Ivermectin Treatment Efficacy in Covid-19 High Risk Patients

NCT04920942 | Completed Phase 3 DMC

• 1 other identifier: I-TECH21
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 21

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.

Conditions

COVID-19

Keywords

Ivermectin; COVID-19

Outcome Measures

Primary Outcomes (2)

• Number of Patients who Progressed to Severe Disease (Clinical stage 4 or 5)

  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

  Within 28 days since administered Ivermectin

• Time Required for Patients on Treatment Arm to Progressed to Severe Disease (Clinical stage 4 or 5)

  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

  Within 28 days since administered Ivermectin

Secondary Outcomes (12)

• Mortality

  Through study completion, an average of 28 days

• Number of Participants with Complete Resolution of Symptoms by day 5 of Enrolment

  5 days since time of recruitment

• Chest Radiograph Changes Pertaining to COVID-19 by Day 5 of Enrolment

  5 days since time of recruitment

• Changes in Serum Absolute Lymphocyte Count

  From starting to the end of ivermectin therapy (0 to end of 5th day)

• Changes in Serum Absolute Neutrophil Counts

  From starting to the end of ivermectin therapy (0 to end of 5th day)

Study Arms (2)

Treatment group

EXPERIMENTAL

Ivermectin 0.4mg/kg/day for 5 days + standard-of-care

Drug: Ivermectin 0.4mg/kg/day for 5 days

Control group

NO INTERVENTION

Standard-of-care only

Interventions

Ivermectin 0.4mg/kg/day for 5 days DRUG

Ivermectin 0.4mg/kg/day for 5 days with standard-of-care

Treatment group

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• RT-PCR or antigen test confirmed COVID-19 cases
• Aged 50 years and above,with at least one co-morbidities\*
• Within the first 7 days of illness (from symptom onset)
• Mild to moderate clinical severity

You may not qualify if:

• Asymptomatic stage 1 patients
• Patients with SpO2 less than 95% at rest. (unless it is an expected baseline SpO2 due to preexisting disease, eg. COAD or pulmonary fibrosis)
• Patients who need oxygen supplements
• Patients with concomitant bacterial, fungal, parasitic or other viral infections prior to enrollment.
• Patients with severe hepatic impairment (\>Grade 3: ALT \>10 times of upper normal limit)
• Malabsorptionsyndromeorotherclinicallysignificantgastrointestinaldisease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
• Pregnant or nursing women.
• 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.
• Male patient who has female partner of reproductive age and he cannot agree to use contraception from the start of ivermectin treatment till 7 days after treatment.
• Patients receiving chemotherapy
• 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.
• Patients in whom this episode of infection is a recurrence or reinfection of COVID- 19.
• Patients who have previously received ivermectin.
• Patient receiving warfarin or any medications known to interact with ivermectin.
• Acute medical or surgical emergency (eg. DKA/MI/stroke).

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead

Study Sites (21)

Sultanah Aminah Hospital

Johor Bahru, Johor, 80000, Malaysia

Location

Sultanah Bahiyah Hospital

Alor Star, Kadah, 05460, Malaysia

Location

Sultan Abdul Halim Hospital

Sungai Petani, Kedah, 08000, Malaysia

Location

Hospital Raja Permaisuri Bainun, Ipoh

Ipoh, Perak, 30450, Malaysia

Location

Taiping Hospital

Taiping, Perak, 34000, Malaysia

Location

Tuanku Fauziah Hospital

Kangar, Perlis, 01000, Malaysia

Location

Pulau Pinang Hospital

George Town, Pulau Pinang, 10990, Malaysia

Location

Lahad Datu Hospital

Tawau, Sabah, 911000, Malaysia

Location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

Sungai Buloh Hospital

Shah Alam, Selangor, 47000, Malaysia

Location

Permai Hospital

Kempas, Malaysia

Location

Kepala Batas Hospital

Kepala Batas, Malaysia

Location

Kuala Kangsar Hospital

Kuala Kangsar, Malaysia

Location

Kuala Lumpur Hospital

Kuala Lumpur, 50586, Malaysia

Location

Sultanah Nur Zahirah

Kuala Terengganu, Malaysia

Location

Melaka Hospital

Malacca, 754000, Malaysia

Location

Putrajaya Hospital

Putrajaya, Malaysia

Location

Duchess of Kent Hospital

Sandakan, Malaysia

Location

Low Risk COVID-19 Quarantine & Treatment Centre - Malaysia Agro Exposition Park Serdang (MAEPS)

Serdang, Malaysia

Location

Sg Siput Hospital

Sungai Siput, Malaysia

Location

Tumpat Hospital

Tumpat, Malaysia

Location

Related Publications (1)

• Lim SCL, Hor CP, Tay KH, Mat Jelani A, Tan WH, Ker HB, Chow TS, Zaid M, Cheah WK, Lim HH, Khalid KE, Cheng JT, Mohd Unit H, An N, Nasruddin AB, Low LL, Khoo SWR, Loh JH, Zaidan NZ, Ab Wahab S, Song LH, Koh HM, King TL, Lai NM, Chidambaram SK, Peariasamy KM; I-TECH Study Group. Efficacy of Ivermectin Treatment on Disease Progression Among Adults With Mild to Moderate COVID-19 and Comorbidities: The I-TECH Randomized Clinical Trial. JAMA Intern Med. 2022 Apr 1;182(4):426-435. doi: 10.1001/jamainternmed.2022.0189.

  PMID: 35179551 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• CHEE L LIM, MRCP

  Ministry of Health, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 10, 2021
• Study Start: May 31, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: June 1, 2023

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (21)