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History of Changes for Study: NCT04920942
Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH)
Latest version (submitted November 24, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 8, 2021 None (earliest Version on record)
2 June 9, 2021 Outcome Measures and Study Status
3 June 16, 2021 Recruitment Status, Outcome Measures, Study Status, Contacts/Locations, Eligibility, Study Description and Study Identification
4 November 3, 2021 Recruitment Status, Study Status, Contacts/Locations, Eligibility, Study Design and Study Description
5 November 24, 2021 Study Status, Contacts/Locations, Eligibility and Study Design
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Changes (Merged) for Study: NCT04920942
June 16, 2021 (v3) -- November 3, 2021 (v4)

Changes in: Study Status, Study Description, Study Design, Eligibility and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: I-TECH21
Brief Title: Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH)
Official Title: Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH Study): A Multicenter Open-label Randomized Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2021 November 2021
Overall Status: Recruiting Completed
Study Start: June 1, 2021
Primary Completion: December 1, 2021 [Anticipated] October 9, 2021 [Actual]
Study Completion: January 1, 2022 [Anticipated] October 9, 2021 [Actual]
First Submitted: May 31, 2021
First Submitted that
Met QC Criteria:
June 8, 2021
First Posted: June 10, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
June 16, 2021 November 3, 2021
Last Update Posted: June 21 November 10, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Clinical Research Centre, Malaysia
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is a multicenter study, which is aimed to investigate the efficacy of the Ivermectine 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.
Detailed Description:

Objectives

Primary Objective:

To assess the effectiveness of Ivermectin in preventing progression of Covid-19 to severe disease (clinical stage 4 or 5), which is defined as severe pneumonia requiring oxygen supplement or critically ill requiring intensive care.

Secondary Objectives:

  1. To assess the efficacy of Ivermectin in reducing mortality rate among high risk COVID-19 patients.
  2. To compare difference in resolution of symptoms, chest radiograph, laboratory investigations, ICU admission, mechanical ventilation and length of hospital stay.

Methodology Study Type and Design 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 are met.

Rationale of ivermectin dose and duration in this study:

The dose regimens used in various randomized control trials with positive results range from 0.2mg/kg single dose to 0.6mg/kg/day for 5 days 10-15. PK/PD studies have shown that the antiviral effect of Ivermectin is dose dependent 9,15. As SARS-CoV-2 viral load peaks during the first week of illness and may prolong in severe disease 18, we believe a high dose of ivermectin 0.4mg/kg/day for 5 days would be reasonable and safe to achieve our study objectives.

Standard of care:

Based on the current Malaysian guidelines, standard of care for mild to moderate Covid-19 patients includes isolation, infection control, close monitoring (clinical findings, laboratory tests, chest imaging) and symptomatic treatment.

Study Population The population for this clinical trial will be comprised of adults with a polymerase chain reaction (PCR) confirmed diagnosis of COVID-19 admitted to any of the participating hospitals. Participants who

  1. Treatment group: Ivermectin 0.4mg/kg/day for 5 days + standard-of-care
  2. Control group: Standard-of-care only

Patients who fulfil the inclusion criteria and do not meet the exclusion criteria will be enrolled. Identification of eligible participants will be done prospectively at each study site.

Sample Size Sample size calculation was performed using ScalexProp Version 1.0.2 (Naing, 2016). The calculation is based on superiority trial design and the primary outcome measure of the need to have supplemental oxygen therapy during the hospital admission. We regard a 9% difference between intervention arm and control arm as a clinically important outcome. Based on local data, 17.5% of COVID-19 aged 50 years and above, with stage 2 and 3 disease and comorbidity, progressed to severe disease 3. The need of supplemental oxygen therapy is expected to be about 8.8% in intervention arm and 17.5% in control arm. With a margin of superiority set to be 1%, the study requires 231 patients for each arm or in total 462 patients. Considering potential dropouts during the trial, we would require up to 500 patients or 250 patients each arm. The sample size provides a level of significance at 5% with 80% power (2-sided test).

