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| Column | Value |
|---|---|
| Trial registration number | NCT05041907 |
|
Full text link
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
william@tropmedres.ac |
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Registration date
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
2021-09-13 |
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Recruitment status
Last imported at : Oct. 11, 2021, 1 p.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Adaptive |
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Masking
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : Jan. 14, 2022, 10 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Sept. 10, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study. previously healthy adults, male or female, aged 18 to 50 years at time of consent with early symptomatic covid-19 sars-cov-2 positive by lateral flow antigen test or a positive pcr test for sars-cov-2 within the last 24hrs with a ct value of less than 25 (all viral targets) symptoms of covid-19 (including fever, or history of fever) for less than 4 days (96 hours). oxygen saturation ≥96% measured by pulse-oximetry at time of screening. able to walk unaided and unimpeded in adls agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits |
|
Exclusion criteria
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
the patient may not enter the study if any of the following apply: - taking any concomitant medications or drugs (see appendix 4)† - presence of any chronic illness/ condition requiring long term treatment, or other significant comorbidity (e.g. diabetes, obesity but see appendix 4 for the full list) - laboratory abnormalities discovered at screening (see appendix 4) - for females: pregnancy, actively trying to become pregnant, or lactation - contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics (see appendix 4) - currently participating in another covid-19 therapeutic or vaccine trial - evidence of pneumonia (although imaging is not required) - healthy women on the oral contraceptive pill are eligible to join the study |
|
Number of arms
Last imported at : Jan. 11, 2023, 8 a.m. Source : ClinicalTrials.gov |
13 |
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Funding
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
University of Oxford |
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Inclusion age min
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
50 |
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Countries
Last imported at : Jan. 11, 2023, 8 a.m. Source : ClinicalTrials.gov |
Brazil;Lao People's Democratic Republic;Thailand |
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Type of patients
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
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Total sample size
Last imported at : Sept. 10, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
1500 |
|
primary outcome
Last imported at : Sept. 10, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Rate of viral clearance for newly available and repurposed drugs;Rate of viral clearance for positive controls (e.g. monoclonal antibodies);Rate of viral clearance for small novel molecule drugs |
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Notes
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Sept. 15, 2021, 4:30 a.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 2680, "treatment_name": "Ensitrelvir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 520, "treatment_name": "Fluoxetine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 813, "treatment_name": "Molnupiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2681, "treatment_name": "Molnupiravir+nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1864, "treatment_name": "Casirivimab+imdevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1465, "treatment_name": "Cilgavimab+tixagevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 888, "treatment_name": "Nitazoxanide", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1859, "treatment_name": "Sotrovimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |