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

NCT04435587 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-01-11

No results posted yet for this study

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.

Conditions

  • Asymptomatic Infections
  • SARS-CoV2 Infection

Interventions

DRUG

Ivermectin Pill

3 days of once daily oral ivermectin 600mcg/kg/d

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

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Yupin Suputtamongkol, MD · Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2021-06-30
Completion
2021-11-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04435587 on ClinicalTrials.gov