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| Column | Value |
|---|---|
| Trial registration number | NCT04341727 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Michael Klebert, mklebert@wustl.edu (PI email not reported) |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-10 |
|
Recruitment status
Last imported at : Oct. 8, 2021, 12:30 p.m. Source : ClinicalTrials.gov |
Terminated |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - hospitalization for management of sars cov-2 infection - positive sars cov-2 test - age >=18 years - provision of informed consent - electrocardiogram (ecg) ≤48 hours prior to enrollment - complete blood count, glucose-6 phosphate-dehydrogenase (g6pd), comprehensive metabolic panel and magnesium ≤48 hours prior to enrollment from standard of care. - if participating in sexual activity that could lead to pregnancy, individuals of reproductive potential who can become pregnant must agree to use contraception throughout the study. at least one of the following must be used throughout the study: - condom (male or female) with or without spermicide - diaphragm or cervical cap with spermicide - intrauterine device (iud) - hormone-based contraceptive |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- contraindication or allergy to chloroquine, hydroxychloroquine or azithromycin - current use hydroxychloroquine, chloroquine or azithromycin - concurrent use of another investigational agent - invasive mechanical ventilation - participants who have any severe and/or uncontrolled medical conditions such as: - unstable angina pectoris, - symptomatic congestive heart failure, - myocardial infarction, - cardiac arrhythmias or know prolonged qtc >470 males, >480 female on ecg - pulmonary insufficiency, - epilepsy (interaction with chloroquine), - prior retinal eye disease - concurrent malignancy requiring chemotherapy - known chronic kidney disease, egfr<10 or dialysis - g-6-pd deficiency, if unknown requires g6pd testing prior to enrollment - known porphyria - known myasthenia gravis - currently pregnant or planning on getting pregnant while on study - breast feeding - ast/alt >five times the upper limit of normal uln* - bilirubin >five times the uln* - magnesium <1.4 meq/l* - calcium <8.4mg/dl >10.6mg/dl* - potassium <3.3 >5.5 meg/l* |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Washington University School of Medicine |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : April 26, 2024, noon Source : ClinicalTrials.gov |
30 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Hours to recovery |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1454, "treatment_name": "Azithromycin+chloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}] |