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 : Recruiting
First Posted : June 17, 2020
Last Update Posted : January 11, 2021
|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
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, MDemail@example.com|
|Contact: Rujipas Sirijatuphat, MD||+66840665961|
|Bangkok Noi, Bangkok, Thailand, 10700|
|Contact: Yupin Suputtamongkol, MD +66817545573 firstname.lastname@example.org|
|Contact: Rujipas Sirijatuphat, MD +66840665961 email@example.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|
|Bangkok, N/A = Not Applicable, Thailand, 10700|
|Contact: Yupin Suputtamongkol, MD 66817545573 firstname.lastname@example.org|
|Contact: Rujipas Sirijatuphat email@example.com|
|Principal Investigator: Dechathorn Rassamekulthana, MD|
|Amphoe Maueng, Nakhonpathom, Thailand, 73000|
|Contact: Sireethorn Nimitvilai, MD firstname.lastname@example.org|
|Golden Jubilee Medical Center||Recruiting|
|Phutthamonthon District, Nakhonpathom, Thailand, 73170|
|Contact: Dechathorn Rassamekulthana, MD email@example.com|
|Contact: Nuttawut Rongkiettechakorn, MD firstname.lastname@example.org|
|Principal Investigator:||Yupin Suputtamongkol, MD||Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University|