| Trial registration number
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NCT04456153 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04456153
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First author
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Mamta Jain
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Contact
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Mamta.Jain@UTSouthwestern.edu
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-07-02
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Recruitment status
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
diagnosis of covid-19 by positive rt-pcr requiring hospitalization within 72 hours
age ≥18 years old
able to provide informed consent, or (as allowed by irb), immediate availability of designated legally authorized representative to provide consent by proxy
anticipated hospitalization for >48 hours
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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participation in any other clinical trial with antiviral activity against covid-19
breastfeeding women
known hypersensitivity to atovaquone or formulation excipient
active treatment with rifampin
hiv patients with aids requiring treatment for pneumocystis jirovecii or toxoplasma gondii
not expected to survive for 72 hours. 7) >14 days from symptom onset
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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University of Texas Southwestern Medical Center
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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United States
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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No restriction on type of patients
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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0: No restriction on type of patients
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Total sample size
Last imported at : Dec. 16, 2021, 2 a.m.
Source : ClinicalTrials.gov
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60
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primary outcome
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Primary Analysis
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
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Phase 2
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 138, "treatment_name": "Atovaquone", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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