NCT04649515.

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 Inpatient Recruitment period: between December 2020 and August 2021 Multicentre, country: Singapore Eligibility criteria Inclusion criteria 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 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 Exclusion criteria Aged < 21 years old Woman 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 > 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
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 Placebo, 0.9% saline, single dose, IV infusion
Outcomes	Efficacy outcomes All‐cause mortality at up to 30 days: planned at up to 60 days: not planned 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
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