E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084272 |
E.1.2 | Term | SARS-CoV-2 infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To establish the effects of omega-3 fatty acids (Omegaven®) on inflammatory biomarkers in COVID-19 patients compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
To establish if Omegaven® increases omega-3 index and proresolving mediators.
To establish the feasibility of the study protocol.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Provision of signed informed consent prior to any study specific procedures.
2. Female and male patients ≥18 years of age.
3.COVID-19 positive or typical CT image of COVID-19 infection.
4. Clinical status requiring hospitalization. |
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E.4 | Principal exclusion criteria |
1. According to Omegaven® contraindications (serious bleeding disorders, acute life-threatening condition, including acute shock, acute myocardial infarction, acute stroke, acute emboli, and coma).
2. Known hypersensitivity to Omegaven or any of the ingredients.
3. Participation in any clinical research study evaluating an investigational medicinal product (IMP) within 3 months prior to screening.
4. Pregnancy and breastfeeding.
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in a panel of inflammatory biomarkers measured in blood samples, urine samples and released from ex vivo stimulated leukocytes after 5 days of treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 5 Days of treatment. |
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E.5.2 | Secondary end point(s) |
1. Changes in proresolving mediators after 5 days of treatment
2. Changes in omega-3 index in the erythrocyte fraction after 5 days of treatment
3. Changes in cardiac biomarkers (Troponin, NTproBNP) after 5 days of treatment
4. Changes in biomarkers of organ damage (LD, creatinine) after 5 days of treatment
5. Changes in thrombosis and coagulation parameters (platelet count, coagulation) after 5 days of treatment
6. Changes in infectious load (PCT, SARS-CoV2-RNAemia, antibodies) after 5 days of treatment
7. Effects on clinical parameters (NEWS2, oxygen need, length of hospital stay, ICU need, complications, mortality) during hospitalization
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Endpoints 1-6: After 5 Days of treatment.
Endpoint 7: During hospitalization. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |