Inhaled Ivermectin and COVID-19

COVID-19 Clinical Trial

— CCOVID-19  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04681053
• Other study ID #: R.20.11.1090.R1
• Status: Recruiting
• Phase: Phase 3
• Start date: February 25, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: Mansoura University
• Contact: Mahmoud El-Bendary, M.D
• Phone: 00201002592205
• Email: mmelbendary[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Ivermectin Powder
- Administration through inhalation (6mg) BID for 3 days

Locations

Country	Name	City	State
Egypt	Mansoura Faculty of Medicine	Mansoura	Dakahlyia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	resolution of pneumonia	The score severity index of pneumonia will be measured before and after receiving treatment by computed tomography (CT)(index from 0-20)increasing the index means increase severity.	througout the study completion up to one year (for every case must be done after 2 weeks from the start of treatment).