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NCT Number: NCT04657497

A Study of FOY-305 in Patients With 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.

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Key information

Conditions

SARS-CoV-2 Infection (COVID-19) COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aichi Clinical Site 1, Tokoname, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Receiving oxygen therapy
  • Difficulty in swallowing oral medication
  • History of COVID-19
  • History of vaccination against COVID-19
  • Taking camostat mesilate

Treatment and study plan

FOY-305

Drug

Specified Dosage and Duration of Treatment

Placebo

Drug

Specified Dosage and Duration of Treatment

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to SARS-CoV-2 negative test

    Time frame: Up to 14 days

    Time to SARS-CoV-2 negative test as assessed by the central laboratory

  2. Proportion of subjects who test negative for SARS-CoV-2

    Time frame: Up to 14 days

    Proportion of subjects who test negative for SARS-CoV-2 (as assessed by the local and central laboratories)

  3. Ordinal scale for severity

    Time frame: Up to 14 days

    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.

  4. Proportion of subjects on mechanical ventilator

    Time frame: Up to 14 days

    Proportion of subjects on mechanical ventilator

  5. Survival status (alive/death)

    Time frame: Up to 14 days

    Proportion of subjects alive or death

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Placebo-controlled, Multicenter, Double-blind, Randomized, Parallel-group Comparative Study in SARS-CoV-2 Infection (COVID-19)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2020
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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