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Adverse Effects of Ivermectin Used in Egypt During COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04747678
Recruitment Status : Enrolling by invitation
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
ahmed mohamed esmat fahim mansour, Menoufia University

Study Description
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Brief Summary:
retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt

Condition or disease Intervention/treatment
Covid19 Ivermectin Poisoning Drug Toxicity Drug Side Effect Drug: Ivermectin

Detailed Description:
ivermectin was used in Egypt during the pandemic of covid-19 and it was registered in the MOH protocol that has been published in November 2020 the study will document the adverse effects of many patients used ivermectin as aprophylaxis and as a treatment with multiple dose regimens
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 30 Days
Official Title: Tolerability and Adverse Effects of Using Multiple Doses of Ivermectin in Egypt During Covid 19 Pandemic
Estimated Study Start Date : February 3, 2021
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Groups and Cohorts
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Intervention Details:
  • Drug: Ivermectin
    retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt

Outcome Measures
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Primary Outcome Measures :
  1. all adverse effects will be collected from people used Ivermectin in between September 2020 to December 2020 [ Time Frame: the data will be collected from February 2021 to march 2021 ]
    all data will be collected from retrospective manner as a retrospective study


Secondary Outcome Measures :
  1. all data will be arranged according to time and dose manner [ Time Frame: February to match 2021 ]
    data for each dose will be identified together


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
all healthy and diseased people who used ivermectin the last three months either as a treatment or as a prophylaxis with mention of the doses used and the adverse effects experienced during and after the usage
Criteria

Inclusion Criteria:

  • all people used ivermectin as a treatment or as a prophylactic in covid 19 pandemic in egypt with explained dose

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747678


Locations
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Egypt
Ahmed Mansour
Shibīn Al Kawm, Menoufia, Egypt, 24222
Sponsors and Collaborators
Menoufia University
More Information
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Responsible Party: ahmed mohamed esmat fahim mansour, Principal Investigator, Menoufia University
ClinicalTrials.gov Identifier: NCT04747678    
Other Study ID Numbers: ahmed19782020
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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COVID-19
Poisoning
Drug-Related Side Effects and Adverse Reactions
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Chemically-Induced Disorders
Ivermectin
Antiparasitic Agents
Anti-Infective Agents