Official Title
Efficacy and Safety of Inhaled Ivermectin in the Treatment of SARS-COV-2 (COVID-19)
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.

Detailed Description

Coronavirus disease-19 (COVID-19) is a pandemic disease which is caused by the SARS-CoV2
virus. It is one of the biggest single-stranded RNA viruses. SARS-CoV2 Viral polyproteins are
responsible for viral replication and transcription while its protease enzymes are
responsible for polypeptides cleaving and immune system blockage. They are considered to be
an important therapeutic target.

Host immunological response against SARS-CoV2 could affect the disease outcome. Patients
requiring ICU admission have higher levels of interleukins 6 - 10, tumor necrosis factor α
(TNF-α), and fewer CD4+ and CD8+ T cells. The level of cytokines and lymphopenia is
associated with pulmonary damage and respiratory distress.

Till now, there is no definitive therapy for COVID-19. Multiple current and investigational
drugs are used such as Hydroxychloroquine, lopinavir/ritonavir, and Remdesivir.

Ivermectin: A potent anti-parasitic drug has shown to have an in-vitro antiviral activity
against a broad range of viruses. It inhibits the interaction between the human
immunodeficiency virus-1 (HIV-1) integrase protein (IN) and the importin (IMP) α/β1. But on
the other hand, Ivermectin showed limited efficacy against DENV in phase III clinical trial
that was done in Thailand in 2014-2017. Recent Studies proved the In-vitro effect and
"subsequently" the possible therapeutic role of Ivermectin in the management of SARS-CoV2.

Unknown status
COVID-19

Drug: Ivermectin Powder

- Administration through inhalation (6mg) BID for 3 days
Other Name: Direct antiviarl agents

Eligibility Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Egypt
Locations

Mansoura Faculty of Medicine
Mansoura, Dakahlyia, Egypt

Investigator: Mahmoud El-Bendary, M.D
Contact: 00201002592205
mmelbendary@gmail.com

Contacts

Mahmoud El-Bendary, M.D
00201002592205
mmelbendary@gmail.com

Hatem Elalfy
00201224790518
elalfy_hatem66@yahoo.com

Mahmoud El-Bendary, M.D, Principal Investigator
Mansoura University- Faculty of Medicine

Mansoura University
NCT Number
Keywords
Covid
Ivermectin
inhalation
Antiviral
safety
MeSH Terms
COVID-19
Ivermectin