Effect of a food supplement on pro-inflammatory and pro-resolving mediators in patients with post-COVID-19 conditio

Not Applicable

Completed

• Conditions: Post-COVID syndrome; Infections and Infestations

• Registration Number: ISRCTN13270662
• Lead Sponsor: Insud Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-12-31
• Study Start: 2024-06-25
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following primary outcome measures are assessed using lipid mediator laboratory analyses at baseline, 4 and 12 weeks of use:<br>1. Blood samples and analytics of Polyunsaturated fatty acids: EPA, DHA, ARA, DPA. <br>2. Monohydroxylated specialized pro-resolving mediators (SPMs): 17-HDHA, 18-HEPE, 14-HDHA.<br>SPMs: Resolvins (RvE1, RvD1, RvD2, RvD3, RvD4, RvD5), Maresins (MaR1, MaR2), Protectins (PD1, PDX), Lipoxins (LXA4, LXB4. <br>3. Pro-inflammatory eicosanoid lipid mediators: Prostaglandins (PGE2, PGD2, PGF2a.), Thromboxanes (TxB2), Leukotrienes (LTB4)

Secondary Outcome Measures

Name	Time	Method
1. Fatigue measured using the Fatigue Severity Scale (FSS) test from at baseline, visit 2 (4th week of treatment, day 28) and to the end of the study (day 84 of treatment) <br>2. Dyspnea measured using the Modified Medical Research Council (mMRC) Dyspnea Scale at baseline, visit 2 (4th week of treatment, day 28) and to the end of the study (day 84 of treatment)