Ivermectin Versus Standard Treatment in Mild COVID-19

NCT04937569 | Unknown Phase 3

• 1 other identifier: AssiutU-Ivercom
• Study Type: interventional
• Target: 1,644
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Ivermectin, an inexpensive and available antiparasitic drug, with favourable safety profile, showed inhibitory effect on SARS-CoV2 viral replication in-vitro and in animal models. Several research groups investigated Ivermectin in COVID-19, particularly in mild symptomatic disease. There is high degree of uncertainty on its effects on clinical outcomes and larger studies are needed. Objectives: Plan to study the effect of Ivermectin versus standard treatment in patients with confirmed mild COVID-19. Study design: Multi-centre prospective cohort study Settings: Assiut University Hospital (Assiut University), Aswan and others, Egypt. Study Population: Patients with confirmed mild COVID-19. Intervention: Patients with mild symptomatic COVID-19 attending the participating out-patient clinics in different centers will receive either Ivermectin + Standard treatment or Standard treatment only. All new mild symptomatic COVID-19 patients will receive Ivermectin + Standard treatment for the first two weeks of the study. During the following four weeks, all new patients will receive standard treatment only. These cycles will be repeated until 822 patients are recruited in each arm. Patients assigned to Ivermectin + Standard treatment or standard treatment only will remain as such throughout the study and during the follow- up period. Primary outcome measures: The primary outcome will be rate of intensive care admission. Secondary outcome measures: Secondary outcomes will be time to clinical improvement, the clinical state using 7-point ordinal scale at different time points, need for home oxygenation, hospitalization, hospital supplemental oxygen \>24 hours, Non- invasive ventilation ( High- flow nasal cannula, High- velocity nasal insufflation or BiPAP), duration of hospitalization, duration of ICU stay and deaths within 21 days,. Power calculation: With a prospective cohort design, a sample size of 822 cases per group is estimated (1644 for the whole study). This calculation depends on a rate of ICU admission in mild symptomatic COVID-19 cases of 8.5%, an assumption that Ivermectin can reduce this rate by 50%, at a study power of 80%, and confidence limit of 0.95.

Conditions

Covid19

Keywords

COVID-19; Ivermectin; Standard therapy; ICU admission; Clinical improvement; Side effects; Effectiveness

Outcome Measures

Primary Outcomes (1)

• Rate of ICU admission in mild COVID-19 cases

  Indications of ICU admission, Respiratory rate (RR) \> 30 cycle/min, Oxygen saturation \< 92% at room air, PaO2/FiO2 ratio \< 300, Chest radiography showing more than 50% lung lesions, or progressive lesions within 24-48 hours, Critically ill if RR \> 30, Oxygen saturation \< 92%, or PaO2/FiO2 ratio \< 200 despite oxygen therapy.

  21 days

Secondary Outcomes (4)

• Time to clinical improvement.

  21 days

• Overall clinical state, using the 7-point ordinal scale

  21 days

• The duration of critical care interventions in each arm of the study.

  21 Days

• • Proportion of subjects who develop adverse events associated with the study drug.

  21 days

Study Arms (2)

Group 1: Ivermectin + standard treatment

ACTIVE COMPARATOR

Patients will receive 4-days course of Ivermectin 400 microgram/kg body weight maximum 4 tablets (6mg / tablet) once daily dose before breakfast plus standard treatment (Azithromycin 500mg once daily for 5 days, Paracetamol 500mg every 8 hours, vitamin C 1gm once daily, Zinc 50 mg once daily, Lactoferrin 100mg sachets twice daily and prophylactic or therapeutic anticoagulation if D-dimer is elevated.

Drug: Ivermectin Tablets

Group-2: Standard treatment only

OTHER

This group will receive the standard treatment protocol as outlined above according to the Egyptian Ministry of Health protocol of treating cases with mild COVID-19.

Drug: Ivermectin Tablets

Interventions

Ivermectin Tablets DRUG

4-days course of Ivermectin 400 microgram/kg body weight maximum 4 tablets (6mg / tablet) once daily dose before breakfast

Group 1: Ivermectin + standard treatment; Group-2: Standard treatment only

Eligibility Criteria

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

You may qualify if:

• Confirmed mild cases of COVID-19 defined as: symptomatic patients with any of COVID-19 symptoms (fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell),
• In addition to absolute leucopoenia (\< 4000) / absolute lymphopenia (\< 1000), positive CRP (C-reactive protein), high serum ferritin and/or positive PCR for SARS-CoV-2 in nasopharyngeal swab.
• no dyspnea and no abnormalities on high resolution chest imaging (HRCT).
• Patients should be at home (not admitted to hospital) with no supplemental oxygen treatment.

You may not qualify if:

• Asymptomatic patients
• Dyspnoea or abnormalities on chest imaging
• Hospital admission
• Severe pneumonia
• Impairment in liver functions
• Received Ivermection in the last 5 days before being included in the study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Aliae AR Mohamed-Hussein

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

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

Study Officials

• Aliae AR Mohamed-Hussein, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Essam R Othman, MD

  Assiut University

  STUDY DIRECTOR

• Ben WJ Mol, MD

  Monash University

  STUDY CHAIR

Central Study Contacts

Aliae AR Mohamed-Hussein, MD

CONTACT

01222302352; aliaehussein@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pulmonology

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 24, 2021
• Study Start: July 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)