NCT04668469

Efficacy and Safety of Ivermectin for Treatment and Prophylaxis of COVID-19 Pandemic

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 study aims to evaluate the anti-parasitic medication efficacy "Ivermectin" plus standard care (Azithromycin, Paracetamol, vitamin C, Zinc, Lactoferrin, Acetylcystein, prophylactic or therapeutic anticoagulation if D-dimer \> 1000 and/or steroids) in the treatment of mild/moderate and severely ill cases with COVID 19 infection versus Hydroxychloroquine plus standard care, as well as Ivermectin prophylaxis of health care and/ or household contacts. Subject and methods: 600 subjects; 400 symptomatic confirmed COVID-19 patients and 200 health care and household contacts distributed over 6 groups; Group I: 100 patients with Mild/Moderate COVID-19 infection received a 4-days course of Ivermectin plus standard care; Group II: 100 patients with mild/moderate COVID-19 infection received hydroxychlorquine plus standard care; Group III: 100 patients with severe COVID-19 infection received Ivermectin plus standard of care; Group IV: 100 patients with Severe COVID-19 infection received hydroxychlorquine plus standard care. Routine laboratory investigations and real time- polymerase chain reaction (rt-PCR) were reported before and after initiation of treatment. Group V stick to personal protective equipment (PPE) plus Ivermectin, and Group VI stick to PPE only and both groups were followed for two weeks.

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 2020. \*Study population (Sampling Design and Sample Size): The study was conducted on 600 subjects; 400 patients and 200 health care and household contacts that were divided into 6 groups: * Group I: 100 patients with Mild/Moderate 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 as issued by Egyptian protocol of COVID-19 treatment (Azithromycin 500mg once daily/5days, Paracetamol 500mg as needed, vitamin C 1gm once daily, Zinc 50 mg once daily, Lactoferrin 100mg sachets/12 hours \& Acetylcystein 200mg/8hours \& prophylactic or therapeutic anticoagulation if D-dimer \> 1000), (MOH version 30 May 2020). * Group II: 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 (Azithromycin 500mg once daily/5days, Paracetamol 500mg as needed, vitamin C 1gm once daily, Zinc 50 mg once daily, Lactoferrin 100mg sachets /12 hours \& Acetylcystein 200mg sachets /8 hours \& prophylactic or therapeutic anticoagulation if D-dimer \> 1000) as issued by Egyptian protocol of COVID-19 treatment. * Group III: 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 (Azithromycin 500mg once daily/5days, Paracetamol 500mg as needed, vitamin C 1gm once daily, Zinc 50 mg once daily, Lactoferrin 100mg sachets/ 12 hours \& Acetylcystein 200mg sachets/ 8 hours \& prophylactic or therapeutic anticoagulation if D-dimer \> 1000) as issued by Egyptian protocol of COVID-19 treatment for severe patients. * Group IV: 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 9 days) plus standard care (Azithromycin 500mg once daily/5days, Paracetamol 500mg as needed, vitamin C 1gm once daily, Zinc 50 mg once daily, Lactoferrin 100mg/12 hours \& Acetylcystein 200mg sachets/ 8 hours \& prophylactic or therapeutic anticoagulation if D-dimer \> 1000) as issued by Egyptian protocol of COVID-19 treatment for severe ill patients. * Group V: 100 health care and or household patients' contacts received a prophylactic dose of ivermectin 400 micrograms/kg single oral dose before breakfast to be repeated after one week in addition to PPE (personal protective equipment). * Group VI: 100 health care and or household patients' contacts received only PPE (personal protective equipment). Study methods and Tools: All patients were subjected to: * Full history and clinical examination taking, and laboratory assessment including liver function tests, kidney function tests, full blood count, serum Ferritin level. C-reactive protein (CRP), D-dimer, rt- PCR for COVID-19 and, radiological assessments including CT chest. * Follow up: Patients were followed up daily clinically and by laboratory assessment for two weeks but radiological assessment after two weeks or until one of the endpoints is reached. Follow up the duration of treatment, swab conversion, hospital stay, the clinical and radiological improvement was recorded.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Ivermectin	evaluation of the anti-parasitic medication efficacy "Ivermectin" (Ivermectin 400 mcg/kg body weight maximum 4 tablets (6mg / tablet) once daily dose before breakfast) plus standard care in the treatment of mild/moderate cases with COVID 19 infection
DRUG	Hydroxychloroquine	evaluation of hydroxychlorquine (400 every 12 hours for one day followed by 200 mg every 12 hours for 5 days) plus standard care in the treatment of mild/moderate cases with COVID 19 infection
BEHAVIORAL	personal protective Measures	evaluation of personal protective Measures (hand hygiene, social distancing measures, avoiding touching the eyes, nose and mouth, wearing masks, and self-isolation) only as a prophylaxis for health care and or household contacts' from COVID-19 disease

Timeline

• Start date: 2020-06-08
• Primary completion: 2020-09-15
• Completion: 2020-10-30
• First posted: 2020-12-16
• Last updated: 2020-12-16

Locations

1 site across 1 country: Egypt