Ivermectin Nasal Spray for COVID19 Patients

Phase 2

• Conditions: Covid19
• Interventions: Drug: Ivermectin nasal; Drug: Ivermectin oral; Other: standard care

• Registration Number: NCT04510233
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Study First Posted: 2020-08-12
• Last Update Posted: 2020-08-12
• Study Start: 2020-09
• Primary Completion: 2020-10
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivermectin nasal spray	Ivermectin nasal	Ivermectin administered as nasal spray (one ml in each nostril two times daily)
Ivermectin oral	Ivermectin oral	Ivermectin administered orally (one tablet 6 mg three times daily) for 72 hours plus the standard care of COVID-19 cases.
standard care	standard care	COVID-19 cases will receive standard of care \[oxygen via masks or ventilators\]

Primary Outcome Measures

Name	Time	Method
PCR of SARS-Cov2 RNA	14 days	Negative PCR result of SARS-Cov2 RNA in COVID19 patients