Inhaled Ivermectin and COVID-19 (CCOVID-19)

February 22, 2021 updated by: Mahmoud Elbendary, Mansoura University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlyia
      • Mansoura, Dakahlyia, Egypt, 35516
        • Recruiting
        • Mansoura faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group (A) received both oral and inhaled ivermectin in addition to the standard of care.
use oral and inhaled ivermectin
Drug: Ivermectin Powder
- Administration through inhalation (6mg) BID for 3 days
Other Names:
  • Direct antiviarl agents
Active Comparator: B) received oral ivermectin in addition to the standard of care
receive oral ivermectin
Drug: Ivermectin Powder
- Administration through inhalation (6mg) BID for 3 days
Other Names:
  • Direct antiviarl agents
Active Comparator: c) received inhaled ivermectin in addition to the standard of care
received inhaled ivermectin
Drug: Ivermectin Powder
- Administration through inhalation (6mg) BID for 3 days
Other Names:
  • Direct antiviarl agents
No Intervention: Group (d) received the current standard of care only
received standard of care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of virological cure by Rt -PCR for COVID -19 using ivermectin when compared to standard treatment
Time Frame: througout the study completion up to one year(for every case must be done after 2 weeks from the start of 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
resolution of pneumonia
Time Frame: througout the study completion up to one year (for every case must be done after 2 weeks from the start of treatment).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 25, 2021

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

December 21, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.20.11.1090.R1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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