Back to resultsIvermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection (IDRA-COVID19)
Primary Purpose
Asymptomatic Infections, SARS-CoV2 Infection
Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Ivermectin Pill
Combined ART/hydroxychloroquine
Sponsored by
About this trial
This is an interventional treatment trial for Asymptomatic Infections focused on measuring ivermectin, hydroxychloroquine/darunavir/ritonavir, SAR-CoV2, asymptomatic infection, zinc sulfate
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
Sites / Locations
- Siriraj HospitalRecruiting
- Siriaj HospitalRecruiting
- Sireethorn NimitvilaiRecruiting
- Golden Jubilee Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ivermectin
ART/hydroxychloroquine
Arm Description
Combination of oral ivermectin 600 mcg/kg/day once daily for 3 days Zinc sulfate (100mg/tab) 2 tab every 12 hours for 3 days
Combination of Day1 hydroxychloroquine 400mg bid, then 200mg bid on Day 2-5 Darunavir/ritonavir (400/100mg) every 12 hours for 5 days Zinc sulfate (100/tab) 2 tab every 12 hours for 5 days
Outcomes
Primary Outcome Measures
Adverse event rates
Comparison of adverse event rates between treatment arms
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
Secondary Outcome Measures
Antibody detection rates
comparison of median duration for total antibody detection in each arm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04435587
Brief Title
Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection
Acronym
IDRA-COVID19
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymptomatic Infections, SARS-CoV2 Infection
Keywords
ivermectin, hydroxychloroquine/darunavir/ritonavir, SAR-CoV2, asymptomatic infection, zinc sulfate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
PCR for SAR-CoV2 detection will be performed by technician without knowledge of treatment arm
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ivermectin
Arm Type
Experimental
Arm Description
Combination of
oral ivermectin 600 mcg/kg/day once daily for 3 days
Zinc sulfate (100mg/tab) 2 tab every 12 hours for 3 days
Arm Title
ART/hydroxychloroquine
Arm Type
Active Comparator
Arm Description
Combination of
Day1 hydroxychloroquine 400mg bid, then 200mg bid on Day 2-5
Darunavir/ritonavir (400/100mg) every 12 hours for 5 days
Zinc sulfate (100/tab) 2 tab every 12 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
Ivermectin Pill
Other Intervention Name(s)
Vermectin
Intervention Description
3 days of once daily oral ivermectin 600mcg/kg/d
Intervention Type
Drug
Intervention Name(s)
Combined ART/hydroxychloroquine
Other Intervention Name(s)
combined darunavir/ritonavir/hydroxychloroquine
Intervention Description
Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid
Darunavir/ritonavir (400/100mg) q 12 hours for 5 days
Primary Outcome Measure Information:
Title
Adverse event rates
Description
Comparison of adverse event rates between treatment arms
Time Frame
after first dose until day 28 of follow up
Title
Efficacy for shortening duration of SAR-CoV2 detection by PCR
Description
comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm
Time Frame
weekly after treatment until 4th week
Secondary Outcome Measure Information:
Title
Antibody detection rates
Description
comparison of median duration for total antibody detection in each arm
Time Frame
weekly after treatment until 4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yupin Suputtamongkol, MD
Phone
+66817545573
Email
ysuputtamongkol@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rujipas Sirijatuphat, MD
Phone
+66840665961
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yupin Suputtamongkol, MD
Organizational Affiliation
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yupin Suputtamongkol, MD
Phone
+66817545573
Email
ysuputtamongkol@gmail.com
First Name & Middle Initial & Last Name & Degree
Rujipas Sirijatuphat, MD
Phone
+66840665961
Email
rujipas21@gmail.com
First Name & Middle Initial & Last Name & Degree
Susan Assanasen, MD
First Name & Middle Initial & Last Name & Degree
Nasikarn Angkasekwinai, MD
First Name & Middle Initial & Last Name & Degree
Methee Chayakulkeeree, MD
First Name & Middle Initial & Last Name & Degree
Ranistha Ratanarat, MD
First Name & Middle Initial & Last Name & Degree
Krittika Teerapuncharoen, MD
First Name & Middle Initial & Last Name & Degree
Dechathorn Rasameekultana, MD
First Name & Middle Initial & Last Name & Degree
Sireethorn Nimitvilai, MD
Facility Name
Siriaj Hospital
City
Bangkok
State/Province
N/A = Not Applicable
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yupin Suputtamongkol, MD
Phone
66817545573
Email
ysuputtamongkol@gmail.com
First Name & Middle Initial & Last Name & Degree
Rujipas Sirijatuphat
Email
rujipas.sir@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Dechathorn Rassamekulthana, MD
Facility Name
Sireethorn Nimitvilai
City
Amphoe Maueng
State/Province
Nakhonpathom
ZIP/Postal Code
73000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sireethorn Nimitvilai, MD
Email
sireethorn200@gmail.com
Facility Name
Golden Jubilee Medical Center
City
Phutthamonthon District
State/Province
Nakhonpathom
ZIP/Postal Code
73170
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dechathorn Rassamekulthana, MD
Email
dechathorn.ras@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Nuttawut Rongkiettechakorn, MD
Email
nuttawut.sir@mahidol.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection
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