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

SARS-CoV2 Infection Clinical Trial

— IDRA-COVID19  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04435587
• Other study ID #: 323/2563 (IRB3)
• Status: Recruiting
• Phase: Phase 4
• Start date: July 13, 2020
• Est. completion date: November 2021

Study information

• Verified date: January 2021
• Source: Mahidol University
• Contact: Yupin Suputtamongkol, MD
• Phone: +66817545573
• Email: ysuputtamongkol[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Infections
• Communicable Diseases
• Infection
• SARS-CoV2 Infection

Intervention

Drug:
• Ivermectin Pill
3 days of once daily oral ivermectin 600mcg/kg/d
• Combined ART/hydroxychloroquine
Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid Darunavir/ritonavir (400/100mg) q 12 hours for 5 days

Locations

Country	Name	City	State
Thailand	Sireethorn Nimitvilai	Amphoe Maueng	Nakhonpathom
Thailand	Siriaj Hospital	Bangkok	N/A = Not Applicable
Thailand	Siriraj Hospital	Bangkok Noi	Bangkok
Thailand	Golden Jubilee Medical Center	Phutthamonthon District	Nakhonpathom

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event rates	Comparison of adverse event rates between treatment arms	after first dose until day 28 of follow up
Primary	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	weekly after treatment until 4th week
Secondary	Antibody detection rates	comparison of median duration for total antibody detection in each arm	weekly after treatment until 4th week