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

NCT04668469 | Completed DMC

• 1 other identifier: Re96.2020
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Ivermectin; COVID-19; Hydroxychloroquine

Outcome Measures

Primary Outcomes (2)

• number of participants with improvement of clinical condition (symptoms and signs)

  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.

  3 months

• Reduction of recovery time, hospital stay days and mortality rate

  recording days of clinical improvement (recovery time) , hospital stay days and mortality rate

  3 months

Secondary Outcomes (1)

• improvement of laboratory investigations and 2 consecutive negative PCR tests taken at least 48 hours apart.

  3 months

Study Arms (6)

Ivermectin plus standard care in Mild/Moderate COVID-19 (Group I)

EXPERIMENTAL

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

hydroxychlorquine plus standard care in Mild/Moderate COVID-19 (Group II)

ACTIVE COMPARATOR

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

Ivermectin plus standard care and steroids in Sever COIVD-19 (Group III)

EXPERIMENTAL

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

hydroxychlorquine plus standard care and steroids in Sever COVID-19 (Group IV)

ACTIVE COMPARATOR

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

Ivermectin plus personal protective measures in COVID-19 prophylaxis (Group V)

EXPERIMENTAL

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; Behavioral: personal protective Measures

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

ACTIVE COMPARATOR

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

Interventions

Ivermectin DRUG

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

Also known as: Azithromycin, Paracetamol, Vitamin C, Zinc, Lactoferrin, Acetylcystein, prophylactic or therapeutic anticoagulation if D-dimer > 1000, systemic steroid if needed

Ivermectin plus personal protective measures in COVID-19 prophylaxis (Group V); Ivermectin plus standard care and steroids in Sever COIVD-19 (Group III); Ivermectin plus standard care in Mild/Moderate COVID-19 (Group I)

Hydroxychloroquine DRUG

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

Also known as: Azithromycin, Paracetamol, Vitamin C, Zinc, Lactoferrin, Acetylcystein, prophylactic or therapeutic anticoagulation if D-dimer > 1000, systemic steroid if needed

hydroxychlorquine plus standard care and steroids in Sever COVID-19 (Group IV); hydroxychlorquine plus standard care in Mild/Moderate COVID-19 (Group II)

personal protective Measures BEHAVIORAL

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

Ivermectin plus personal protective measures in COVID-19 prophylaxis (Group V); Personal protective measures in COVID-19 prophylaxis (Group VI)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha Faculty of Medicine, Benha University

Banhā, Qaluopia, 13518, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin; Azithromycin; Acetaminophen; Ascorbic Acid; Zinc; Lactoferrin; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Erythromycin; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ahmed G Elgazzar, M.D.

  Peofessor of Chest diseases, Faculty of Medicine, Benha University, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Chest diseases and Tuberculosis

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 16, 2020
• Study Start: June 8, 2020
• Primary Completion: September 15, 2020
• Study Completion: October 30, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

EG (1)