CClinicalTrials.gg
Status unknownNCT04510233Updated Aug 12, 2020

Ivermectin Nasal Spray for COVID19 Patients

A Phase 2 interventional study of Ivermectin nasal and Ivermectin oral in Covid19, sponsored by Tanta University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-08-12.

Sponsored by Tanta University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Covid19

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Keywords

  • COVID19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • mild to moderate severity who are confirmed to be positive for SARS COV 2.

Exclusion criteria

Exclusion Criteria:

  • patients with severe form of COVID-19 or those who are on ventilatory support or those with cytokine storm
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Ivermectin nasal spray

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

    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.

    Drug: Ivermectin oral

  • Experimental
    standard care

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

    Other: standard care

Interventions

  • DrugIvermectin nasal

    Ivermectin nasal spray one ml in each nostril two times daily

    Also known as: ivermectin

  • DrugIvermectin oral

    Ivermectin oral (one tablet 6 mg three times daily)

    Also known as: ivermectin

  • Otherstandard care

    oxygen via masks or ventilators

06

What researchers measure

Primary outcomes

  1. PCR of SARS-Cov2 RNA

    Negative PCR result of SARS-Cov2 RNA in COVID19 patients

    Time frame: 14 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04510233
Lead sponsor
Tanta University
Responsible party
Prof. Dr. Kamal Mohammed Okasha (Vice President, Tanta University) — Principal investigator
First posted
Aug 12, 2020
Start date
Sep 2020 (estimated)
Primary completion
Oct 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Aug 12, 2020

Study contacts

Kamal Okasha, PhD
Contact
okasha70@yahoo.com
201140403709
Nahla El-Ashmawy, PhD
Contact
nahlaelashmawy@yahoo.com
201116721982
Kamal Okasha, PhD
principal investigator · Tanta Univesity faculty of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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