Pro-resolving inflammatory effects of a marine oil enriched in SPMs supplement and its implication in patients with a post-COVID syndrome

Insud Pharma0 个研究点目标入组 53 人开始时间: 2024年6月25日最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•1. Adult patients with post-COVID-19 conditions, both genders, between 18 and 70 years old
•1.1. Patients with clinical criteria that prove the COVID-19 infection: Diagnosis confirmed using test for COVID-19: PCR, Rapid antigen test, serological test). Symptoms must persist longer than the 12 week after the beginning of the symptoms.
•2. Patients with fatigue/asthenia, dyspnea and one of the following:
•2.1. General malaise
•2.2. Headaches
•2.3. Low mood
•2.4. Muscular pain
•3. Body mass index between 18,5 and 30 kg/m2
•4. With the ability to provide informed consent
•5. Women who participate in the study must comply one of the following conditions:
•5.1. Unable to get pregnant: women who had surgical sterilization or over two years after menopause
•5.2. Fertile women must have a negative pregnancy test prior their inclusion in the study (conducted during screening) and use a highly efficient contraceptive method, which are: hormonal contraceptives, intrauterine devices, condoms together with spermicide and gel, partner’s surgical sterilization (vasectomy) or total sexual abstinence during the study. The use of these contraceptive methods must last, at least 3 months after the last dose of the study products.

•To participate in the study, patients must comply with none of the following exclusion criteria:
•1. Pregnant or breastfeeding women
•2. Unable to use a highly efficient contraceptive method
•3. Recruited in another clinical trial
•4. Subjects involved in another clinical trial 4 weeks before their inclusion
•5. Patients with any concomitant illness or condition that could affect significantly the hematologic, renal, endocrine, pulmonary hepatic, gastrointestinal, cardiovascular, immunologic, central nervous, dermatologic or any other system, with the exceptions stated in the inclusion criteria
•6. Use of Immunosuppressant drugs or prolonged or maintained use of anti-inflammatory drugs and/or corticoids
•7. Hypersensitivity, allergy or idiosyncratic reaction to omega-3 acids. Fish or soya allergies.

发起方

Insud Pharma