Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2021-02-25
2021-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
: 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
TREATMENT
NONE
Study Groups
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Group (A) received both oral and inhaled ivermectin in addition to the standard of care.
use oral and inhaled ivermectin
Ivermectin Powder
\- Administration through inhalation (6mg) BID for 3 days
B) received oral ivermectin in addition to the standard of care
receive oral ivermectin
Ivermectin Powder
\- Administration through inhalation (6mg) BID for 3 days
c) received inhaled ivermectin in addition to the standard of care
received inhaled ivermectin
Ivermectin Powder
\- Administration through inhalation (6mg) BID for 3 days
Group (d) received the current standard of care only
received standard of care only
No interventions assigned to this group
Interventions
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Ivermectin Powder
\- Administration through inhalation (6mg) BID for 3 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Mahmoud Elbendary
Professor of Tropical Medicine and Hepatogastroenterology
Principal Investigators
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Mahmoud El-Bendary, M.D
Role: PRINCIPAL_INVESTIGATOR
Mansoura University- Faculty of Medicine
Locations
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Mansoura Faculty of Medicine
Al Mansurah, Dakahlyia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R.20.11.1090.R1
Identifier Type: -
Identifier Source: org_study_id
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