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Trial - NCT05373433


Column Value
Trial registration number NCT05373433
Full text link
Last imported at : May 14, 2022, 7 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05373433

First author
Last imported at : May 14, 2022, 7 a.m.
Source : ClinicalTrials.gov

Genqiang An

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

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. initial positive test of sars-cov-2 within 5 days of randomization. mild or common type of covid-19. initial onset of covid-19 signs/symptoms within 3 days of randomization. fever or 1 respiratory symptom of covid-19 on random day subjects without high risk factors subjects with at least one high-risk factor

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

2

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

Type of patients
Last imported at : May 14, 2022, 7 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : May 14, 2022, 7 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : May 14, 2022, 7 a.m.
Source : ClinicalTrials.gov

670

primary outcome
Last imported at : May 14, 2022, 7 a.m.
Source : ClinicalTrials.gov

Time to Sustained Alleviation;Viral load

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/Phase 3

Arms
Last imported at : May 25, 2022, 10:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 2475, "treatment_name": "Ssd8432+ritonavir", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]