Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04649515
Status:
TERMINATED
Last Update Posted:
2022-03-24
First Post:
2020-11-26
Brief Title:
Efficacy and Safety of TY027 a Treatment for COVID-19 in Humans
Sponsor:
Tychan Pte Ltd
Organization:
Tychan Pte Ltd
Study Overview
Official Title:
Phase 3 Multi-Site Randomised Placebo Controlled Double Blind Single Dose Study of TY027 for Early Treatment of COVID-19
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The emergence rapid spread of the coronavirus disease 2019 COVID-19 since December 2019 across 188 countries globally has become a major public health crisis COVID-19 was declared a pandemic by the World Health Organisation on 11 March 2020 To date tens of millions of cases have been reported and over 3 of these cases have died COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus just like SARS-CoV and MERS-CoV SARS-CoV-2 is primarily transmitted person-to-person through respiratory dropletsclose contact Fomite transmission has also been shown as a transmission route Common respiratory symptoms such as fever sore throat cough shortness of breath may appear 2 - 14 days after exposure About 20 of infected cases progress to severe disease resulting in an estimated 2 - 5 mortality rate With the unrelenting increase in cases being reported worldwide there is thus an urgent need for therapeutics to be developed to treat disease reduce further transmission in order to disrupt the ongoing pandemic
To date there are no specific proven antiviral treatment to prevent disease progression from mild to severe respiratory dysfunction among COVID-19 patients Supportive care is recommended for symptom relief for severe cases Numerous vaccine candidates against SARS-CoV-2 are under development Tychans TY027 a fully engineered human IgG is one of the first few biologics in the world specifically targeting SARS-CoV-2 to enter human clinical trials Preliminary data from our phase 1 healthy volunteer trial SCT-001 ClinicalTrialsgov Identifier NCT04429529 reveals that TY027 is safe well-tolerated up to 20 mgkg tested A total of 10 adverse events AEs were observed all were of mild in intensity with none resulting in subject withdrawal from the study There were no serious adverse events no clinically relevant trends in mean clinical laboratory physical examinations vital signs or ECG results were observed Pharmacokinetic profile of subjects across dose cohorts 1 - 4 up to Day 14 were comparable to those typical of human IgG1 antibody with serum concentrations declining in a biphasic manner Exposure of TY027 based on Cmax increased in a linear generally dose proportional manner It is anticipated that TY027 when administered to acutely infected COVID-19 patients could reduce disease severity It may potentially also be used as a prophylaxis against COVID-19 amongst high risk contacts
To date there are no specific proven antiviral treatment to prevent disease progression from mild to severe respiratory dysfunction among COVID-19 patients Supportive care is recommended for symptom relief for severe cases Numerous vaccine candidates against SARS-CoV-2 are under development Tychans TY027 a fully engineered human IgG is one of the first few biologics in the world specifically targeting SARS-CoV-2 to enter human clinical trials Preliminary data from our phase 1 healthy volunteer trial SCT-001 ClinicalTrialsgov Identifier NCT04429529 reveals that TY027 is safe well-tolerated up to 20 mgkg tested A total of 10 adverse events AEs were observed all were of mild in intensity with none resulting in subject withdrawal from the study There were no serious adverse events no clinically relevant trends in mean clinical laboratory physical examinations vital signs or ECG results were observed Pharmacokinetic profile of subjects across dose cohorts 1 - 4 up to Day 14 were comparable to those typical of human IgG1 antibody with serum concentrations declining in a biphasic manner Exposure of TY027 based on Cmax increased in a linear generally dose proportional manner It is anticipated that TY027 when administered to acutely infected COVID-19 patients could reduce disease severity It may potentially also be used as a prophylaxis against COVID-19 amongst high risk contacts
Detailed Description:
This is a Phase 3 Multi-Site Randomised Placebo Controlled Double Blind Single Dose Study of TY027 for Early Treatment of COVID-19
Efficacy and safety of single dose IV infusion of TY027 in COVID-19 patients will be assessed
A total of 1305 COVID-19 patients will be enrolled The first 15 patients will be randomised 111 to receive either i a single fixed dose of 1500 mg TY027 ii a single fixed dose of 2000 mg TY027 or iii Placebo N 5 per group for initial safety assessment This safety assessment will comprise the safety review of clinical signs adverse events AEs and laboratory test results up to Day 3 post-dose
Subsequent patients will be randomised 11 to receive either a single fixed dose of 2000 mg TY027 2000 mg TY027 group or Placebo Placebo group N 645 per group
All patients will be inpatient for up to 7 days post-dosing and followed up on Days 14 and 28
If a patient becomes clinically well enough for discharge before Day 7 at the discretion of attending physician collection of subsequent eventsparameters such as abbreviated physical examinations vital signs clinical laboratory assessments pharmacodynamic assessment biomarker assessment disseminated intravascular coagulation assessment scheduled after discharge will no longer be feasbile Conversely if a patient was to be hospitalised beyond 7 days for medically indicated reasons daily monitoring and medical assessment will continue with any additional ad hoc sampling to be recorded as unscheduled visits
Remote monitoring through a telephone or video call will be performed on days post-discharge as per originally scheduled in schedule of events as well as on Day 14 while patients are serving their quarantine order or has been discharged home
All discharged patients are to contact the Principal Investigator or the study team as soon as possible should they experience a worsening of their condition or if they are admitted to hospital for COVID-19-related symptoms before their Day 28 visit
Final safety and efficacy analysis of all patients will be assessed at the end of the study
Efficacy and safety of single dose IV infusion of TY027 in COVID-19 patients will be assessed
A total of 1305 COVID-19 patients will be enrolled The first 15 patients will be randomised 111 to receive either i a single fixed dose of 1500 mg TY027 ii a single fixed dose of 2000 mg TY027 or iii Placebo N 5 per group for initial safety assessment This safety assessment will comprise the safety review of clinical signs adverse events AEs and laboratory test results up to Day 3 post-dose
Subsequent patients will be randomised 11 to receive either a single fixed dose of 2000 mg TY027 2000 mg TY027 group or Placebo Placebo group N 645 per group
All patients will be inpatient for up to 7 days post-dosing and followed up on Days 14 and 28
If a patient becomes clinically well enough for discharge before Day 7 at the discretion of attending physician collection of subsequent eventsparameters such as abbreviated physical examinations vital signs clinical laboratory assessments pharmacodynamic assessment biomarker assessment disseminated intravascular coagulation assessment scheduled after discharge will no longer be feasbile Conversely if a patient was to be hospitalised beyond 7 days for medically indicated reasons daily monitoring and medical assessment will continue with any additional ad hoc sampling to be recorded as unscheduled visits
Remote monitoring through a telephone or video call will be performed on days post-discharge as per originally scheduled in schedule of events as well as on Day 14 while patients are serving their quarantine order or has been discharged home
All discharged patients are to contact the Principal Investigator or the study team as soon as possible should they experience a worsening of their condition or if they are admitted to hospital for COVID-19-related symptoms before their Day 28 visit
Final safety and efficacy analysis of all patients will be assessed at the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None