Ivermectin Role in Covid-19 Clinical Trial (IRICT)
Primary Purpose
Covid19
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
ivermectin
hydroxychloroquine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
- Agrees to the collection of OP swabs and venous blood per protocol.
- Male or non-pregnant female adult ≥18 years of age at time of enrollment.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other
- Severe cases according to WHO definition.
Exclusion Criteria:
- ALT/AST > 5 times the upper limit of normal.
- Mortality within 12 hours of admission.
- Pregnancy.
- Anticipated transfer to another hospital within 24 hours.
- Allergy to any study medication commercial or public health assay in any specimen prior to randomization.
- Mechanically ventilated on admission
Sites / Locations
- Shebin-Elkom teaching hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ivermectin
hydroxychloroquine
Placebo
Arm Description
ivermectin was given as a total daily dose of 36 mg on days 0, 3, 6. The daily dose was divided into 3 equal doses of 12 mg (2 tablets) every 8 hours
hydroxychloroquine was given as 200 mg (one tablet) every 12 hours for 5 days
Unlabelled standard treatment according to the clinical condition of patients
Outcomes
Primary Outcome Measures
Reduction in the WHO ordinal scale of clinical status by at least two points
The ordinal scale consists of 7 points, the maximum score is 7 which indicates a worst outcome, while the minimum score is 1 which indicates a better outcome
Time to discharge
time to discharge to home after no more need for hospitalization
Secondary Outcome Measures
Mortality
All-causes mortality
Full Information
NCT ID
NCT04746365
First Posted
February 6, 2021
Last Updated
February 8, 2021
Sponsor
Elaraby Hospital
Collaborators
Shebin El-Kom Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04746365
Brief Title
Ivermectin Role in Covid-19 Clinical Trial
Acronym
IRICT
Official Title
Ivermectin Role in Severe Covid-19 Treatment; a Double-blinded, Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
February 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Elaraby Hospital
Collaborators
Shebin El-Kom Teaching Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Because ivermectin is being used to treat COVID-19 with insufficient evidence, the investigator conducted a randomized clinical trial to investigate the efficacy and safety of ivermectin in comparison to hydroxychloroquine and placebo in severe COVID-19 patients. The study was conducted in Shebin-Elkom teaching hospital and recruited patients from December 6, 2020, to January 31, 2021.
Detailed Description
This study is an adaptive, randomized, double-blinded, controlled trial to evaluate the safety and efficacy of therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a single-center trial that will be conducted in Shebin Elkom teaching hospital. The study will be a series of 3-arm comparisons between two different investigational therapeutic agents (Ivermectin and Hydroxychloroquine) and a placebo. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. Because of the possibility that background standards of supportive care may evolve/improve over time as more is learned about the successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized participants. An independent data and safety monitoring board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blinded, controlled clinical trial
Masking
ParticipantCare Provider
Masking Description
Unlabelled tablets were prepared for each patient in a special envelope in a time-based manner in the central pharmacy
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ivermectin
Arm Type
Experimental
Arm Description
ivermectin was given as a total daily dose of 36 mg on days 0, 3, 6. The daily dose was divided into 3 equal doses of 12 mg (2 tablets) every 8 hours
Arm Title
hydroxychloroquine
Arm Type
Experimental
Arm Description
hydroxychloroquine was given as 200 mg (one tablet) every 12 hours for 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Unlabelled standard treatment according to the clinical condition of patients
Intervention Type
Drug
Intervention Name(s)
ivermectin
Intervention Description
ivermectin is anthelmintic
Intervention Type
Drug
Intervention Name(s)
hydroxychloroquine
Intervention Description
hydroxychloroquine is antimalarial.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Standard treatments
Primary Outcome Measure Information:
Title
Reduction in the WHO ordinal scale of clinical status by at least two points
Description
The ordinal scale consists of 7 points, the maximum score is 7 which indicates a worst outcome, while the minimum score is 1 which indicates a better outcome
Time Frame
14 days
Title
Time to discharge
Description
time to discharge to home after no more need for hospitalization
Time Frame
within 14 days
Secondary Outcome Measure Information:
Title
Mortality
Description
All-causes mortality
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Grade 3 and 4 adverse events and serious adverse events
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures.
Agrees to the collection of OP swabs and venous blood per protocol.
Male or non-pregnant female adult ≥18 years of age at time of enrollment.
Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other
Severe cases according to WHO definition.
Exclusion Criteria:
ALT/AST > 5 times the upper limit of normal.
Mortality within 12 hours of admission.
Pregnancy.
Anticipated transfer to another hospital within 24 hours.
Allergy to any study medication commercial or public health assay in any specimen prior to randomization.
Mechanically ventilated on admission
Facility Information:
Facility Name
Shebin-Elkom teaching hospital
City
Shibīn Al Kawm
State/Province
Menoufia
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
35788169
Citation
Elshafie AH, Elsawah HK, Hammad M, Sweed EM, Seif AS, Abdel Ghaffar MM, Goda FM, Mosalam EM, Abdallah MS. Ivermectin role in COVID-19 treatment (IRICT): single-center, adaptive, randomized, double-blind, placebo-controlled, clinical trial. Expert Rev Anti Infect Ther. 2022 Oct;20(10):1341-1350. doi: 10.1080/14787210.2022.2098113. Epub 2022 Jul 12.
Results Reference
derived
Learn more about this trial
Ivermectin Role in Covid-19 Clinical Trial
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