E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062357 |
E.1.2 | Term | SIRS |
E.1.2 | System Organ Class | 100000004867 |
|
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 assess the safety and preliminary efficacy of AP in reducing the inflammatory reaction in COVID-19 patients and thereby shorten time on mechanical ventilation or prevent the need for mechanical ventilation in COVID-19 patients. Secondary Objective(s): To reduce mortality rates and prevent acute kidney injury (AKI) stage 2/3 (KDIGO criteria). |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Sars-CoV-2 infection based on: highly clinical suspicion on admission and/or positive PCR test on naso¬pharynx swab or sputum and/or a CT imaging of the chest compatible with COVID-19 + type 1 or type 2 respiratory failure despite supplemental oxygen that indicates airway support/ICU admittance and meeting any of the following criteria: . - SpO2 <90% or PaO2/FiO2 < 200 mmHg - Clinical evidence of respiratory distress (RR > 25 breaths/minute)
|
|
E.4 | Principal exclusion criteria |
- Inclusion in another interventional clinical trial - Age < 18 - Age > 80 - Patients who are pregnant or lactating - Patients expected to have fatal disease within 24 hours - Patients who are already on dialysis (Renal Replacement Therapy, RRT) or a decision has been made to initiate RRT within 24 hours after planned start of study drug administration - Patients who have advanced chronic liver disease confirmed by a Child-Pugh C - Patients who are having an known history of immune system that has been impaired by disease, such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (<0.5 x 109/l) or patients who are receiving chronic high doses (equivalent to prednisone/prednisolone 0.5 mg/kg/day) steroids therapy immediately prior to recruitment exceeding 2 weeks of treatment. This means dexamethasone 6 mg once daily serving as treatment for severe COVID-19 is not an exclusion criteria. - Patients with active haematological malignancy
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
(1) Duration of mechanical ventilation and withholding of mechanical ventilation (2) ICU mortality (3) Number (%) of patients with acute kidney injury (AKI) stage 2/3 (KDIGO) (4) Concentration of pro-inflammatory cytokines
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
discharge from the hospital |
|
E.5.2 | Secondary end point(s) |
(1) ICU Mortality (2) Number (%) of patients with acute kidney injury (AKI) stage 2/3 (KDIGO criteria) (3) Number (%) of ventilated patients (4) Number (%) of patients in need for reintubation (5) Safety (according to chapter 8) (6) Values of inflammatory markers (e.g. macrophages, neutrophils, lymphocytes and their inflammatory products (TNF-α, IL-6, IL-8, IL-10))
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
discharge from the hospital |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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
|
The end of the study is defined as the last patient’s last visit. |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |