Coronavirus Disease-2019 (COVID-19)Phase 3NCT04649515
Efficacy and Safety of TY027, a Treatment for COVID-19, in Humans
A Phase 3 study testing TY027 and 0.9% saline in people with Coronavirus Disease-2019 (COVID-19), run by Tychan Pte Ltd. at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Coronavirus Disease-2019 (COVID-19)
- What is being tested?
- TY027 and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSingapore
- Study dates
- 4 Dec 2020to 4 Mar 2022
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic and RT-PCR confirmed COVID-19 within 6 days from symptom onset.
- Has any one of the following factors associated with disease progression:
- Elevated lactate dehydrogenase (LDH)
- Elevated C reactive protein (CRP)
- Lymphocyte count below normal limit
- Age 40 and above
Show all 12Show fewer
- History of well-controlled diabetes, hypertension, chronic obstructive lung disease or ischemic heart diseases
- Stable chronic renal disease
- History of asthma
- Disease outcome score of 6, 7 or 8 based on the COVID Scale
- Willing to comply with the requirements of the study protocol and attend scheduled study visits
- Can give written informed consent approved by the Ethical Review Board governing the site
Who cannot join
- Aged below 21 years old
- Female who is pregnant or breast-feeding
- With the following conditions, but not limited to:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy defined as prednisone or equivalent for more than 2 consecutive weeks within the past 3 months
- Child-Pugh Class C chronic liver disease
- Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 calculated by the CKD-EPI formula
Show all 11Show fewer
- Suspected or confirmed active bacterial, fungal or mycobacterial infection
- History of any allergic reaction to monoclonal antibodies
- Currently enrolled in another COVID-19 investigational drug study
- Previously enrolled in a COVID-19 investigational vaccine study
- Any medical condition, which in the opinion of the Investigator, will compromise the safety of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Multi-Site, Randomised, Placebo Controlled, Double Blind, Single Dose Study of TY027 for Early Treatment of COVID-19
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 droplets/close 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. Tychan's 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; ClinicalTrials.gov Identifier NCT04429529) reveals that TY027 is safe \& well-tolerated up to 20 mg/kg 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.
Read the 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 1,305 COVID-19 patients will be enrolled. The first 15 patients will be randomised 1:1:1 to receive either (i) a single fixed dose of 1,500 mg TY027, (ii) a single fixed dose of 2,000 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 1:1 to receive either a single fixed dose of 2,000 mg TY027 (2,000 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 events/parameters 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 visit(s).
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.
- Conditions
- Coronavirus Disease-2019 (COVID-19)
- Being tested
- TY027, 0.9% saline
- Keywords
- Coronavirus Disease-2019, COVID-19, SARS-CoV-2, Monoclonal Antibody, Infectious diseases, Phase 3 study, Singapore
- Medical subject headings
- COVID-19, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TY027Biological
TY027 Injection, (100 mg/5 mL/Vial), SARS-CoV-2 Monoclonal Antibody (mAb) - 1,500 mg of TY027
TY027Biological
TY027 Injection, (100 mg/5 mL/Vial), SARS-CoV-2 Monoclonal Antibody (mAb) - 2,000 mg of TY027
0.9% salineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TY027 1,500 mg | Experimental | 1,500 mg of TY027 will be administered via IV infusion over a period of 30 minutes. Receives: Biological: TY027 |
| TY027 2,000 mg | Experimental | 2,000 mg of TY027 will be administered via IV infusion over a period of 30 minutes. Receives: Biological: TY027 |
| Placebo | Placebo comparator | Placebo will be administered via IV infusion over a period of 30 minutes. Receives: Other: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of a single dose intravenous (IV) infusion of TY027 in reducing disease progression, defined as progression to score 4 and below on COVID scale
Proportion of COVID-19 patients with disease progression, defined as progression to score 4 and below on the COVID Scale, within the first 14 days after a single dose IV infusion of TY027 as compared to placebo
Measured: Within the first 14 days
Secondary outcomes (6)
Rate of AEs (grade 3 and above) and SAEs in COVID-19 patients
Rate of AEs (grade 3 and above) and SAEs in COVID-19 patients after a single dose IV infusion of TY027 as compared to placebo
Measured: 28 days
All cause mortality rate
All cause mortality rate by Day 28 in COVID-19 patients who receive a single dose IV infusion of TY027 as compared to placebo
Measured: 28 days
Proportion of subjects in categories 4, 3, 2 and 1 of the COVID scale
Proportion of subjects in categories 4, 3, 2 and 1 of the COVID scale at Day 7, Day 14 and Day 28
Measured: Up to Day 28
Number of days COVID-19 patients require supplemental oxygen, high flow oxygen, non-invasive and invasive mechanical ventilation (if applicable)
Number of days COVID-19 patients require supplemental oxygen, high flow oxygen, non-invasive and invasive mechanical ventilation (if applicable) after a single dose IV infusion of TY027 as compared to placebo up to Day 28
Measured: 28 days
Proportion of COVID-19 patients tested negative for SARS-CoV-2 via reverse transcriptase-polymerase chain reaction (RT-PCR)
Proportion of COVID-19 patients tested negative for SARS-CoV-2 via reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 3, Day 5, Day 7, Day 14 and Day 28 after a single dose IV infusion of TY027 as compared to placebo
Measured: Up to Day 28
Proportion of COVID-19 patients with a minimum of 0.5 log time-weighted viral load reduction from saliva samples, via sub-genomic qRT-PCR
Proportion of COVID-19 patients with a minimum of 0.5 log time-weighted viral load reduction from saliva samples, via sub-genomic qRT-PCR, at Day 7 post-dose or day of discharge, whichever is earlier, as compared to baseline between study groups
Measured: Day 7 post-dose or day of discharge, whichever is earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start4 Dec 2020
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease-2019 (COVID-19)Studies of the same condition, open and under way.
