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| Column | Value |
|---|---|
| Trial registration number | NCT05373446 |
|
Full text link
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
angenqiang@simcere.com |
|
Registration date
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
2022-05-13 |
|
Recruitment status
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
unclear |
|
Study aim
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
inclusion criteria: ≥18 and ≤80 years old, male or female. asymptomatic infection,mild or common type of covid-19. initial positive test of sars-cov-2 within 5 days of randomization. initial onset of covid-19 signs/symptoms within 3 days of randomization. |
|
Exclusion criteria
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ecmo is required or anticipated to be urgently required. prior to current disease episode, any confirmed sars-cov-2 infection. known medical history of active liver disease (other than nonalcoholic hepatic steatosis). receiving dialysis or have known moderate to severe renal impairment. known human immunodeficiency virus (hiv) infection. suspected or confirmed concurrent active systemic infection other than covid-19 that may interfere with the evaluation of response to the study intervention. oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization.. treatment with antivirals against sars-cov-2 within 14 days. current or expected use of any medications or substances that are highly dependent on cyp3a4 for clearance. concomitant use of any medications or substances that are strong inducers of cyp3a4 are prohibited within 28 days. has received or is expected to receive covid-19 monoclonal antibody, convalescent covid-19 plasma or other prohibited concomitant medication. females who are pregnant or breastfeeding. |
|
Number of arms
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Jiangsu Simcere Pharmaceutical Co., Ltd. |
|
Inclusion age min
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
80 |
|
Countries
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
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Total sample size
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
72 |
|
primary outcome
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Time to first nucleic acid turning negative |
|
Notes
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : May 14, 2022, 7 a.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : May 25, 2022, 10:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "SSD8432 300mg", "treatment_id": 2475, "treatment_name": "Ssd8432+ritonavir", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "SSD8432 750mg", "treatment_id": 2475, "treatment_name": "Ssd8432+ritonavir", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |