Status:
COMPLETED
Efficacy and Safety of Ivermectin for Treatment and Prophylaxis of COVID-19 Pandemic
Lead Sponsor:
Benha University
Conditions:
Covid19
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Background: Up-to-date, there is no recognized effective treatment or vaccine for the treatment of coronavirus disease (COVID-19) that emphasize urgency around distinctive effective therapies. This st...
Detailed Description
I-Technical design: Study design: interventional multicenter double blind randomized controlled clinical trial (RCCT) study Study period: The study was carried out from 8th June to 15th September 202...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04668469
Start Date
June 8 2020
End Date
October 30 2020
Last Update
December 16 2020
Active Locations (1)
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1
Benha Faculty of Medicine, Benha University
Banhā, Qaluopia, Egypt, 13518