Ivermectin Nasal Spray for COVID19 Patients

• ClinicalTrials.gov Identifier: NCT04510233
• Recruitment Status: Unknown
• First Posted: August 12, 2020
• Last Update Posted: August 12, 2020
• Sponsor: Tanta University
• Information provided by (Responsible Party): Prof. Dr. Kamal Mohammed Okasha, Tanta University

Tracking Information

• First Submitted Date: August 10, 2020
• First Posted Date: August 12, 2020
• Last Update Posted Date: August 12, 2020
• Estimated Study Start Date: September 2020
• Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ivermectin Nasal Spray for COVID19 Patients
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Covid19

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 11, 2020): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04510233
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Prof. Dr. Kamal Mohammed Okasha, Tanta University
• Original Responsible Party: Same as current
• Current Study Sponsor: Tanta University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kamal Okasha, PhD; Tanta Univesity faculty of Medicine

• PRS Account: Tanta University
• Verification Date: August 2020