Randomized placebo controlled clinical trial evaluating the safety and efficacy of ivermectin in hospitalized patients with Covid-19 disease

Phase 1

• Conditions: Covid-19 disease; MedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-002024-21-CZ
• Lead Sponsor: Fakultní nemocnice u sv. Anny v Brne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-28
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1) Age = 18 years
2) Willingness to participate in the clinical trial expressed by signing the informed consent form
3) Patients with confirmed Covid-19 disease requiring hospitalization with at least one of the following symptoms:
a. febrile illness above 38.5 ° C;
b. shortness of breath at rest or with minimal exertion,
c. oxygen-free saturation below 93 % SpO2,
d. inability to self-service, general exhaustion and more
4) Laboratory PCR confirmed positivity SARS-CoV-2 (nasopharyngeal swab) or positive antigen test not older than 5 days.
5) Clinical trial subjects of childbearing potential must agree to the use of the following methods of contraception for the duration of clinical trial and 3 months after the end of clinical trial.
a. For women of childbearing potential using one of the following methods:
i. highly reliable contraceptive methods within 3 months after end of clinical trial: combined hormonal contraception (oral, vaginal, transdermal), progesterone-containing contraceptives with ovulation inhibition (oral, injection), intrauterine non-hormonal or hormonal body, bilateral tubal occlusion or partner vasectomy
OR
ii. sexual abstinence if it is consistent with the lifestyle of the subject.
b. For men, use one of the following methods: observance of sexual abstinence (if it is consistent with the lifestyle of the subject) or use of an adequate contraceptive method (ie condom) in the case of sexual intercourse within 3 months after the end of clinical trial.
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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

1) Pregnancy, breastfeeding, positive chorionic gonadotropin (hCG)
2) Inadequacy of classification of the subject on the basis of individual assessment of the examining physician
3) Age <18 years
4) Outpatient treatment of patients with Covid-19 disease
5) Hepatic impairment - alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST)> 3x ULN detected before IP administration
6) Known hypersensitivity to the components of the preparation
7) Eating and fluid intake disorders and conditions limiting the bioavailability of the drug
8) Participation in another clinical trial
9) BMI > 35
10) Inability to swallow drugs
11) Current use of potent CYP3A4 inhibitors: fluconazole, fluoxetine, indinavir, itraconazole, clarithromycin, nifedipine, ritomavir, verapamil, voriconazole
12) Use of ivermectin 1 month before inclusion in CT
13) Bone marrow transplantation, history of hematopoietic disorders
14) Neurological disorders such as epilepsy that are treated with GABA agonists, such as baclofen, or past suicidal ideation or attempts

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified