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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

Tracking Information
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
 (submitted: August 11, 2020)		 PCR of SARS-Cov2 RNA [ Time Frame: 14 days ]
Negative PCR result of SARS-Cov2 RNA in COVID19 patients
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.
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
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Ivermectin nasal
    Ivermectin nasal spray one ml in each nostril two times daily
    Other Name: ivermectin
  • Drug: Ivermectin oral
    Ivermectin oral (one tablet 6 mg three times daily)
    Other Name: ivermectin
  • Other: standard care
    oxygen via masks or ventilators
Study Arms  ICMJE
  • Experimental: Ivermectin nasal spray
    Ivermectin administered as nasal spray (one ml in each nostril two times daily)
    Intervention: Drug: Ivermectin nasal
  • Experimental: Ivermectin oral
    Ivermectin administered orally (one tablet 6 mg three times daily) for 72 hours plus the standard care of COVID-19 cases.
    Intervention: Drug: Ivermectin oral
  • Experimental: standard care
    COVID-19 cases will receive standard of care [oxygen via masks or ventilators]
    Intervention: Other: standard care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 11, 2020)		 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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kamal Okasha, PhD 201140403709 okasha70@yahoo.com
Contact: Nahla El-Ashmawy, PhD 201116721982 nahlaelashmawy@yahoo.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Dr. Kamal Mohammed Okasha, Tanta University
Study Sponsor  ICMJE Tanta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kamal Okasha, PhD Tanta Univesity faculty of Medicine
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