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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05596045 |
|
Full text link
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
handan.he@ascletis.com |
|
Registration date
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
2022-10-27 |
|
Recruitment status
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
Sequential assignment |
|
Masking
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
inclusion criteria: male or female subjects aged ≥18 years at screening; those females who do not have plans for pregnancy within six months and are willing to take effective contraceptive measures from the first dose of the study drug to 3 months after the last dose; if male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug; has a documentation of pcr-confirmed sars-cov-2 infection with sample collection ≤5 days prior to randomization. |
|
Exclusion criteria
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
females who are pregnant, planning to become pregnant, or breastfeeding; has at least one characteristic or underlying medical condition associated with an increased risk of developing severe or critical illness from covid-19; has hypersensitivity or other contraindication to any of the components of the study interventions; has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments. |
|
Number of arms
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
Ascletis Pharmaceuticals Co., Ltd. |
|
Inclusion age min
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
|
Total sample size
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
32 |
|
primary outcome
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses;PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h |
|
Notes
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
Phase 1 |
|
Arms
Last imported at : Oct. 28, 2022, noon Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2641, "treatment_name": "Asc10", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |