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Ivermectin In Treatment of COVID 19 Patients

Sponsor
Ministry of Health and Population, Egypt (Other)
Overall Status
Unknown status
CT.gov ID
NCT04425707
Collaborator
(none)
100
Enrollment
1
Location
3
Arms
2.8
Anticipated Duration (Months)
36.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of the patients could not acheive viral clearence with the standard module of care teh idea of introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin had shown a promising results in vitro studies and in limited in vivo studies. this clinical trial may open a new hope for COVID 19 patients as a new and cheap line of treatment

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

the study will compare the effect of ivermectin in comaprison and addition to the standard mode of care for the COVID 19 patients

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Use of Ivermectin In the Treatment of COVID 19 Patients
Actual Study Start Date :
Jun 9, 2020
Anticipated Primary Completion Date :
Jul 1, 2020
Anticipated Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: A ivermectin alone

ivermectin will be administarted alone to COVID 19 patients

Drug: Ivermectin
use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt
Other Names:
  • hydroxychloroquine

    		•
    Experimental: B standard care alone

    standard care will be administarted alone

    Drug: Ivermectin
    use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt
    Other Names:
  • hydroxychloroquine

    		•
    Active Comparator: C ivermectin added to standard of care

    ivermectin will be administarted in adition to standard care

    Drug: Ivermectin
    use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt
    Other Names:
  • hydroxychloroquine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. to evaluate the role of Ivermectin as a line of treatment for COVID 19 [2 months]

      the role of ivermectin in the cure of COVID 19 patients

    Secondary Outcome Measures

    1. To asses the rate of viral clearance in comparison to other treatment protocols. [2 months]

      to compare the results of ivermectin with the standard care

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Asymptomatic mild cases and moderate cases proven to be infected by COVID 19 by viral RNA swap
    Exclusion Criteria:

    • Contraindications for the drug: hypersensitivity.

    • Any medications with possible drug interactions.

    • Severe cases.

    • Any malignant condition.

    • Pregnant females.

    • Breast feeding females.

    • Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to potential severe drug interaction.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 isolation and referal hospitals for COVID 19 patients Cairo Egypt

    Sponsors and Collaborators

    • Ministry of Health and Population, Egypt

    Investigators

    • Study Director: houssam ho masoud, MD, COVID sceintific comittee ministry of health and population

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Ehab kamal, general director of fever hospitals, Ministry of Health and Population, Egypt
    ClinicalTrials.gov Identifier:
    NCT04425707
    Other Study ID Numbers:
    • 14-2020/3
    First Posted:
    Jun 11, 2020
    Last Update Posted:
    Jun 11, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Hydroxychloroquine
    Ivermectin

    Study Results

    No Results Posted as of Jun 11, 2020