Ivermectin Nasal Spray for COVID19 Patients

Study Overview
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Brief Summary
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The global escalation of COVID19 pandemic has put the health care system under pressure with urgent need for treatment. In the absence of vaccine and approved drug against SARS-COV2 over the past 6 months, the health authorities were obliged to re-purpose existing drugs to fight this pandemic.

Detailed Description
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Ivermectin is a well-known FDA-approved pan antiparasitic drug with high safety profile and potential therapeutic effects against COVID 19. It has been previously investigated as an antiviral agent. It showed 5000 fold reduction of SARS COV 2 viral RNA in-vitro studies. However, some researchers questioned its efficacy in the oral form as very high doses will be required to achieve a proper tissue concentration and viricidal effect in the respiratory system. Our hypothesis is that, since COVID-19 has shown to be particularly damaging to the respiratory system, using inhaled forms of Ivermectin will deliver the drug directly to the infection site and make it a treatment option.

Official Title
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Ivermectin Inhalation Forms in the Management of COVID-19 Egyptian Patients

Conditions
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Covid19

Intervention / Treatment
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* Drug: Ivermectin nasal
* Drug: Ivermectin oral
* Other: standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild to moderate severity who are confirmed to be positive for SARS COV 2. Exclusion Criteria: patients with severe form of COVID-19 or those who are on ventilatory support or those with cytokine storm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ivermectin nasal spray<br>Ivermectin administered as nasal spray (one ml in each nostril two times daily) | Drug: Ivermectin nasal<br>* Ivermectin nasal spray one ml in each nostril two times daily<br>* Other names: ivermectin;|
| Experimental: Ivermectin oral<br>Ivermectin administered orally (one tablet 6 mg three times daily) for 72 hours plus the standard care of COVID-19 cases. | Drug: Ivermectin oral<br>* Ivermectin oral (one tablet 6 mg three times daily)<br>* Other names: ivermectin;|
| Experimental: standard care<br>COVID-19 cases will receive standard of care [oxygen via masks or ventilators] | Other: standard care<br>* oxygen via masks or ventilators<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR of SARS-Cov2 RNA | Negative PCR result of SARS-Cov2 RNA in COVID19 patients | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19