Ivermectin Reproposing for Mild Stage COVID-19 Outpatients

NCT04784481 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2021-04-26

No results posted yet for this study

Summary

Background:

The emergency of COVID-19, along with the current difficulties in responding to the high demand for vaccines, requests to the scientific community to find alternative treatments based on reuse of drugs as a strategy to prevent the progression of the disease in patients infected with SARS COV 2.

Objetive This study aims to evaluate the use of ivermectin in mild-stage patients to increase outpatient discharge and prevent the progression to moderate or severe stages of the disease.

Added value of this study We found that an intervention with ivermectin has impacted on the PPS in a population of outpatients care, between the 5th and 9th day. Also, the treatment increased the probability to obtain outpatient discharge, even in the presence of comorbidities.

Implications of all available evidence.

Research in Context According to the COVID-19 Treatment Guidelines by the NIH, most trials have several limitations. It needs results from adequately powered and well-designed clinical trials to provide evidence-based guidance on the role of ivermectin in the treatment of COVID- 19. However, our study shows overlaps in benefits with other authors, and taking together, these results are encouraging for further study about repurposing ivermectin for the treatment of COVID-19.

Conditions

  • Covid19
  • SARS (Severe Acute Respiratory Syndrome)

Interventions

DRUG

Ivermectin

Experimental Group received Ivermectin orally 4 tablets of 6 mg = 24 mg every 7 days for 4 weeks.

Sponsors & Collaborators

  • Ministry of Public Health, Argentina

    lead OTHER_GOV

Principal Investigators

  • Rossana E. Chahla, MD. Ph.D. · Ministery of Health, Tucumán, Argentina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-20
Primary Completion
2020-12-20
Completion
2021-01-18

Countries

  • Argentina

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 NCT04784481 on ClinicalTrials.gov