical trial NCT04657497: A Study of FOY-305 in Patients With SARS-Cov-2 Infection (COVID-19)
Official title: A Placebo-controlled, Multicenter, Double-blind, Randomized, Parallel-group Comparative Study in SARS-CoV-2 Infection (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2 Infection (COVID-19)
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2020-12-08
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of FOY-305 in patients with SARS-CoV-2 infection (COVID-19) in a placebo-controlled, multicenter, double-blind, randomized, parallel-group comparative study.


Eligibility criteria: Inclusion Criteria:

1. Inpatient or outpatient: Inpatient
2. Positive SARS-CoV-2 test by a method eligible for definitive diagnosis
3. Enrollment in this study within 5 days after onset of symptoms of SARS-CoV-2 infection (COVID-19) (for asymptomatic patients, enrollment in this study within 5 days after collection of the sample that tested positive)

Exclusion Criteria:

1. Receiving oxygen therapy
2. Difficulty in swallowing oral medication
3. History of COVID-19
4. History of vaccination against COVID-19
5. Taking camostat mesilate

Primary outcomes:
measure: Time to SARS-CoV-2 negative test
timeFrame: Up to 14 days
Secondary outcomes:
measure: Time to SARS-CoV-2 negative test
timeFrame: Up to 14 days
measure: Proportion of subjects who test negative for SARS-CoV-2
timeFrame: Up to 14 days
measure: Ordinal scale for severity
timeFrame: Up to 14 days
measure: Proportion of subjects on mechanical ventilator
timeFrame: Up to 14 days
measure: Survival status (alive/death)
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Tokoname
country: Japan
facility: Aichi Clinical Site 1
state: Aichi
city: Narita
country: Japan
facility: Chiba Clinical Site 1
state: Chiba
city: Okawa
country: Japan
facility: Fukuoka Clinical Site 1
state: Fukuoka
city: Tsuchiura
country: Japan
facility: Ibaraki Clinical Site 1
state: Ibaraki
city: Kanazawa
country: Japan
facility: Ishikawa Clinical Site 1
state: Ishikawa
city: Kawasaki
country: Japan
facility: Kanagawa Clinical Site 3
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Clinical Site 1
state: Kanagawa
city: Yokosuka
country: Japan
facility: Kanagawa Clinical Site 2
state: Kanagawa
city: Yokkaichi
country: Japan
facility: Mie Clinical Site 1
state: Mie
city: Nagaoka
country: Japan
facility: Niigata Clinical Site 1
state: Niigata
city: Daito
country: Japan
facility: Osaka Clinical Site 2
state: Osaka
city: Kawagoe
country: Japan
facility: Saitama Clinical Site 3
state: Saitama
city: Kuki
country: Japan
facility: Saitama Clinical Site 1
state: Saitama
city: Kumagaya
country: Japan
facility: Saitama Clinical Site 2
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Tokyo Clinical Site 5
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Clinical Site 9
state: Tokyo
city: Hachioji
country: Japan
facility: Tokyo Clinical Site1
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Tokyo Clinical Site 7
state: Tokyo
city: Meguro-ku
country: Japan
facility: Tokyo Clinical Site 3
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Tokyo Clinical Site 4
state: Tokyo
city: Sibuya-ku
country: Japan
facility: Tokyo Clinical Site 8
state: Tokyo
city: Sibuya-ku
country: Japan
facility: Tokyo Clinical Site2
state: Tokyo
city: Tachikawa
country: Japan
facility: Tokyo Clinical Site 6
state: Tokyo
city: Okayama
country: Japan
facility: Okayama Clinical Site 1
city: Osaka
country: Japan
facility: Osaka Clinical Site 1
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Naoyuki Komura
role: STUDY_DIRECTOR
References:
citation: Kinoshita T, Shinoda M, Nishizaki Y, Shiraki K, Hirai Y, Kichikawa Y, Tsushima K, Shinkai M, Komura N, Yoshida K, Kido Y, Kakeya H, Uemura N, Kadota J. A multicenter, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of camostat mesilate in patients with COVID-19 (CANDLE study). BMC Med. 2022 Sep 27;20(1):342. doi: 10.1186/s12916-022-02518-7.