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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04644185 |
|
Full text link
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
ji_qi@sinocelltech.com |
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Registration date
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2020-11-25 |
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Recruitment status
Last imported at : April 9, 2023, midnight Source : ClinicalTrials.gov |
Unknown |
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Study design
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Adaptive |
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Masking
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - hospitalized patients with severe covid-19 (5 point on nih 8-point ordinal scale). - male or female adult ≥18 years of age at time of enrollment; - biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as sars-cov-2 infection (pcr or antigen-based diagnostic tests); - ≤ 10 days since symptoms of covid-19 onset. |
|
Exclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- patients who need non-invasive ventilation or high flow oxygen (i.e., 6 point on the 8-point ordinal scale); - patients with critical covid-19; - patients with severe covid-19 who received convalescent plasma or covid-19 vaccine, or anti-sars-cov-2 spike (s) protein targeted therapy; - alanine-amino transferase (alt) or aspartate transaminase (ast) is 5 times higher than the upper limit of the normal value; - estimated glomerular filtration rate (egfr) <30 ml/min or on dialysis {egfr calculated by cockcroft-gault formula (cockcroft dw, 1976), male: crcl (ml/min) = [(140 - age) × weight (kg)] × 1/ [scr (mg/dl) × 72]; female: crcl (ml/min) = [(140 - age) × weight (kg)] × 0.85/ [scr (mg/dl) × 72]}. |
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Number of arms
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Sinocelltech Ltd. |
|
Inclusion age min
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : April 14, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Argentina;Brazil;Chile;Colombia;Mexico;Peru;United States |
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Type of patients
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
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Severity scale
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
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Total sample size
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
795 |
|
primary outcome
Last imported at : Dec. 25, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
The clinical efficacy of SCTA01 (Phase II and III) |
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Notes
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
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Arms
Last imported at : Nov. 27, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "low dose", "treatment_id": 1175, "treatment_name": "Scta01", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "high dose", "treatment_id": 1175, "treatment_name": "Scta01", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |