COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04649515

Jenny Low

Not reported

2020-12-02

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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 and above 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

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 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

3

Tychan Pte Ltd.

21

100

Singapore

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

17

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

None

Phase 3

[{"arm_notes": "1500mg", "treatment_id": 1323, "treatment_name": "Ty027", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "2000mg", "treatment_id": 1323, "treatment_name": "Ty027", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]