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Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection (IDRA-COVID19)

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ClinicalTrials.gov Identifier: NCT04435587
Recruitment Status : Unknown
Verified January 2021 by Yupin Suputtamongkol, Mahidol University.
Recruitment status was:  Recruiting
First Posted : June 17, 2020
Last Update Posted : January 11, 2021
Information provided by (Responsible Party):
Yupin Suputtamongkol, Mahidol University

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.

Condition or disease Intervention/treatment Phase
Asymptomatic Infections SARS-CoV2 Infection Drug: Ivermectin Pill Drug: Combined ART/hydroxychloroquine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: PCR for SAR-CoV2 detection will be performed by technician without knowledge of treatment arm
Primary Purpose: Treatment
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
Actual Study Start Date : July 13, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Experimental: ivermectin

Combination of

  1. oral ivermectin 600 mcg/kg/day once daily for 3 days
  2. Zinc sulfate (100mg/tab) 2 tab every 12 hours for 3 days
Drug: Ivermectin Pill
3 days of once daily oral ivermectin 600mcg/kg/d
Other Name: Vermectin

Active Comparator: ART/hydroxychloroquine

Combination of

  1. Day1 hydroxychloroquine 400mg bid, then 200mg bid on Day 2-5
  2. Darunavir/ritonavir (400/100mg) every 12 hours for 5 days
  3. Zinc sulfate (100/tab) 2 tab every 12 hours for 5 days
Drug: Combined ART/hydroxychloroquine
  1. Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid
  2. Darunavir/ritonavir (400/100mg) q 12 hours for 5 days
Other Name: combined darunavir/ritonavir/hydroxychloroquine

Primary Outcome Measures :
  1. Adverse event rates [ Time Frame: after first dose until day 28 of follow up ]
    Comparison of adverse event rates between treatment arms

  2. Efficacy for shortening duration of SAR-CoV2 detection by PCR [ Time Frame: weekly after treatment until 4th week ]
    comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm

Secondary Outcome Measures :
  1. Antibody detection rates [ Time Frame: weekly after treatment until 4th week ]
    comparison of median duration for total antibody detection in each arm

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435587

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Contact: Yupin Suputtamongkol, MD +66817545573 ysuputtamongkol@gmail.com
Contact: Rujipas Sirijatuphat, MD +66840665961

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Siriraj Hospital Recruiting
Bangkok Noi, Bangkok, Thailand, 10700
Contact: Yupin Suputtamongkol, MD    +66817545573    ysuputtamongkol@gmail.com   
Contact: Rujipas Sirijatuphat, MD    +66840665961    rujipas21@gmail.com   
Sub-Investigator: Susan Assanasen, MD         
Sub-Investigator: Nasikarn Angkasekwinai, MD         
Sub-Investigator: Methee Chayakulkeeree, MD         
Sub-Investigator: Ranistha Ratanarat, MD         
Sub-Investigator: Krittika Teerapuncharoen, MD         
Sub-Investigator: Dechathorn Rasameekultana, MD         
Sub-Investigator: Sireethorn Nimitvilai, MD         
Siriaj Hospital Recruiting
Bangkok, N/A = Not Applicable, Thailand, 10700
Contact: Yupin Suputtamongkol, MD    66817545573    ysuputtamongkol@gmail.com   
Contact: Rujipas Sirijatuphat       rujipas.sir@mahidol.ac.th   
Principal Investigator: Dechathorn Rassamekulthana, MD         
Sireethorn Nimitvilai Recruiting
Amphoe Maueng, Nakhonpathom, Thailand, 73000
Contact: Sireethorn Nimitvilai, MD       sireethorn200@gmail.com   
Golden Jubilee Medical Center Recruiting
Phutthamonthon District, Nakhonpathom, Thailand, 73170
Contact: Dechathorn Rassamekulthana, MD       dechathorn.ras@mahidol.ac.th   
Contact: Nuttawut Rongkiettechakorn, MD       nuttawut.sir@mahidol.edu   
Sponsors and Collaborators
Mahidol University
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Principal Investigator: Yupin Suputtamongkol, MD Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
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Responsible Party: Yupin Suputtamongkol, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT04435587    
Other Study ID Numbers: 323/2563 (IRB3)
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yupin Suputtamongkol, Mahidol University:
asymptomatic infection
zinc sulfate
Additional relevant MeSH terms:
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Communicable Diseases
Asymptomatic Infections
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Asymptomatic Diseases
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents