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| Column | Value |
|---|---|
| Trial registration number | NCT04885530 |
|
Full text link
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : May 8, 2023, midnight Source : ClinicalTrials.gov |
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Contact
Last imported at : May 8, 2023, midnight Source : ClinicalTrials.gov |
rhonda.wilder@duke.edu |
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Registration date
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-05-13 |
|
Recruitment status
Last imported at : June 12, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - completed informed consent - age ≥ 30 years old - confirmed sars-cov-2 infection by any authorized or approved polymerase chain reaction (pcr) or antigen test collected within 10 days of screening - two or more current symptoms of acute infection for ≤7 days. symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell |
|
Exclusion criteria
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- prior diagnosis of covid-19 infection (> 10 days from screening) - current or recent (within 10 days of screening) hospitalization - known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo - known contraindication(s) to study drug including prohibited concomitant medications |
|
Number of arms
Last imported at : Feb. 3, 2023, 8 p.m. Source : ClinicalTrials.gov |
12 |
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Funding
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Susanna Naggie, MD |
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Inclusion age min
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
30 |
|
Inclusion age max
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Moderate disease at enrollment |
|
Severity scale
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
3: Moderate disease at enrollment |
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Total sample size
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
15000 |
|
primary outcome
Last imported at : May 8, 2023, midnight Source : ClinicalTrials.gov |
Time to sustained recovery in Days |
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Notes
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Feb. 3, 2023, 8 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "300-400 \u00b5g/kg", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Ivermectin", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "50 mg twice a day", "treatment_id": 522, "treatment_name": "Fluvoxamine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Fluvoxamine", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 1843, "treatment_name": "Fluticasone", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Fluticasone", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "400-600 \u00b5g/kg", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Ivermectin", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "50 mg twice a day for 1 day, followed by a dose of 100 mg twice a day", "treatment_id": 522, "treatment_name": "Fluvoxamine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Fluvoxamine 100", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 816, "treatment_name": "Montelukast", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Montelukast", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |