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
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|Condition or disease||Intervention/treatment||Phase|
|Asymptomatic Infections SARS-CoV2 Infection||Drug: Ivermectin Pill Drug: Combined ART/hydroxychloroquine||Phase 4|
- 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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
|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|
Drug: Ivermectin Pill
3 days of once daily oral ivermectin 600mcg/kg/d
Other Name: Vermectin
Active Comparator: ART/hydroxychloroquine
Drug: Combined ART/hydroxychloroquine
Other Name: combined darunavir/ritonavir/hydroxychloroquine
- Adverse event rates [ Time Frame: after first dose until day 28 of follow up ]Comparison of adverse event rates between treatment arms
- 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
- Antibody detection rates [ Time Frame: weekly after treatment until 4th week ]comparison of median duration for total antibody detection in each arm
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|Contact: Yupin Suputtamongkol, MDfirstname.lastname@example.org|
|Contact: Rujipas Sirijatuphat, MD||+66840665961|
|Bangkok Noi, Bangkok, Thailand, 10700|
|Contact: Yupin Suputtamongkol, MD +66817545573 email@example.com|
|Contact: Rujipas Sirijatuphat, MD +66840665961 firstname.lastname@example.org|
|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|
|Bangkok, N/A = Not Applicable, Thailand, 10700|
|Contact: Yupin Suputtamongkol, MD 66817545573 email@example.com|
|Contact: Rujipas Sirijatuphat firstname.lastname@example.org|
|Principal Investigator: Dechathorn Rassamekulthana, MD|
|Amphoe Maueng, Nakhonpathom, Thailand, 73000|
|Contact: Sireethorn Nimitvilai, MD email@example.com|
|Golden Jubilee Medical Center||Recruiting|
|Phutthamonthon District, Nakhonpathom, Thailand, 73170|
|Contact: Dechathorn Rassamekulthana, MD firstname.lastname@example.org|
|Contact: Nuttawut Rongkiettechakorn, MD email@example.com|
|Principal Investigator:||Yupin Suputtamongkol, MD||Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University|
|Responsible Party:||Yupin Suputtamongkol, Professor, Mahidol University|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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