Asymptomatic InfectionsPhase 4IDRA-COVID19NCT04435587
Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection
A Phase 4 study testing Ivermectin Pill and Combined ART/hydroxychloroquine in people with Asymptomatic Infections and SARS-CoV2 Infection, run by Mahidol University at 4 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asymptomatic Infections, SARS-CoV2 Infection
- What is being tested?
- Ivermectin Pill and Combined ART/hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesThailand
- Study dates
- 13 Jul 2020to Nov 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Rujipas Sirijatuphat, MD contact
Thailand4 sites, 4 recruiting
- Recruiting
Sireethorn Nimitvilai
Amphoe Maueng, Nakhonpathom, 73000
Sireethorn Nimitvilai, MD, sireethorn200@gmail.com
- Recruiting
Siriaj Hospital
Bangkok, N/A = Not Applicable, 10700
Yupin Suputtamongkol, MD, 66817545573, ysuputtamongkol@gmail.com
Rujipas Sirijatuphat, rujipas.sir@mahidol.ac.th
- Recruiting
Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Yupin Suputtamongkol, MD, +66817545573, ysuputtamongkol@gmail.com
Rujipas Sirijatuphat, MD, +66840665961, rujipas21@gmail.com
- Recruiting
Golden Jubilee Medical Center
Phutthamonthon District, Nakhonpathom, 73170
Dechathorn Rassamekulthana, MD, dechathorn.ras@mahidol.ac.th
Nuttawut Rongkiettechakorn, MD, nuttawut.sir@mahidol.edu
About this study
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
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.
Read the 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.
- Conditions
- Asymptomatic Infections, SARS-CoV2 Infection
- Being tested
- Ivermectin Pill, Combined ART/hydroxychloroquine
- Keywords
- ivermectin, hydroxychloroquine/darunavir/ritonavir, SAR-CoV2, asymptomatic infection, zinc sulfate
- Medical subject headings
- Asymptomatic Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin PillDrug
Also called Vermectin
3 days of once daily oral ivermectin 600mcg/kg/d
Combined ART/hydroxychloroquineDrug
Also called combined darunavir/ritonavir/hydroxychloroquine
- Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid
- Darunavir/ritonavir (400/100mg) q 12 hours for 5 days
| Study group | Role | What they receive |
|---|---|---|
| ivermectin | Experimental | 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 Receives: Drug: Ivermectin Pill |
| ART/hydroxychloroquine | Active comparator | 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 Receives: Drug: Combined ART/hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event rates
Comparison of adverse event rates between treatment arms
Measured: after first dose until day 28 of follow up
Efficacy for shortening duration of SAR-CoV2 detection by PCR
comparison of median duration for detectable SAR-CoV2 by PCR from NP swab in each arm
Measured: weekly after treatment until 4th week
Secondary outcomes (1)
Antibody detection rates
comparison of median duration for total antibody detection in each arm
Measured: weekly after treatment until 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start13 Jul 2020
- Primary completionJun 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic InfectionsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yupin Suputtamongkol, Mahidol University
- Investigators
- Yupin Suputtamongkol, MD, Principal investigator, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435587
- Sponsor's protocol ID
- 323/2563 (IRB3)
- Acronym
- IDRA-COVID19
- Status last verified
- Jan 2021
- First submitted
- 15 Jun 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04435587
- Acronym / sponsor ID
- IDRA-COVID19 / 323/2563 (IRB3)
- Conditions
- Asymptomatic Infections, SARS-CoV2 Infection
- Keywords
- ivermectin, hydroxychloroquine/darunavir/ritonavir, SAR-CoV2, asymptomatic infection, zinc sulfate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ivermectin | Experimental | Drug: Ivermectin PillCombination 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 |
| ART/hydroxychloroquine | Active comparator | Drug: Combined ART/hydroxychloroquineCombination 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivermectin PillAlso: Vermectin3 days of once daily oral ivermectin 600mcg/kg/d | Drug | ivermectin |
| Combined ART/hydroxychloroquineAlso: combined darunavir/ritonavir/hydroxychloroquine1. Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid 2. Darunavir/ritonavir (400/100mg) q 12 hours for 5 days | Drug | ART/hydroxychloroquine |
Primary outcome
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
1 secondary outcome
Antibody detection rates
Time frame: weekly after treatment until 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rujipas Sirijatuphat, MD contact
Yupin Suputtamongkol, MD principal investigator
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivermectin Pill and Combined ART/hydroxychloroquine in people with Asymptomatic Infections and SARS-CoV2 Infection, run by Mahidol University at 4 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yupin Suputtamongkol, MD (+66817545573, ysuputtamongkol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event rates (time frame: after first dose until day 28 of follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.