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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ivermectin | Experimental | Combination of
|
|
| ART/hydroxychloroquine | Active Comparator | Combination of
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin Pill | Drug | 3 days of once daily oral ivermectin 600mcg/kg/d |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rates | Comparison of adverse event rates between treatment arms | after first dose until day 28 of follow up |
| Efficacy for shortening duration of SAR-CoV2 detection by PCR | comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm | weekly after treatment until 4th week |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody detection rates | comparison of median duration for total antibody detection in each arm | weekly after treatment until 4th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yupin Suputtamongkol, MD | Contact | +66817545573 | ysuputtamongkol@gmail.com | |
| Rujipas Sirijatuphat, MD | Contact | +66840665961 |
| Name | Affiliation | Role |
|---|---|---|
| Yupin Suputtamongkol, MD | Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Recruiting | Bangkok Noi | Bangkok | 10700 | Thailand |
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PCR for SAR-CoV2 detection will be performed by technician without knowledge of treatment arm
| Combined ART/hydroxychloroquine | Drug |
|
|
|
| Siriaj Hospital | Recruiting | Bangkok | N/A = Not Applicable | 10700 | Thailand |
|
| Sireethorn Nimitvilai | Recruiting | Amphoe Maueng | Nakhonpathom | 73000 | Thailand |
|
| Golden Jubilee Medical Center | Recruiting | Phutthamonthon District | Nakhonpathom | 73170 | Thailand |
|
| ID | Term |
|---|---|
| D058345 | Asymptomatic Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D007239 | Infections |
| D058070 | Asymptomatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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