Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection (IDRA-COVID19)

Mahidol University

Status and phase: Unknown; Phase 4

Conditions: Asymptomatic Infections; SARS-CoV2 Infection

Treatments: Drug: Ivermectin Pill; Drug: Combined ART/hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT04435587

323/2563 (IRB3)

Details and patient eligibility

About

This is an open label randomised controlled study of oral ivermectin (600 mcg/kg/d* 3 day) versus combined of hydroxychloroquine plus darunavir/ ritonavir for 5 days treatment among asymptomatic carrier of SAR-CoV2 adult Thai population. Both study treatment regimens will have oral zinc sulfate combination treatment ( 200mg. twice daily). Outcomes include safety and duration of detectable of SAR-CoV2 in nasopharyngeal/ throat (NP) swab by polymerase chain reaction amplification (PCR) after treatment. 40-50 patients in each treatment arm is planned, with an interim analysis when approximately 50% of cases is enrolled.

Full description

• Study procedure will be carried out after informed consent is obtained.
• Baseline physical exam and laboratory investigations will be performed.
• Eligible patients will be randomized to one of the two treatment arms.
• Symptoms and signs will be monitored daily.
• NP swab will be done at day5-7, and prior to discharge.
• Complete blood counts, blood chemistries, electrocardiography will be performed for adverse event monitoring within 5 days after end of study drugs' administration.
• Patients will be discharged at 2- 4 weeks after hospitalization, according to PCR results.
• There will be 1-2 follow up visit at out patient clinic for NP swab (patients with +ve last NP swab before discharge), and blood tests.
• Additional 5-8 ml. of EDTA blood will be taken at baseline and weekly for antibody detection.
• Interim analysis of both safety and efficacy will be performed when approximately 50% of enrollment is achieved.
• Intention to treat analysis is planned at the completion of enrollment.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SAR-CoV2 detected by PCR from NP swab
• Asymptomatic or upper respiratory symptoms such as runny noses
• No history of fever or oral Temp <37.8 degree celsius
• informed consent obtained

Exclusion criteria

• Fever or respiratory rate >24/minute or oxygen saturation at room air< 94%
• Any serious co-morbidity such as chronic lung disease, chronic kidney disease, cardiovascular diseases, arrythmia, diabetes mellitus with HbA1C > 8%, chronic liver disease, lymphocyte count <1,000cell/cu.mm.
• History of ivermectin or any of the study drug allergy.
• Concomitant medication with potential drug interaction with any of the study drugs such as alfuzosin, colchicine, ergot derivatives, cisapride, simvastatin and rifampicin
• Pregnant or lactating woman

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

ivermectin

Experimental group

Description:

Combination of 1. oral ivermectin 600 mcg/kg/day once daily for 3 days 2. Zinc sulfate (100mg/tab) 2 tab every 12 hours for 3 days

Treatment:

Drug: Ivermectin Pill

ART/hydroxychloroquine

Active Comparator group

Description:

Combination of 1. Day1 hydroxychloroquine 400mg bid, then 200mg bid on Day 2-5 2. Darunavir/ritonavir (400/100mg) every 12 hours for 5 days 3. Zinc sulfate (100/tab) 2 tab every 12 hours for 5 days

Treatment:

Drug: Combined ART/hydroxychloroquine