Open or close this module Conditions
Conditions: COVID-19
Keywords: Ivermectin
COVID-19
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
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
Number of Arms: 2
Masking: Single (Investigator)
Allocation: Randomized
Enrollment: 500 [ Anticipated Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age: 100 Years
Sex: All
Gender Based:
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 or women planning pregnancy 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. Patients who are not able to provide written consent. Acute medical or surgical emergency (eg. DKA/MI/stroke).
  16. Other patients judged ineligible by the principal investigator or sub-investigator.
Open or close this module Contacts/Locations
Central Contact Person: STEVEN CL LIM, MRCP
Telephone: 60133620081
Email: stevenlimcl@gmail.com
Central Contact Backup: Mohan D Pathmanathan, MD
Telephone: 60129190794
Email: mohan.pathmanathan@gmail.com
Study Officials: CHEE L LIM, MRCP
Principal Investigator
Ministry of Health, Malaysia
Locations: Malaysia
Kepala Batas Hospital
Kepala Batas, Malaysia
Malaysia
Kuala Lumpur Hospital
[Recruiting]
Kuala Lumpur, Malaysia, 50586
Contact:Contact: Khairil E Khalid, MRCP
Kuala Lumpur Hospital
Kuala Lumpur, Malaysia, 50586
Sultanah Nur Zahirah
Kuala Terengganu, Malaysia
Melaka Hospital
[Recruiting]
Melaka, Malaysia, 754000
Contact:Contact: Nor Zaila Zaidan, MRCP
Melaka Hospital
Melaka, Malaysia, 754000
Putrajaya Hospital
Putrajaya, Malaysia
Duchess of Kent Hospital
Sandakan, Malaysia
Low Risk COVID-19 Quarantine & Treatment Centre - Malaysia Agro Exposition Park Serdang (MAEPS)
Serdang, Malaysia
Tumpat Hospital
Tumpat, Malaysia
Malaysia, Johor
Sultanah Aminah Hospital
[Recruiting]
Johor Bahru, Johor, Malaysia, 80000
Contact:Contact: Masliza Zaid, MRCP
Malaysia, Kadah
Sultanah Bahiyah Hospital
[Recruiting]
Alor Setar, Kadah, Malaysia, 05460
Contact:Contact: Lee L Low, MRCP
Malaysia, Kedah
Sultan Abdul Halim Hospital
[Recruiting]
Sungai Petani, Kedah, Malaysia, 08000
Contact:Contact: Noralfazita An@Amran, MRCP
Malaysia, Perak
Hospital Raja Permaisuri Bainun, Ipoh
[Recruiting]
Ipoh, Perak, Malaysia, 30450
Contact:Contact: Hong B Ker, MRCP
Taiping Hospital
[Recruiting]
Taiping, Perak, Malaysia, 34000
Contact:Contact: Wooi K Cheah, MRCP
Taiping Hospital
Taiping, Perak, Malaysia, 34000
Malaysia, Perlis
Tuanku Fauziah Hospital
[Recruiting]
Kangar, Perlis, Malaysia, 01000
Contact:Contact: Suhaila Ab Wahab, MRCP
Tuanku Fauziah Hospital
Kangar, Perlis, Malaysia, 01000
Malaysia, Pulau Pinang
Pulau Pinang Hospital
[Recruiting]
George Town, Pulau Pinang, Malaysia, 10990
Contact:Contact: Ting S Chow, MRCP
Malaysia, Sabah
Lahad Datu Hospital
[Recruiting]
Tawau, Sabah, Malaysia, 911000
Contact:Contact: Song W Khoo, MRCP
Lahad Datu Hospital
Tawau, Sabah, Malaysia, 911000
Malaysia, Sarawak
Sarawak General Hospital
[Recruiting]
Kuching, Sarawak, Malaysia, 93586
Contact:Contact: Han H Lim, MRCP
Sarawak General Hospital
Kuching, Sarawak, Malaysia, 93586
Malaysia, Selangor
Sungai Buloh Hospital
[Recruiting]
Shah Alam, Selangor, Malaysia, 47000
Contact:Contact: Kim H Tay, MRCP
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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