Ivermectin Treatment Efficacy in Covid-19 High Risk Patients

• Status: Completed
• Trial end date: 2021-10-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Research Centre, Malaysia
• Treatments: Ivermectin

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.