- 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
- Model description
- Participants are assigned to either treatment or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tychan Pte Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jenny Low, MBBS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649515
- Sponsor's protocol ID
- SCT-301
- Status last verified
- Mar 2022
- First submitted
- 26 Nov 2020
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Multi-Site, Randomised, Placebo Controlled, Double Blind, Single Dose Study of TY027 for Early Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04649515
- Acronym / sponsor ID
- SCT-301
- Conditions
- Coronavirus Disease-2019 (COVID-19)
- Keywords
- Coronavirus Disease-2019, COVID-19, SARS-CoV-2, Monoclonal Antibody, Infectious diseases, Phase 3 study, Singapore
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Tychan Pte Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 2 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.
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 droplets/close 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. Tychan's 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; ClinicalTrials.gov Identifier NCT04429529) reveals that TY027 is safe \& well-tolerated up to 20 mg/kg 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 1,305 COVID-19 patients will be enrolled. The first 15 patients will be randomised 1:1:1 to receive either (i) a single fixed dose of 1,500 mg TY027, (ii) a single fixed dose of 2,000 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 1:1 to receive either a single fixed dose of 2,000 mg TY027 (2,000 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 events/parameters 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 visit(s).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants are assigned to either treatment or placebo
| Arm | Type | Receives |
|---|---|---|
| TY027 1,500 mg | Experimental | Biological: TY0271,500 mg of TY027 will be administered via IV infusion over a period of 30 minutes. |
| TY027 2,000 mg | Experimental | Biological: TY0272,000 mg of TY027 will be administered via IV infusion over a period of 30 minutes. |
| Placebo | Placebo comparator | Other: 0.9% salinePlacebo will be administered via IV infusion over a period of 30 minutes. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Symptomatic and RT-PCR confirmed COVID-19 within 6 days from symptom onset.
- Has any one of the following factors associated with disease progression:
- Disease outcome score of 6, 7 or 8 based on the COVID Scale
- Willing to comply with the requirements of the study protocol and attend scheduled study visits
- Can give written informed consent approved by the Ethical Review Board governing the site
Key exclusion criteria (11 listed)
- Aged below 21 years old
- Female who is pregnant or breast-feeding
- With the following conditions, but not limited to:
- History of any allergic reaction to monoclonal antibodies
- Currently enrolled in another COVID-19 investigational drug study
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 |
|---|---|---|
| TY027TY027 Injection, (100 mg/5 mL/Vial), SARS-CoV-2 Monoclonal Antibody (mAb) - 1,500 mg of TY027 | Biological | TY027 1,500 mg |
| TY027TY027 Injection, (100 mg/5 mL/Vial), SARS-CoV-2 Monoclonal Antibody (mAb) - 2,000 mg of TY027 | Biological | TY027 2,000 mg |
| 0.9% salinePlacebo | Other | Placebo |
Primary outcome
To evaluate the efficacy of a single dose intravenous (IV) infusion of TY027 in reducing disease progression, defined as progression to score 4 and below on COVID scale
Time frame: Within the first 14 days
Proportion of COVID-19 patients with disease progression, defined as progression to score 4 and below on the COVID Scale, within the first 14 days after a single dose IV infusion of TY027 as compared to placebo
6 secondary outcomes
Rate of AEs (grade 3 and above) and SAEs in COVID-19 patients
Time frame: 28 days
All cause mortality rate
Time frame: 28 days
Proportion of subjects in categories 4, 3, 2 and 1 of the COVID scale
Time frame: Up to Day 28
Number of days COVID-19 patients require supplemental oxygen, high flow oxygen, non-invasive and invasive mechanical ventilation (if applicable)
Time frame: 28 days
Proportion of COVID-19 patients tested negative for SARS-CoV-2 via reverse transcriptase-polymerase chain reaction (RT-PCR)
Time frame: Up to Day 28
Proportion of COVID-19 patients with a minimum of 0.5 log time-weighted viral load reduction from saliva samples, via sub-genomic qRT-PCR
Time frame: Day 7 post-dose or day of discharge, whichever is earlier
Results and safety
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- 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.
Jenny Low, MBBS principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TY027 and 0.9% saline in people with Coronavirus Disease-2019 (COVID-19), run by Tychan Pte Ltd. at 1 site in Singapore.
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 12 inclusion and 11 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: stopped early, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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 was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
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?
To evaluate the efficacy of a single dose intravenous (IV) infusion of TY027 in reducing disease progression, defined as progression to score 4 and below on COVID scale (time frame: Within the first 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 NCT04649515, which also lists 1 linked publication.
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 24 Mar 2022.