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| Column | Value |
|---|---|
| Trial registration number | NCT05369676 |
|
Full text link
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 1, 2023, 8 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : June 1, 2023, 8 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
2022-05-11 |
|
Recruitment status
Last imported at : June 1, 2023, 8 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
inclusion criteria: age ≥18 and ≤75, 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. the ct value of sars-cov-2 nucleic acid test before randomization is ≤ 25, or the ct value is >25 and sars-cov-2 serum igg and igm are negative. |
|
Exclusion criteria
Last imported at : May 13, 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.s. 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 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
4 |
|
Funding
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Jiangsu Simcere Pharmaceutical Co., Ltd. |
|
Inclusion age min
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
75 |
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Countries
Last imported at : May 19, 2022, 8:39 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
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Total sample size
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
32 |
|
primary outcome
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Adverse events |
|
Notes
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : May 13, 2022, 7 a.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
|
Arms
Last imported at : May 19, 2022, 8:39 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "dose 1", "treatment_id": 2509, "treatment_name": "Ritonavir+ssd8432", "treatment_type": "Antivirals+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "dose 2", "treatment_id": 2509, "treatment_name": "Ritonavir+ssd8432", "treatment_type": "Antivirals+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}] |