Ivermectin Nasal Spray for COVID19 Patients
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ClinicalTrials.gov Identifier: NCT04510233 |
Recruitment Status : Unknown
Verified August 2020 by Prof. Dr. Kamal Mohammed Okasha, Tanta University.
Recruitment status was: Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | August 10, 2020 | ||||
First Posted Date ICMJE | August 12, 2020 | ||||
Last Update Posted Date | August 12, 2020 | ||||
Estimated Study Start Date ICMJE | September 2020 | ||||
Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
PCR of SARS-Cov2 RNA [ Time Frame: 14 days ] Negative PCR result of SARS-Cov2 RNA in COVID19 patients
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Ivermectin Nasal Spray for COVID19 Patients | ||||
Official Title ICMJE | Ivermectin Inhalation Forms in the Management of COVID-19 Egyptian Patients | ||||
Brief Summary | 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 | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Covid19 | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2020 | ||||
Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04510233 | ||||
Other Study ID Numbers ICMJE | IvrInh | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Prof. Dr. Kamal Mohammed Okasha, Tanta University | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Tanta University | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Tanta University | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |