Inhaled Ivermectin and COVID-19

NCT04681053 | Unknown Phase 3

• 1 other identifier: R.20.11.1090.R1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease-19 is global healthcare crisis. Till May 20, 2020, there were approximately 4,789,205 cases and 318,789 related mortalities were identified globally. This dramatic situation led to healthcare service collapse in many countries. Each country developed its own action plan depending on healthcare expertise and the available resources. There is no definitive therapy for Coronavirus disease-19 up till now. Many current and investigational drugs are used nowadays. Recent reports suggest a beneficial role of Ivermectin in the management of Coronavirus disease-19. A notice that necessitates further clinical studies. The aim of this study is to assess the efficacy and safety of the usage of inhaled ivermectin in the management of Coronavirus disease-19.

Conditions

COVID-19

Keywords

COVID; Ivermectin; Inhalation; Antiviral; safety

Outcome Measures

Primary Outcomes (1)

• Rate of virological cure by Rt -PCR for COVID -19 using ivermectin when compared to standard treatment

  All PCR for COVID-19 must be negative

  througout the study completion up to one year(for every case must be done after 2 weeks from the start of treatment).

Secondary Outcomes (1)

• resolution of pneumonia

  througout the study completion up to one year (for every case must be done after 2 weeks from the start of treatment).

Study Arms (4)

Group (A) received both oral and inhaled ivermectin in addition to the standard of care.

ACTIVE COMPARATOR

use oral and inhaled ivermectin

Drug: Ivermectin Powder

B) received oral ivermectin in addition to the standard of care

ACTIVE COMPARATOR

receive oral ivermectin

Drug: Ivermectin Powder

c) received inhaled ivermectin in addition to the standard of care

ACTIVE COMPARATOR

received inhaled ivermectin

Drug: Ivermectin Powder

Group (d) received the current standard of care only

NO INTERVENTION

received standard of care only

Interventions

Ivermectin Powder DRUG

\- Administration through inhalation (6mg) BID for 3 days

Also known as: Direct antiviarl agents

B) received oral ivermectin in addition to the standard of care; Group (A) received both oral and inhaled ivermectin in addition to the standard of care.; c) received inhaled ivermectin in addition to the standard of care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sexes
• Age above 18
• Test positive for COVID-19 using Reverse transcription polymerase chain reaction (RT-PCR) prior to the start of study.
• Willing to participate in the study
• Mild to moderate severity index according to the WHO criteria

You may not qualify if:

• Hypersensitivity to the study drug.
• History of co-morbid conditions such as: uncontrolled hypertension and diabetes, retinal problems and chronic liver and renal disease.
• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Faculty of Medicine

Al Mansurah, Dakahlyia, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19; Respiratory Aspiration

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; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mahmoud El-Bendary, M.D

  Mansoura University- Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud El-Bendary, M.D

CONTACT

00201002592205; mmelbendary@gmail.com

Hatem Elalfy

CONTACT

00201224790518; elalfy_hatem66@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Tropical Medicine and Hepatogastroenterology

Model Details: All current study participants will be classified into 4 equal groups : Group (A) received both oral and inhaled ivermectin in addition to the standard of care. Group (B)received inhaled ivermectin only Group (C) received oral ivermectin in addition to the standard of care, Group (D) received the current standard of care only

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 23, 2020
• Study Start: February 25, 2021
• Primary Completion: April 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 24, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)