Asymptomatic Infections, SARS-CoV2 Infection
Conditions
Keywords
ivermectin, hydroxychloroquine/darunavir/ritonavir, SAR-CoV2, asymptomatic infection, zinc sulfate
Brief summary
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.
Detailed 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.
Interventions
DRUGIvermectin Pill
3 days of once daily oral ivermectin 600mcg/kg/d
DRUGCombined ART/hydroxychloroquine
1. Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid 2. Darunavir/ritonavir (400/100mg) q 12 hours for 5 days
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
PCR for SAR-CoV2 detection will be performed by technician without knowledge of treatment arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rates | after first dose until day 28 of follow up | Comparison of adverse event rates between treatment arms |
| Efficacy for shortening duration of SAR-CoV2 detection by PCR | weekly after treatment until 4th week | comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody detection rates | weekly after treatment until 4th week | comparison of median duration for total antibody detection in each arm |
Countries
Thailand
Contacts
Primary ContactYupin Suputtamongkol, MD
Backup ContactRujipas Sirijatuphat, MD
Outcome results
None listed