COVID 19 infection
Conditions
Interventions
Trade Name: Stromectol
Product Name: Stromectol
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Sponsors
Meditop Gyógyszeripari Kft
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: • [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)) ;Timepoint(s) of evaluation of this end point: Day 4, Day 7, Day 14, Day 18, Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: • [SEC 01] Time to virus clearance, defined as days from randomization (Day 1) to negative SARS-CoV-2 RT-PCR test • [SEC 02] Time to recovery in patients who have developed symptoms (absence of any symptoms mentioned under SEC02B...02E, and physiological body temperature as per SEC02A) • [SEC 02A] Time to resolution from fever (tympanic temperature = 37.5 °C, for at least 24 hours without antipyretics) • [SEC 02B] Time course of cough burden - cough remission (reduction on a scale of 0-10, compared to Day 1 baseline) • [SEC 02C] Time course of dysgeusia-ageusia (reduction on a scale of 0-10, compared to Day 1 baseline) • [SEC 02D] Time course of anosmia (reduction on a scale of 0-10, compared to Day 1 baseline) • [SEC 02E] Time course of fatigue (reduction on a scale of 0-10, compared to Day 1 baseline) • [SEC 03] Percentage of patients with hospitalization due to progression of COVID-19 • [SEC 04] Absenteeism, by self-reporting, expressed in days absent from workplace, due to COVID-19 ;Timepoint(s) of evaluation of this end point: Day 4, Day 7, Day 14, Day 18, Day 21 | — |
Countries
Hungary
Contacts
Public ContactCRO
Cortex Pharma Services
Outcome results
None listed