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Trial - NCT04668469


Column Value
Trial registration number NCT04668469
Full text link
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04668469

First author
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Ahmed G Elgazzar

Contact
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-12-16

Recruitment status
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: patients who have been diagnosed with covid-19 infection with at least one positive rt-pcr result from nasopharyngeal/oropharyngeal swab, then subdivided patients into mild, moderate and sever stages.

Exclusion criteria
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- pregnancy and lactation, and critical cases defined as: occurrence of respiratory failure requiring mechanical ventilation; presence of shock; other organ failure that requires monitoring and treatment in the icu, [20]. - patients with hydroxychloroquine contra-indications: corrected qt interval (qtc) > 500 m/sec, myasthenia gravis, porphyria, retinal pathology, epilepsy, glucose-6-phosphate dehydrogenase (g6pd) deficiency, allergy to 4-aminoquinolone, chronic heart, kidney or liver disease, and arrhythmias. - any patient demonstrates worsening of symptoms; radiological progression with virologically persistence within at least 7 days of the therapeutic evaluation period of the study after exclusion of cytokine storm was considered as a clinical failure and was shifted to the other management protocol. - treatment was terminated at any time by a multidisciplinary team if a serious side effect occurred, which was attributed to the medications used ,e.g. cardiac arrhythmia, deteriorated liver or kidney function or unfortunately patient died.

Number of arms
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

6

Funding
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Benha University

Inclusion age min
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Egypt

Type of patients
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Close contacts to covid patients

Severity scale
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

600

primary outcome
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

number of participants with improvement of clinical condition (symptoms and signs);Reduction of recovery time, hospital stay days and mortality rate

Notes
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 976, "treatment_name": "Personal protective measures", "treatment_type": "Protective device", "pharmacological_treatment": "Non pharmacological treatment"}]