Efficacy and Safety of Ivermectin for Treatment and Prophylaxis of COVID-19 Pandemic
Covid19
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Ivermectin, COVID-19, Hydroxychloroquine
Eligibility Criteria
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.
Sites / Locations
- Benha Faculty of Medicine, Benha University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Ivermectin plus standard care in Mild/Moderate COVID-19 (Group I)
hydroxychlorquine plus standard care in Mild/Moderate COVID-19 (Group II)
Ivermectin plus standard care and steroids in Sever COIVD-19 (Group III)
hydroxychlorquine plus standard care and steroids in Sever COVID-19 (Group IV)
Ivermectin plus personal protective measures in COVID-19 prophylaxis (Group V)
Personal protective measures in COVID-19 prophylaxis (Group VI)
100 patients with Mild/Moderate COVID-19 (Coronavirus disease) infection received a 4-days course of Ivermectin 400 mcg/kg body weight maximum 4 tablets (6mg / tablet) once daily dose before breakfast plus standard of care as issued by Egyptian protocol of COVID-19 treatment.
100 patients with mild/moderate COVID-19 infection received hydroxychlorquine (400 every 12 hours for one day followed by 200 mg every 12 hours for 5 days) plus standard care.
100 patients with severe COVID-19 infection received a 4 days course of Ivermectin 400 mcg/kg body weight maximum 4 tablets (6mg / tablet) once daily dose before breakfast plus standard care and steroids
100 patients with Severe COVID-19 infection received hydroxychlorquine (400 mg every 12 hours for one day followed by 200 mg every 12 hours for 9days) plus standard care and steroids
100 health care and or household contacts received a prophylactic dose of ivermectin 400 micrograms/kg single oral dose before breakfast to be repeated after one week in addition to Personal Protective Measures ( (hand hygiene, social distancing measures, avoiding touching the eyes, nose and mouth, Masks, respiratory etiquette, and self-isolation)
100 health care and or household contacts received only Personal Protective Measures (hand hygiene, social distancing measures, avoiding touching the eyes, nose and mouth, Masks, respiratory etiquette, and self-isolation)