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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04668469
Recruitment Status : Completed
First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed G Elgazzar, Benha University

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 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.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Ivermectin Drug: Hydroxychloroquine Behavioral: personal protective Measures Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A multicenter randomized double blind controlled clinical trial (RCCT) study design was carried out on on 600 subjects; 400 patients and 200 health care and household contacts at Benha and Kafrelsheikh University Hospitals.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Randomization A Block randomization method was used to randomize the study participants into two groups that result in equal sample sizes. This method was used to ensure a balance in sample size across groups over time and keep the numbers of participants in each group similar at all times.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ivermectin for Treatment and Prophylaxis of COVID-19 Pandemic
Actual Study Start Date : June 8, 2020
Actual Primary Completion Date : September 15, 2020
Actual Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Ivermectin plus standard care in Mild/Moderate COVID-19 (Group I)
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.
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
Other Names:
  • Azithromycin
  • Paracetamol
  • Vitamin C
  • Zinc
  • Lactoferrin
  • Acetylcystein
  • prophylactic or therapeutic anticoagulation if D-dimer > 1000
  • systemic steroid if needed

Active Comparator: hydroxychlorquine plus standard care in Mild/Moderate COVID-19 (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.
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
Other Names:
  • Azithromycin
  • Paracetamol
  • Vitamin C
  • Zinc
  • Lactoferrin
  • Acetylcystein
  • prophylactic or therapeutic anticoagulation if D-dimer > 1000
  • systemic steroid if needed

Experimental: Ivermectin plus standard care and steroids in Sever COIVD-19 (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 and steroids
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
Other Names:
  • Azithromycin
  • Paracetamol
  • Vitamin C
  • Zinc
  • Lactoferrin
  • Acetylcystein
  • prophylactic or therapeutic anticoagulation if D-dimer > 1000
  • systemic steroid if needed

Active Comparator: hydroxychlorquine plus standard care and steroids in Sever COVID-19 (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 9days) plus standard care and steroids
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
Other Names:
  • Azithromycin
  • Paracetamol
  • Vitamin C
  • Zinc
  • Lactoferrin
  • Acetylcystein
  • prophylactic or therapeutic anticoagulation if D-dimer > 1000
  • systemic steroid if needed

Experimental: Ivermectin plus personal protective measures in COVID-19 prophylaxis (Group V)
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)
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
Other Names:
  • Azithromycin
  • Paracetamol
  • Vitamin C
  • Zinc
  • Lactoferrin
  • Acetylcystein
  • prophylactic or therapeutic anticoagulation if D-dimer > 1000
  • systemic steroid if needed

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

Active Comparator: Personal protective measures in COVID-19 prophylaxis (Group VI)
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)
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




Primary Outcome Measures :
  1. number of participants with improvement of clinical condition (symptoms and signs) [ Time Frame: 3 months ]
    improvement of dyspnea using mMRC scale, disappearance of fever using thermometer, Fatigue using Fatigue Assessment Scale (FAS), and improvement of Oxygen saturation using pulse oximeter.

  2. Reduction of recovery time, hospital stay days and mortality rate [ Time Frame: 3 months ]
    recording days of clinical improvement (recovery time) , hospital stay days and mortality rate


Secondary Outcome Measures :
  1. improvement of laboratory investigations and 2 consecutive negative PCR tests taken at least 48 hours apart. [ Time Frame: 3 months ]
    improvement of laboratory investigations (CBC, CRP, Ferritin, D-dimer) and 2 consecutive negative PCR tests taken at least 48 hours apart.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04668469


Locations
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Egypt
Benha Faculty of Medicine, Benha University
Banhā, Qaluopia, Egypt, 13518
Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: Ahmed G Elgazzar, M.D. Peofessor of Chest diseases, Faculty of Medicine, Benha University, Egypt.
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Responsible Party: Ahmed G Elgazzar, Professor of Chest diseases and Tuberculosis, Benha University
ClinicalTrials.gov Identifier: NCT04668469    
Other Study ID Numbers: Re96.2020
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed G Elgazzar, Benha University:
Ivermectin
COVID-19
Hydroxychloroquine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Acetaminophen
Vitamins
Ascorbic Acid
Zinc
Azithromycin
Hydroxychloroquine
Ivermectin
Lactoferrin
Fibrin fragment D
Micronutrients
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Anti-Bacterial Agents
Anti-Infective Agents