Official Title
Comparative Efficacy of Ivermectin Versus Combination of Hydroxychloroquine Plus Darunavir/ Ritonavir for Shortening Duration of SARS-CoV2 Detection From Respiratory Secretion Among Asymptomatic or Afebrile COVID-19 Infection
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.

Unknown status
Asymptomatic Infections
SARS-CoV2 Infection

Drug: Ivermectin Pill

3 days of once daily oral ivermectin 600mcg/kg/d
Other Name: Vermectin

Drug: Combined ART/hydroxychloroquine

Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid
Darunavir/ritonavir (400/100mg) q 12 hours for 5 days
Other Name: combined darunavir/ritonavir/hydroxychloroquine

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Thailand
Locations

Siriraj Hospital
Bangkok Noi, Bangkok, Thailand

Siriaj Hospital
Bangkok, N/A = Not Applicable, Thailand

Sireethorn Nimitvilai
Amphoe Maueng, Nakhonpathom, Thailand

Golden Jubilee Medical Center
Phutthamonthon District, Nakhonpathom, Thailand

Contacts

Yupin Suputtamongkol, MD
+66817545573
ysuputtamongkol@gmail.com

Rujipas Sirijatuphat, MD
+66840665961

Yupin Suputtamongkol, MD, Principal Investigator
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Mahidol University
NCT Number
Keywords
Ivermectin
hydroxychloroquine/darunavir/ritonavir
SAR-CoV2
asymptomatic infection
zinc sulfate
MeSH Terms
Infections
Communicable Diseases
COVID-19
Asymptomatic Infections
Ritonavir
Darunavir
Hydroxychloroquine
Ivermectin