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Inhaled Ivermectin and COVID-19 (CCOVID-19)

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Ivermectin Powder
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID, Ivermectin, Inhalation, Antiviral, safety

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Mansoura Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

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

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

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

Group (d) received the current standard of care only

Arm Description

use oral and inhaled ivermectin

receive oral ivermectin

received inhaled ivermectin

received standard of care only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 16, 2020
Last Updated
February 22, 2021
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04681053
Brief Title
Inhaled Ivermectin and COVID-19
Acronym
CCOVID-19
Official Title
Efficacy and Safety of Inhaled Ivermectin in the Treatment of SARS-COV-2 (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2021 (Anticipated)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID, Ivermectin, Inhalation, Antiviral, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group (A) received both oral and inhaled ivermectin in addition to the standard of care.
Arm Type
Active Comparator
Arm Description
use oral and inhaled ivermectin
Arm Title
B) received oral ivermectin in addition to the standard of care
Arm Type
Active Comparator
Arm Description
receive oral ivermectin
Arm Title
c) received inhaled ivermectin in addition to the standard of care
Arm Type
Active Comparator
Arm Description
received inhaled ivermectin
Arm Title
Group (d) received the current standard of care only
Arm Type
No Intervention
Arm Description
received standard of care only
Intervention Type
Drug
Intervention Name(s)
Ivermectin Powder
Other Intervention Name(s)
Direct antiviarl agents
Intervention Description
- Administration through inhalation (6mg) BID for 3 days
Primary Outcome Measure Information:
Title
Rate of virological cure by Rt -PCR for COVID -19 using ivermectin when compared to standard treatment
Description
All PCR for COVID-19 must be negative
Time Frame
througout the study completion up to one year(for every case must be done after 2 weeks from the start of treatment).
Secondary Outcome Measure Information:
Title
resolution of pneumonia
Description
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.
Time Frame
througout the study completion up to one year (for every case must be done after 2 weeks from the start of treatment).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud El-Bendary, M.D
Phone
00201002592205
Email
mmelbendary@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hatem Elalfy
Phone
00201224790518
Email
elalfy_hatem66@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud El-Bendary, M.D
Organizational Affiliation
Mansoura University- Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura Faculty of Medicine
City
Mansoura
State/Province
Dakahlyia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud El-Bendary, M.D
Phone
00201002592205
Email
mmelbendary@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Inhaled Ivermectin and COVID-19

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