NCT04510233

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_2 covid19

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_2 covid19

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

August 10, 2020

Last Update Submit

August 11, 2020

Conditions

Keywords

COVID19

Outcome Measures

Primary Outcomes (1)

  • PCR of SARS-Cov2 RNA

    Negative PCR result of SARS-Cov2 RNA in COVID19 patients

    14 days

Study Arms (3)

Ivermectin nasal spray

EXPERIMENTAL

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

Drug: Ivermectin nasal

Ivermectin oral

EXPERIMENTAL

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

Drug: Ivermectin oral

standard care

EXPERIMENTAL

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

Other: standard care

Interventions

Ivermectin nasal spray one ml in each nostril two times daily

Also known as: ivermectin
Ivermectin nasal spray

Ivermectin oral (one tablet 6 mg three times daily)

Also known as: ivermectin
Ivermectin oral

oxygen via masks or ventilators

standard care

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Interventions

IvermectinStandard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Kamal Okasha, PhD

    Tanta Univesity faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamal Okasha, PhD

CONTACT

Nahla El-Ashmawy, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 12, 2020

Study Start

September 1, 2020

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share