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Ivermectin Nasal Spray for COVID19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510233
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Kamal Mohammed Okasha, Tanta University

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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Ivermectin nasal Drug: Ivermectin oral Other: standard care Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ivermectin Inhalation Forms in the Management of COVID-19 Egyptian Patients
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Ivermectin nasal spray
Ivermectin administered as nasal spray (one ml in each nostril two times daily)
Drug: Ivermectin nasal
Ivermectin nasal spray one ml in each nostril two times daily
Other Name: ivermectin

Experimental: Ivermectin oral
Ivermectin administered orally (one tablet 6 mg three times daily) for 72 hours plus the standard care of COVID-19 cases.
Drug: Ivermectin oral
Ivermectin oral (one tablet 6 mg three times daily)
Other Name: ivermectin

Experimental: standard care
COVID-19 cases will receive standard of care [oxygen via masks or ventilators]
Other: standard care
oxygen via masks or ventilators




Primary Outcome Measures :
  1. PCR of SARS-Cov2 RNA [ Time Frame: 14 days ]
    Negative PCR result of SARS-Cov2 RNA in COVID19 patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510233


Contacts
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Contact: Kamal Okasha, PhD 201140403709 okasha70@yahoo.com
Contact: Nahla El-Ashmawy, PhD 201116721982 nahlaelashmawy@yahoo.com

Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Kamal Okasha, PhD Tanta Univesity faculty of Medicine
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Responsible Party: Prof. Dr. Kamal Mohammed Okasha, Vice President, Tanta University
ClinicalTrials.gov Identifier: NCT04510233    
Other Study ID Numbers: IvrInh
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Kamal Mohammed Okasha, Tanta University:
COVID19
Additional relevant MeSH terms:
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Ivermectin
Antiparasitic Agents
Anti-Infective Agents