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

January 7, 2021 updated by: Yupin Suputtamongkol, Mahidol University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rujipas Sirijatuphat, MD
  • Phone Number: +66840665961

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
        • Contact:
        • Contact:
        • 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
    • N/A = Not Applicable
      • Bangkok, N/A = Not Applicable, Thailand, 10700
    • Nakhonpathom
      • Amphoe Maueng, Nakhonpathom, Thailand, 73000
      • Phutthamonthon District, Nakhonpathom, Thailand, 73170

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • combined darunavir/ritonavir/hydroxychloroquine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event rates
Time Frame: after first dose until day 28 of follow up
Comparison of adverse event rates between treatment arms
after first dose until day 28 of follow up
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
weekly after treatment until 4th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody detection rates
Time Frame: weekly after treatment until 4th week
comparison of median duration for total antibody detection in each arm
weekly after treatment until 4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 17, 2020

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 323/2563 (IRB3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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