Pilot study to evaluate the potential of ivermectin to reduce COVID-19 transmission

Clínica Universidad de Navarra/Universidad de Navarra0 个研究点目标入组 24 人开始时间: 2020年5月8日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•-Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra with a positive SARS-CoV-2 PCR.
•-Residents of the Pamplona basin (Cuenca de Pamplona”)
•-The patient should be between the ages of 18 and 60 years of age
•-Negative pregnancy test for women of child bearing age*
•-The patient or his/her representative, have given consent to participate in the study.
•-The patient should, in the investigator's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation)
•*Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Known history of Ivermectin allergy
•-Hypersensitivity to any component of Stromectol®
•-COVID-19 Pneumonia Diagnosed by the attending physician Identified in a chest X-ray
•-Fever or cough present for more than 48 hours
•-Positive IgG against SARS-CoV-2 by rapid test
•-Age under 18 or
•-over 60 years
•-Immunosuppression
•-Chronic Obstructive Pulmonary Disease
•-Hypertension
•-Acute or chronic renal failure
•-History of coronary disease
•-History of cerebrovascular disease
•-Current neoplasm
•-Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan)
•-Current use of CYP 3A4 or P-gp inhibitor drugs (such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.)

发起方