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Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH)

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ClinicalTrials.gov Identifier: NCT04920942
Recruitment Status : Completed
First Posted : June 10, 2021
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Clinical Research Centre, Malaysia

Brief Summary:
This is a multicenter study, which is aimed to investigate the efficacy of the Ivermectin drug in high risk COVID-19 patients. This study will compare Ivermectin treatment efficacy with standard of care alone. Target cohort is mild to moderate symptomatic Covid-19 (Stage 2-3), high risk patients aged 50 years and above with comorbidity, who presented to hospitals within first 7 days of illness.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Ivermectin 0.4mg/kg/day for 5 days Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multicenter, open-label, randomized controlled clinical trial involving COVID-19 designated hospitals in Malaysia. Patients are randomized at ratio of 1:1 to groups receiving ivermectin for 5 days plus standard-of-care versus standard-of-care only. Patients will be assigned to stratified randomized treatments based on a central, computer-generated randomization scheme coordinated by an independent third party. Based on national guidelines, all high risk COVID-19 patients will be admitted to hospitals, and allow discharge once criteria met
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH Study): A Multicenter Open-label Randomized Controlled Trial
Actual Study Start Date : June 1, 2021
Actual Primary Completion Date : October 9, 2021
Actual Study Completion Date : October 9, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Treatment group
Ivermectin 0.4mg/kg/day for 5 days + standard-of-care
Drug: Ivermectin 0.4mg/kg/day for 5 days
Ivermectin 0.4mg/kg/day for 5 days with standard-of-care

No Intervention: Control group
Standard-of-care only



Primary Outcome Measures :
  1. Number of Patients who Progressed to Severe Disease (Clinical stage 4 or 5) [ Time Frame: Within 28 days since administered Ivermectin ]
    The number of patients recruited who clinically deteriorated to clinical stage 4 or 5. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable

  2. Time Required for Patients on Treatment Arm to Progressed to Severe Disease (Clinical stage 4 or 5) [ Time Frame: Within 28 days since administered Ivermectin ]
    The time duration for patients in the treatment arm to deteriorated to clinical stage 4 or 5. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Through study completion, an average of 28 days ]
    The number of died patients were evaluated in study and control groups. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable

  2. Number of Participants with Complete Resolution of Symptoms by day 5 of Enrolment [ Time Frame: 5 days since time of recruitment ]
    The total numbers of patients with complete resolution of symptoms were evaluated in study and control groups. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable

  3. Chest Radiograph Changes Pertaining to COVID-19 by Day 5 of Enrolment [ Time Frame: 5 days since time of recruitment ]
    Radiological Changes Pertaining to COVID-19 is recorded at day 1 of enrolment and compared with day 5 of enrolment. The differences between two study arms will be assessed via chi-square test. Estimates will be reported in proportions and 95% confidence intervals, together with their corresponding p-values. A logistic regression will also be performed, to enable estimates to be presented in the form of odds ratio and its corresponding 95% confidence interval, potentially adjusting for clinically relevant and statistically significant variable

  4. Changes in Serum Absolute Lymphocyte Count [ Time Frame: From starting to the end of ivermectin therapy (0 to end of 5th day) ]
    For changes in Serum Absolute Lymphocyte counts (cell/mm3), baseline values, value at each post baseline analysis, changes from baseline at each post baseline analysis will be provided descriptively by each study arm either in mean and SD or median and interquartile range.

  5. Changes in Serum Absolute Neutrophil Counts [ Time Frame: From starting to the end of ivermectin therapy (0 to end of 5th day) ]
    For changes in Serum Absolute Neutrophil counts (cell/mm3), baseline values, value at each post baseline analysis, changes from baseline at each post baseline analysis will be provided descriptively by each study arm either in mean and SD or median and interquartile range.

  6. Changes in Serum C-Reative Protein (CRP) [ Time Frame: From starting to the end of ivermectin therapy (0 to end of 5th day) ]
    For changes in Serum C-Reative Protein (mg/L), baseline values, value at each post baseline analysis, changes from baseline at each post baseline analysis will be provided descriptively by each study arm either in mean and SD or median and interquartile range.

  7. Changes in Serum Creatinine [ Time Frame: From starting to the end of ivermectin therapy (0 to end of 5th day) ]
    For changes in Serum Creatinine (micro mol/L), baseline values, value at each post baseline analysis, changes from baseline at each post baseline analysis will be provided descriptively by each study arm either in mean and SD or median and interquartile range.

  8. Changes in Serum Alanine Aminotransferase (ALT) [ Time Frame: From starting to the end of ivermectin therapy (0 to end of 5th day) ]
    For changes in Serum Alanine Aminotransferase (U/L), baseline values, value at each post baseline analysis, changes from baseline at each post baseline analysis will be provided descriptively by each study arm either in mean and SD or median and interquartile range.

  9. Numbers of Participants Admitted to the Intensive Care Unit [ Time Frame: Through study completion, an average of 28 days ]
    The number of patients admitted to the intensive care unit were evaluated in study and control groups

  10. Numbers of Participants who Require Mechanical Ventilation [ Time Frame: Through study completion, an average of 28 days ]
    The number of patients who require mechanical ventilation were evaluated in study and control groups

  11. The Length of Hospital Stay (in Calendar days) [ Time Frame: Through study completion, an average of 28 days ]
    The average number of hospitalisation required for both groups.

  12. Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: From the 6th day of study to the 28th day of study ]
    Adverse effects of ivermectin



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. RT-PCR confirmed COVID-19 cases
  2. Aged 50 years and above,with at least one co-morbidities*
  3. Within the first 7 days of illness (from symptom onset)
  4. Mild to moderate clinical severity

Exclusion Criteria:

  1. Asymptomatic stage 1 patients
  2. Patients with SpO2 less than 95% at rest. (unless it is an expected baseline SpO2 due to preexisting disease, eg. COAD or pulmonary fibrosis)
  3. Patients who need oxygen supplements
  4. Patients with concomitant bacterial, fungal, parasitic or other viral infections prior to enrollment.
  5. Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit)
  6. Malabsorptionsyndromeorotherclinicallysignificantgastrointestinaldisease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
  7. Pregnant or nursing women.
  8. Female patients of reproductive age who cannot consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of ivermectin administration to 7 days after the end of ivermectin administration
  9. Male patients whose partner cannot agree to use the contraception method described in (8) above
  10. Patients receiving chemotherapy
  11. Patients who received interferon or drugs with reported antiviral activity against COVID-19 (favipiravir, hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, remdesivir) in the past 7 days before enrollment.
  12. Patients in whom this episode of infection is a recurrence or reinfection of COVID- 19.
  13. Patients who have previously received ivermectin.
  14. Patient receiving warfarin or any medications known to interact with ivermectin.
  15. Acute medical or surgical emergency (eg. DKA/MI/stroke).
  16. Other patients judged ineligible by the principal investigator or sub-investigator.

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): NCT04920942


Locations
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Sponsors and Collaborators
Clinical Research Centre, Malaysia
Investigators
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Principal Investigator: CHEE L LIM, MRCP Ministry of Health, Malaysia
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Responsible Party: Clinical Research Centre, Malaysia
ClinicalTrials.gov Identifier: NCT04920942    
Other Study ID Numbers: I-TECH21
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Clinical Research Centre, Malaysia:
Ivermectin
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents