Status:
COMPLETED
Ivermectin Treatment Efficacy in Covid-19 High Risk Patients
Lead Sponsor:
Clinical Research Centre, Malaysia
Conditions:
COVID-19
Eligibility:
All Genders
50-100 years
Phase:
PHASE3
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 ca...
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 requirin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
- Other patients judged ineligible by the principal investigator or sub-investigator.
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04920942
Start Date
May 31 2021
End Date
October 31 2021
Last Update
June 1 2023
Active Locations (21)
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1
Sultanah Aminah Hospital
Johor Bahru, Johor, Malaysia, 80000
2
Sultanah Bahiyah Hospital
Alor Star, Kadah, Malaysia, 05460
3
Sultan Abdul Halim Hospital
Sungai Petani, Kedah, Malaysia, 08000
4
Hospital Raja Permaisuri Bainun, Ipoh
Ipoh, Perak, Malaysia, 30450