Clinical trial NCT04435587: Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asymptomatic Infections
SARS-CoV2 Infection
Keywords: ivermectin
hydroxychloroquine/darunavir/ritonavir
SAR-CoV2
asymptomatic infection
zinc sulfate
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adverse event rates
timeFrame: after first dose until day 28 of follow up
measure: Efficacy for shortening duration of SAR-CoV2 detection by PCR
timeFrame: weekly after treatment until 4th week
Secondary outcomes:
measure: Antibody detection rates
timeFrame: weekly after treatment until 4th week
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
city: Bangkok
country: Thailand
facility: Siriaj Hospital
state: N/A = Not Applicable
city: Amphoe Maueng
country: Thailand
facility: Sireethorn Nimitvilai
state: Nakhonpathom
city: Phutthamonthon District
country: Thailand
facility: Golden Jubilee Medical Center
state: Nakhonpathom
Study officials:
affiliation: Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Yupin Suputtamongkol, MD
role: PRINCIPAL_INVESTIGATOR
References: