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Trial - NCT05156645


Column Value
Trial registration number NCT05156645
Full text link
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05156645

First author
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Reborn Luo

Contact
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

zibin_luo@sinocelltech.com

Registration date
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

2021-12-14

Recruitment status
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

inclusion criteria: male or non-pregnant female adults, ≥18 years old of age at the time of randomization; participants should have at least one of covid-19 risk factor; participants should have at least 2 covid-19 related symptoms; has symptoms consistent with covid-19 as determined by the investigator with onset ≤10 days before randomization; first positive sars-cov-2 viral infection tested (pcr or antigen-based diagnostic tests) in samples collected ≤5 days prior to start of the infusion;

Exclusion criteria
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema; have spo2 ≤ 93% on room air at sea level or pao2/fio2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (fda); require mechanical ventilation or anticipated impending need for mechanical ventilation; suspected or proven serious bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking part in this study; have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;

Number of arms
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Sinocelltech Ltd.

Inclusion age min
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Proportion of participants who experience COVID-19 related hospitalization (defined as at least 24 hours of acute care) or death (all cause) up to Day 29 (Phase III);Proportion of patients with ≥Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II)

Notes
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

Phase 1/Phase 2

Arms
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2097, "treatment_name": "Scta01+scta01c", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]