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 |
Respiratory distress syndrome, which is induced by the SARS-CoV-2 Virus |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
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 |
Overall survival after 28 days after registration into this trial |
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E.2.2 | Secondary objectives of the trial |
- Overall survival after 90 days after registration into this trial - Assessment of the duration of ventilation support - Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin) - To assess time on ICU - To assess toxicity and safety of ruxolitinib treatment - To assess seroconversion under ruxolitinib (SARS-Co-19- IgG) - If possible to assess pulmonary function (time point discharge from hospital)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a patient must meet all of the following criteria: 1. Male or non-pregnant female adult ≥18 years of age at time of enrollment. 2. has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay (result of the PCR is not necessary for inclusion, but has to approved latest within 48-72 hours after registration) 3. Willingness of men and women of childbearing potential to use highly effective contraceptive methods by abstinence or by using at least two contraceptive methods from the date of consent to the end of the study 4. severe lung disease as defined by following: a. Recent intubation b. Requirement of invasive ventilation moderate to severe pulmonary oxygen exchange disturbance as defined by (PaO2/FiO2) ≤ 200 mmHg at a PEEP ≥ 5mm H2O c. Serum LDH > 283 U/l d. Ferritin above normal value e. CT-scan: pulmonary infiltration compatible with Covid-19 disease 5. Patient or patient´s representative must provide written informed consent (and assent if applicable) before any study assessment is performed.
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E.4 | Principal exclusion criteria |
An individual who meets any of the following criteria will be excluded from participation in this study: 1. Uncontrolled HIV infection 2. Active tuberculosis (result of positive tuberculosis infection is not necessary for exclusion, but has to approved later on during patient´s intervention) 3. Chronic kidney disease requiring dialysis 4. ALT/AST > 5 times the upper limit of normal. 5. Pregnancy or breast feeding. 6. Allergy to study medication 7. Simultaneous participation in another clinical trial with an experimental treatment
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
28 days after registration |
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E.5.2 | Secondary end point(s) |
- Overall survival - Assessment of the duration of ventilation support - Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin) - To assess time on ICU - To assess toxicity and safety of ruxolitinib treatment - To assess seroconversion under ruxolitinib (SARS-Co-19- IgG) - If possible to assess pulmonary function
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
90 days after registration |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 3 |
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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End of the study is defined as " Last Patient Out" and database closure |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |