Ivermectin Nasal Spray for COVID19 Patients

Tanta University

Status and phase: Unknown; Phase 2

Conditions: Covid19

Treatments: Drug: Ivermectin oral; Other: standard care; Drug: Ivermectin nasal

Study type: Interventional

Funder types: Other

Identifiers

NCT04510233

IvrInh

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Ivermectin nasal spray

Experimental group

Description:

Ivermectin administered as nasal spray (one ml in each nostril two times daily)

Treatment:

Drug: Ivermectin nasal

Ivermectin oral

Experimental group

Description:

Ivermectin administered orally (one tablet 6 mg three times daily) for 72 hours plus the standard care of COVID-19 cases.

Treatment:

Drug: Ivermectin oral

standard care

Experimental group

Description:

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

Treatment:

Other: standard care