Status:
TERMINATED
A Study to Compare the Efficacy and Safety of Different Doses of Ivermectin for COVID-19
Lead Sponsor:
Universidade Federal de Sao Carlos
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of thes...
Eligibility Criteria
Inclusion
- Diagnosis of infection by SARS-CoV-2:
- symptoms of acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath) and biomolecular diagnosis of SARS-CoV-2 infection; OR
- any acute respiratory disease AND biomolecular diagnosis of SARS-CoV-2 infection; OR
- severe acute respiratory infection (fever and at least one sign / symptom of respiratory disease eg cough, fever, shortness of breath) AND in need of hospitalization AND biomolecular diagnosis of SARS-CoV-2 infection;
- Eastern Cooperative Oncology Group Performance Status score 0 to 1;
- National Early Warning Score 0 to 4;
- Ability to understand and consent to participate in this clinical trial, manifested by signing the Informed Consent Form (ICF).
Exclusion
- Inability to ingest / absorb the study drug orally through spontaneous ingestion or use of gastro / enteral tubes;
- Any finding of clinical observation (history / physical evaluation) that is interpreted by the investigating physician as a risk to participate in the trial;
- Any laboratory test findings that the investigating physician considers as a risk to the research participant as to his / her participation in the clinical study;
- Any ECG examination finding that the investigating physician considers as a risk to the research participant as to his / her participation in the trial;
- Known hypersensitivity to the components of the drugs used during the study;
- Women in pregnancy or breastfeeding;
- Body weight less than 15kg;
- Estimated glomerular filtration rate (CKD-Epidemiology Collaboration, CKD-EPI) \<30 mL / min;
- Aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT)\> 5 times the upper limit of normality;
- Refusal to participate;
- Refusal to sign the informed consent form.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04431466
Start Date
July 1 2020
End Date
December 1 2020
Last Update
October 12 2021
Active Locations (2)
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1
Hospital Univeristário da Universidade Federal de São Carlos (HU-UFSCar)
São Carlos, São Paulo, Brazil, 13565-905
2
Hospital Universitário da Universidade Federal de São Carlos (HU-UFSCar)
São Carlos, São Paulo, Brazil, 13566-448