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Ivermectin In Treatment of COVID 19 Patients

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ClinicalTrials.gov Identifier: NCT04425707
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Ehab kamal, Ministry of Health and Population, Egypt

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
Covid19 Drug: Ivermectin Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 9, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: hydroxychloroquine




Primary Outcome Measures :
  1. to evaluate the role of Ivermectin as a line of treatment for COVID 19 [ Time Frame: 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. [ Time Frame: 2 months ]
    to compare the results of ivermectin with the standard care



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04425707


Contacts
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Contact: ehab ah kamal, MD 01006162663 ehabkamal2011@hotmail.com
Contact: noha mo asem, MD

Locations
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Egypt
isolation and referal hospitals for COVID 19 patients Recruiting
Cairo, Egypt
Contact: ehab ah kamal, MD    01006162663      
Sponsors and Collaborators
Ministry of Health and Population, Egypt
Investigators
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Study Director: houssam ho masoud, MD COVID sceintific comittee ministry of health and population
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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: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydroxychloroquine
Ivermectin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents