Study name |
NCT04649515 |
Methods |
Drug name: TY027 Trial design: randomised, placebo‐controlled, double‐blind, single‐dose, multi‐site, phase 3 study NCT number: NCT04649515 (date of trial registration: 2 December 2020) Target sample size: 1305 participants Planned completion date: December 2021 |
Participants |
Setting
Eligibility criteria
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Inclusion criteria
Symptomatic and RT‐PCR confirmed COVID‐19 within 6 days from symptom onset
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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
history of well‐controlled diabetes, hypertension, chronic obstructive lung disease or ischaemic 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
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Exclusion criteria
Aged < 21 years old
Woman who is pregnant or breast‐feeding
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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 > 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/1.73 m2 calculated by the CKD‐EPI formula
Suspected or confirmed active bacterial, fungal or mycobacterial infection
History of any allergic reaction to mAbs
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
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Interventions |
Intervention TY027
Target: SARS‐CoV‐2 S protein
Origin: fully engineered human IgG
Dose: 1.500 mg/2.000 mg
Frequency: single dose
Route of administration: IV infusion
Comparator
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Outcomes |
Efficacy outcomes
-
All‐cause mortality
Clinical progression/improvement of symptoms: planned
Length of hospital stay (for those admitted to hospital): not planned
Admission to ICU: not planned
Length of ICU stay: not planned
Quality of life, including fatigue: not planned
Viral clearance: planned
Thromboembolic events: not planned
Renal failure: not planned
Safety outcomes
Number of participants with AEs (all grades, grade 1‐2, grade 3‐4): planned
Number of participants with SAEs: planned
Additional study outcomes
Proportion of participants in categories 4, 3, 2 and 1 of the COVID scale
Number of days COVID‐19 patients require supplemental oxygen, high‐flow oxygen, non‐invasive and invasive mechanical ventilation (if applicable)
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
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Starting date |
December 2020 |
Contact information |
Justin Ng, +65 69046055, justin@tychanltd.com Anjali Baglody, +65 69046055, anjalib@tychanltd.com |
Notes |
Developer: Tychan Pte Ltd. Funding: Tychan Pte Ltd. Recruitment status: recruiting |