A randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ivermectin in asymptomatic and mild severity COVID-19 patients
- Conditions
- COVID 19 infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-000166-15-HU
- Lead Sponsor
- Meditop Gyógyszeripari Kft
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 70
• Males and females 18-75 years of age
• Ambulatory patients with confirmed SARS-CoV-2 infection by rapid antigen test OR polymerase chain reaction (PCR), regardless whether they show symptoms or are asymptomatic
• Asymptomatic or mild COVID-19 cases: NO dyspnoe and NO tachypnoe (respiratory rate <22 / min), NO need for oxygen-supplementation; NO radiological findings of pneumonia (NB. No medical imaging will be conducted within the frames of the study. If previous medical imaging report is available, its result will be however utilized.)
• Build: 20 = BMI = 28 kg/m2
• Subjects who are able to communicate with the Investigator and research staff, who understand the study, are able to comply with all study procedures, and willing to provide written informed consent prior to the screening examinations
NB. Women of childbearing potential should agree to use a highly effective method of contraception throughout the study and up to 1 month afterwards. Male subjects shall agree to effective contraception during the study and for 14 days following the last drug administration.
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
• Moderate COVID-19 cases: showing dyspnoe and / or tachypnoe, or a need for oxygen-supplementation, or radiological findings of pneumonia. {Definition of moderate COVID-19 as per Magyar Koronavírus Kézikönyv”, Igazolt COVID-19 ferto?zo¨tt felno?tt betegek riziko´stratifika´cio´ja” fejezet (Hungarian Coronavirus Manual, Section Risk stratification of confirmed adult COVID-19 patients”) } Radiological findings – established either by chest X-ray or native chest (pulmonary) CT scan - include multiplex consolidations and milk-glassy haze, often in a bilateral distribution.
• Severe COVID-19: respiratory distress - respiratory rate = 30/min; or oxygen saturation at rest = 93%; or pulmonary infiltrates occupy > 50% of the lung-fields
• Critical COVID-19: acute respiratory distress; or requiring mechanical ventilation; or radiomorphology of ARDS; or shock, including septic shock; or other organ dysfunction necessitating ICU admission
• High-risk patient for progression of COVID-19, as defined by having a calculated pneumonia PORT-score of > 90
• Concomitant or previous administration of any experimental, non-established COVID-19 therapy, either in off-label indication of a registered medicinal product or as a non-registered drug candidate in a clinical trial setting or compassionate use program (or equivalents thereof)
• NO previous COVID-19 therapies allowed, as per recommendation of the Magyar Koronavírus Kézikönyv” (Hungarian Coronavirus Manual)
• Concomitant administration of coumarin-derivatives or warfarin
• Concomitant administration of cytochrom-P450 or membrane drug transporter, especially ABCB1/P-gp and ABCG2/BCRP (breast cancer resistance protein) modifiers
• Any clinically significant abnormality identified during screening full physical examination, vital signs, laboratory tests and ECG which is deemed by the investigator to be incompatible / inappropriate for study participation
• A current or recent history of drug or substance abuse, including alcohol (> 14 units per week), within 3 months prior to screening (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or one shot [25 mL] of spirits)
• Patients who regularly consume more than 4 cups daily of beverage containing caffeine
• Current strong smoker as defined by smoking over 10 cigarettes a day, or its equivalent
• Positive pregnancy test result for women with childbearing potential at screening
• Women who are pregnant or nursing, or who are planning to get pregnant within 3 months after the last dose of study drug
• A history of allergy, intolerance or sensitivity to ivermectin or any component of the study drug formulation
• Exhibiting any pathology, contraindicated with ivermectin administration: e.g. asthma, clinically significant hepatic diseases, human immunodeficiency virus (HIV) infection, immunosuppression, onchodermatitis, Loa loa infection
• Have undergone surgery or have donated blood within 12 weeks prior to the start of the study
• A history of bleeding diathesis or other bleeding disorders
• Investigational drug administration or investigational device application within 1 month preceding study entry, or within 5 terminal half-life of the investigational drug of the previous study, whichever is the longer
• A history of malignancy within 5 years from screening visit, with the exception of resected basal cell carcinoma or squamous cell car
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary Objective: To assess the efficacy of per os ivermectin administration in asymptomatic and mild severity SARS-CoV-2 infected patients on reduction of virus load.;Secondary Objective: Secondary Efficacy Objective: Assessment of efficacy of per os ivermectin administration in mild severity SARS-CoV-2 infected patients on healing course.;Primary end point(s): Primary Endpoint:<br> • [PRIM] Percentage of SARS-CoV-2 virus copy number at Day 7 compared to baseline (i.e. 100 * (the number of virus copies at Day 7 / number of virus copies at Screening))<br><br><br>;Timepoint(s) of evaluation of this end point: Day 4, Day 7, Day 14, Day 18, Day 21<br>
- Secondary Outcome Measures
Name Time Method