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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435587
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : June 23, 2020
Sponsor:
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. 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 approximately weekly until discharge.
  • Weekly complete blood counts, blood chemistries, electrocardiography will be performed for adverse event monitoring.
  • 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2021


Arm Intervention/treatment
Experimental: ivermectin
oral ivermectin 600 mcg/kg/day once daily 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
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
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 co-morbidity such as chronic lung disease, chronic kidney disease, cardiovascular diseases, arrythmia, diabetes mellitus with HbA1C > 8%,BMI >35 kg/M2, 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


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

Locations
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Thailand
Siriraj Hospital
Bangkok Noi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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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: June 23, 2020
Last Verified: June 2020
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:
ivermectin
hydroxychloroquine/darunavir/ritonavir
SAR-CoV2
asymptomatic infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Asymptomatic Infections
Asymptomatic Diseases
Disease Attributes
Pathologic Processes
Ritonavir
Darunavir
Hydroxychloroquine
Ivermectin
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antirheumatic Agents