Ivermectin Reproposing for Mild Stage COVID-19 Outpatients

• Status: Completed
• Trial end date: 2021-01-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Public Health, Argentina
• Treatments: Ivermectin

Criteria

Inclusion Criteria:

• Outpatients infected by SARSCoV-2 confirmed either by RT-PCR test, Neo Kit or rapid test authorized by ANMAT or by close contact or epidemiological link;

• Women of childbearing age with a negative pregnancy test;

• Mild disease-patients with two or more of the following symptoms: fever less than 38·5°C and higher than 37.5°C according to Ministry of Health, Argentina(16), isolated diarrheal episodes, hyposmia or hypogeusia, mild desaturation (between 96 and 93%), dyspnea, polyarthralgia, persistent headache, abdominal pain, erythema of the kidney, nonspecific rash.

Exclusion Criteria:

• Hypersensitivity or allergy to Ivermectin;

• Pregnant or lactating;

• Children or adolescents under 18 years of age;

• Patients with Neurological Pathology, Renal Insufficiency, Hepatic Insufficiency;

• Weight less than 40kg;

• Patients with concomitant use of drugs that act on GABA, barbiturate and benzodiazepine receptors;

• Patients who have not completed / signed the informed consent.