Ivermectin Role in Covid-19 Clinical Trial (IRICT)

Ivermectin Role in Severe Covid-19 Treatment; a Double-blinded, Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: ivermectin; Drug: hydroxychloroquine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt
      • Shebin-Elkom teaching hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
2. Understands and agrees to comply with planned study procedures.
3. Agrees to the collection of OP swabs and venous blood per protocol.
4. Male or non-pregnant female adult ≥18 years of age at time of enrollment.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other
6. Severe cases according to WHO definition.

Exclusion Criteria:

1. ALT/AST > 5 times the upper limit of normal.
2. Mortality within 12 hours of admission.
3. Pregnancy.
4. Anticipated transfer to another hospital within 24 hours.
5. Allergy to any study medication commercial or public health assay in any specimen prior to randomization.
6. Mechanically ventilated on admission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ivermectin; 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	Drug: ivermectin; ivermectin is anthelmintic
EXPERIMENTAL: hydroxychloroquine; hydroxychloroquine was given as 200 mg (one tablet) every 12 hours for 5 days	Drug: hydroxychloroquine; hydroxychloroquine is antimalarial.
PLACEBO_COMPARATOR: Placebo; Unlabelled standard treatment according to the clinical condition of patients	Drug: Placebo; Standard treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	14 days
Time to discharge	time to discharge to home after no more need for hospitalization	within 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All-causes mortality	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Grade 3 and 4 adverse events and serious adverse events	14 days

Collaborators and Investigators

• Sponsor: Elaraby Hospital
• Collaborators: Shebin El-Kom Teaching Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2020
• Primary Completion (ACTUAL): January 31, 2021
• Study Completion (ACTUAL): February 6, 2021

Study Registration Dates

• First Submitted: February 6, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (ACTUAL): February 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Ivermectin; Hydroxychloroquine
• Other Study ID Numbers: 1029076; 2101001 (REGISTRY: IRICT trial)

Drug and device information, study documents

• 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