SARS-CoV-2 Infection (COVID-19)Phase 3NCT04657497
A Study of FOY-305 in Patients With SARS-Cov-2 Infection (COVID-19)
A Phase 3 study testing FOY-305 in people with SARS-CoV-2 Infection (COVID-19), run by Ono Pharmaceutical Co., Ltd. at 25 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection (COVID-19)
- What is being tested?
- FOY-305
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 25 sitesJapan
- Study dates
- 9 Nov 2020to 9 Apr 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient or outpatient: Inpatient
- Positive SARS-CoV-2 test by a method eligible for definitive diagnosis
- 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)
Who cannot join
- Receiving oxygen therapy
- Difficulty in swallowing oral medication
- History of COVID-19
- History of vaccination against COVID-19
- Taking camostat mesilate
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Tokyo Clinical Site 5
Bunkyo-ku, Tokyo
Tokyo Clinical Site 9
Bunkyo-ku, Tokyo
Osaka Clinical Site 2
Daitō, Osaka
Tokyo Clinical Site1
Hachiōji, Tokyo
Ishikawa Clinical Site 1
Kanazawa, Ishikawa-ken
Saitama Clinical Site 3
Kawagoe, Saitama
Kanagawa Clinical Site 3
Kawasaki, Kanagawa
Saitama Clinical Site 1
Kukichūō, Saitama
Saitama Clinical Site 2
Kumagaya, Saitama
Tokyo Clinical Site 3
Meguro-ku, Tokyo
Niigata Clinical Site 1
Nagaoka, Niigata
Chiba Clinical Site 1
Narita, Chiba
Fukuoka Clinical Site 1
Ōkawa, Fukuoka
Okayama Clinical Site 1
Okayama
Osaka Clinical Site 1
Osaka
Tokyo Clinical Site 4
Shinagawa-ku, Tokyo
Tokyo Clinical Site 8
Sibuya-ku, Tokyo
Tokyo Clinical Site2
Sibuya-ku, Tokyo
Tokyo Clinical Site 7
tabashi City, Tokyo
Tokyo Clinical Site 6
Tachikawa, Tokyo
Aichi Clinical Site 1
Tokoname, Aichi-ken
Ibaraki Clinical Site 1
Tsuchiura, Ibaraki
Mie Clinical Site 1
Yokkaichi, Mie-ken
Kanagawa Clinical Site 1
Yokohama, Kanagawa
Kanagawa Clinical Site 2
Yokosuka, Kanagawa
About this study
Official title: A Placebo-controlled, Multicenter, Double-blind, Randomized, Parallel-group Comparative Study in SARS-CoV-2 Infection (COVID-19)
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.
- Conditions
- SARS-CoV-2 Infection (COVID-19)
- Being tested
- FOY-305, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOY-305Drug
Specified Dosage and Duration of Treatment
PlaceboDrug
Specified Dosage and Duration of Treatment
| Study group | Role | What they receive |
|---|---|---|
| FOY-305 group | Experimental | Camostat Mesilate tablets 600 mg will be orally administered 4 times daily, before breakfast, before lunch, before evening meal, and at bedtime. The treatment period is up to 14 days. Receives: Drug: FOY-305 |
| Placebo group | Placebo comparator | Placebo tablets will be orally administered 4 times daily, before breakfast, before lunch, before evening meal, and at bedtime. The treatment period is up to 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to SARS-CoV-2 negative test
Time to SARS-CoV-2 negative test as assessed by the local laboratory
Measured: Up to 14 days
Secondary outcomes (5)
Time to SARS-CoV-2 negative test
Time to SARS-CoV-2 negative test as assessed by the central laboratory
Measured: Up to 14 days
Proportion of subjects who test negative for SARS-CoV-2
Proportion of subjects who test negative for SARS-CoV-2 (as assessed by the local and central laboratories)
Measured: Up to 14 days
Ordinal scale for severity
Ordinal scale for severity. The minimum score is 0: No clinical or virological evidence of infection, representing the better outcome, and the maximum value is 8: Death, representing the worse outcome.
Measured: Up to 14 days
Proportion of subjects on mechanical ventilator
Proportion of subjects on mechanical ventilator
Measured: Up to 14 days
Survival status (alive/death)
Proportion of subjects alive or death
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start9 Nov 2020
- Primary completion26 Mar 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 Infection (COVID-19)Studies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naoyuki Komura, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657497
- Sponsor's protocol ID
- FOY-305-01
- Status last verified
- Apr 2024
- First submitted
- 9 Nov 2020
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shapira S, Vishnevsky G, Yaakobi H, Shenberg G, Motlaq M, Liberman E, Kalisky A, Benari G, Tsiodras S, Adi N, Lotvall J, Arber N. Reduced Mortality in COVID-19 Patients Treated With Inhaled Extracellular Vesicles Expressing CD24. J Extracell Vesicles. 2026 Mar;15(3):e70253. doi: 10.1002/jev2.70253.
PubMed 41823222Kinoshita 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.
PubMed 36163020
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Multicenter, Double-blind, Randomized, Parallel-group Comparative Study in SARS-CoV-2 Infection (COVID-19)
- ClinicalTrials.gov ID
- NCT04657497
- Acronym / sponsor ID
- FOY-305-01
- Conditions
- SARS-CoV-2 Infection (COVID-19)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOY-305 group | Experimental | Drug: FOY-305Camostat Mesilate tablets 600 mg will be orally administered 4 times daily, before breakfast, before lunch, before evening meal, and at bedtime. The treatment period is up to 14 days. |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo tablets will be orally administered 4 times daily, before breakfast, before lunch, before evening meal, and at bedtime. The treatment period is up to 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inpatient or outpatient: Inpatient
- Positive SARS-CoV-2 test by a method eligible for definitive diagnosis
- 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)
Key exclusion criteria (5 listed)
- Receiving oxygen therapy
- Difficulty in swallowing oral medication
- History of COVID-19
- History of vaccination against COVID-19
- Taking camostat mesilate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOY-305Specified Dosage and Duration of Treatment | Drug | FOY-305 group |
| PlaceboSpecified Dosage and Duration of Treatment | Drug | Placebo group |
Primary outcome
Time to SARS-CoV-2 negative test
Time frame: Up to 14 days
Time to SARS-CoV-2 negative test as assessed by the local laboratory
5 secondary outcomes
Time to SARS-CoV-2 negative test
Time frame: Up to 14 days
Proportion of subjects who test negative for SARS-CoV-2
Time frame: Up to 14 days
Ordinal scale for severity
Time frame: Up to 14 days
Proportion of subjects on mechanical ventilator
Time frame: Up to 14 days
Survival status (alive/death)
Time frame: Up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Derived from this study: PubMed 41823222Shapira S, Vishnevsky G, Yaakobi H, Shenberg G, Motlaq M, Liberman E, Kalisky A, Benari G, Tsiodras S, Adi N, Lotvall J, Arber N. Reduced Mortality in COVID-19 Patients Treated With Inhaled Extracellular Vesicles Expressing CD24. J Extracell Vesicles. 2026 Mar;15(3):e70253. doi: 10.1002/jev2.70253.
- Derived from this study: PubMed 36163020Kinoshita 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naoyuki Komura study director
Ono Pharmaceutical Co., Ltd.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FOY-305 in people with SARS-CoV-2 Infection (COVID-19), run by Ono Pharmaceutical Co., Ltd. at 25 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to SARS-CoV-2 negative test (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04657497, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.