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Column | Value |
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Trial registration number | JPRN-jRCT2031210350 |
Full text link
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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First author
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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Contact
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
shionogiclintrials-admin@shionogi.co.jp |
Registration date
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2021-09-28 |
Recruitment status
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Recruiting |
Study design
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
RCT |
Allocation
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Randomized |
Design
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Parallel |
Masking
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Blind label |
Center
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
unclear |
Study aim
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Treatment |
Inclusion criteria
Last imported at : March 4, 2022, 2 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
For mild/moderate SARS-CoV-2-infected participants:- Participants who were diagnosed as SARS-CoV-2 positive within 120 hours before randomization.- Participants with time from COVID-19 onset to randomization of =< 120 hours.- Participants who have at least one moderate or severe symptom among the following 12 symptoms of COVID-19 at the time of randomization.(low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, stuffy or runny nose, sore throat, cough, shortness of breath, nausea, vomiting, diarrhea)For asymptomatic SARS-CoV-2-infected participants (Phase 2a Part):- Participants who were diagnosed as SARS-CoV-2 positive within 120 hours before randomizationt.- Participants who have none of the following 14 symptoms of COVID-19 within 2 weeks before randomization.(low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, taste disorder, smell disorder, stuffy or runny nose, sore throat, cough, shortness of breath, nausea, vomiting, diarrhea)For asymptomatic/only mild symptoms SARS-CoV-2-infected participants (Phase 2b/3 Part):- Participants who were diagnosed as SARS-CoV-2 positive within 120 hours before randomizationt.- Participants who do not have any symtoms of moderate or severe symptom among the 12 symptoms of COVID-19 at the time of randomization. |
Exclusion criteria
Last imported at : March 4, 2022, 2 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Common for Phase 2a Part and Phase 2b/3 PartAnd commmon for mild/moderate and asumptomatic SARS-CoV-2-infected participants- Participants with a percutaneous oxygen saturation (SpO2) during wakefulness of =< 93% (room air)- Participants strongly suspected to have pneumonia- Participants who need oxygen administration- Participants who need a mechanical ventilation - Participants who are strongly suspected to have worsening of symptoms of SARS-CoV-2 infection within 48 hours after randomization, in the opinion of the investigator/subinvestigator- Participants with suspected active and systemic infections requiring treatment at the time of randomization (excluding SARS-CoV-2)- Current or chronic history of moderate or severe liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)- Current or chronic history of moderate or severe kidney disease- Participants who have used any of the following drugs within 7 days prior to randomization(approved/unapproved drugs for the treatment of SARS-CoV-2 infection, antiviral, antibacterial, or antifungal drugs [excluding topical use])- Participants who have used any of the following drugs within 14 days prior to randomization(strong CYP 3A inhibitor, strong CYP 3A inducer, products containing St. John's wort) |
Number of arms
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2 |
Funding
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Nagata Tsutae |
Inclusion age min
Last imported at : Dec. 30, 2021, 7:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
12 |
Inclusion age max
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
70 |
Countries
Last imported at : March 4, 2022, 2 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Democratic People's Republic of Korea;Japan |
Type of patients
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Mild/moderate disease at enrollment |
Severity scale
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2: Mild/moderate disease at enrollment |
Total sample size
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2949 |
primary outcome
Last imported at : May 5, 2022, 11:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Phase 2a PartChange from baseline in SARS-CoV-2 viral titer at each time pointPhase 2b PartTime-weighted average change in total score of 12 COVID-19 symptoms from Day 1 up to Day 6Change from baseline on Day 4 in SARS CoV-2 viral titerPhase 3 PartTime to resolution of COVID-19 symptomsTime to the first negative SARS CoV-2 viral titerPhase 2b/3 PartFor asymptomatic/only mild symptom SARS-CoV-2-infected participants:Proportion of participants with occurrence/worsening of COVID-19 symptomsTime to first confirmation of negative SARS CoV-2 viral titer |
Notes
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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Phase
Last imported at : Nov. 13, 2021, 5:33 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Phase 2/Phase 3 |
Arms
Last imported at : Oct. 21, 2021, 10 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
[{"arm_notes": "", "treatment_id": 1812, "treatment_name": "S-217622", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |