Status:
COMPLETED
Ivermectin Reproposing for Mild Stage COVID-19 Outpatients
Lead Sponsor:
Ministry of Public Health, Argentina
Conditions:
Covid19
SARS (Severe Acute Respiratory Syndrome)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
Technical Design: Cluster Randomised Trials in outpatients care, n = 254. The subjects were divided into experimental (EG: n = 110) and control groups (CG: n = 144). The criteria for this choice were...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2021
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04784481
Start Date
September 20 2020
End Date
January 18 2021
Last Update
April 26 2021
Active Locations (1)
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1
SI.PRO.SA, Ministerio de Salud Pública
San Miguel de Tucumán, Argentina, 4000