Ivermectin Nasal Spray for COVID19 Patients

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04510233
• Other study ID #: IvrInh
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2020
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: Tanta University
• Contact: Kamal Okasha, PhD
• Phone: 201140403709
• Email: okasha70[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Ivermectin nasal
Ivermectin nasal spray one ml in each nostril two times daily
• Ivermectin oral
Ivermectin oral (one tablet 6 mg three times daily)

Other:
• standard care
oxygen via masks or ventilators

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCR of SARS-Cov2 RNA	Negative PCR result of SARS-Cov2 RNA in COVID19 patients	14 days