Inhaled Ivermectin and COVID-19 (CCOVID-19)

Mansoura University

Status and phase: Unknown; Phase 3

Conditions: COVID-19

Treatments: Drug: Ivermectin Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT04681053

R.20.11.1090.R1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

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

Active Comparator group

Description:

use oral and inhaled ivermectin

Treatment:

Drug: Ivermectin Powder

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

Active Comparator group

Description:

receive oral ivermectin

Treatment:

Drug: Ivermectin Powder

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

Active Comparator group

Description:

received inhaled ivermectin

Treatment:

Drug: Ivermectin Powder

Group (d) received the current standard of care only

No Intervention group

Description:

received standard of care only