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Ivermectin Nasal Spray for COVID19 Patients

Primary Purpose

Covid19

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Ivermectin nasal

Ivermectin oral

standard care

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID19

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Ivermectin nasal spray

Ivermectin oral

standard care

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

PCR of SARS-Cov2 RNA

Negative PCR result of SARS-Cov2 RNA in COVID19 patients

Secondary Outcome Measures

Full Information

NCT ID

NCT04510233

First Posted

August 10, 2020

Last Updated

August 11, 2020

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT04510233

Brief Title

Ivermectin Nasal Spray for COVID19 Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 2020 (Anticipated)

Primary Completion Date

October 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

COVID19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ivermectin nasal spray

Arm Type

Experimental

Arm Description

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

Arm Title

Ivermectin oral

Arm Type

Experimental

Arm Description

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

Arm Title

standard care

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ivermectin nasal

Other Intervention Name(s)

ivermectin

Intervention Description

Ivermectin nasal spray one ml in each nostril two times daily

Intervention Type

Drug

Intervention Name(s)

Ivermectin oral

Other Intervention Name(s)

ivermectin

Intervention Description

Ivermectin oral (one tablet 6 mg three times daily)

Intervention Type

Other

Intervention Name(s)

standard care

Intervention Description

oxygen via masks or ventilators

Primary Outcome Measure Information:

Title

PCR of SARS-Cov2 RNA

Description

Negative PCR result of SARS-Cov2 RNA in COVID19 patients

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kamal Okasha, PhD

Phone

201140403709

okasha70@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Nahla El-Ashmawy, PhD

Phone

201116721982

nahlaelashmawy@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kamal Okasha, PhD

Organizational Affiliation

Tanta Univesity faculty of Medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ivermectin Nasal Spray for COVID19 Patients

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