SARS-CoV-2 (Severe Acute Respiratory Syndrome)
Conditions
Interventions
There will be 2 study treatments: 1 active FX06) and 1 placebo.
FX06/placebo will be administered over a 5-day period in two-bolus
administration per day. The patients will then be further observed
Sponsors
F4Pharma GmbH i.G.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. SARS-CoV-2 infection confirmed by PCR test 2. Hospitalised patients 3. WHO score 4-6 4. Oxygen saturation = 20 6. Patients >= 18 years 7. Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient 8. Willingness to comply to study procedures and study protocol 9. Patients able to understand the requirements of the study and give written informed consent
Exclusion criteria
Exclusion criteria: 1. Significant underlying known co-morbidities or conditions, defined as: o Other severe advanced or chronic lung diseases (e.g., COPD Gold >= III, severe silicosis) o End-stage chronic kidney disease (stage 5) o End-stage chronic heart failure (NYHA >= III) o Dementia o Baseline neurologic disease which would preclude rehabilitation potential o Disseminated and/or metastasised malignancy o Severe deconditioning with a life expectancy of less than 6 months according to the treating physician o Immunocompromised patients - recipient of a solid organ transplant - regular intake of anti-inflammatory therapy due to concomitant auto- immune diseases (e.g., biologics) - primary immune deficiency 2. Evidence of other significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases with a bad prognosis that are likely to interfere with the evaluation of the patient's safety and with the study outcome as judged by the treating physician 3. Women pregnant or breastfeeding 4. Males or females of reproductive potential not willing to use effective contraception for the duration of the study period (defined as PEARL index
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to demonstrate a difference in the proportion of patients with progressed/worsened disease state in patients receiving FX06 compared to patients receiving placebo until day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives and endpoints: Assessment and treatment comparison of the following objectives at all available visits and time points between the FX06 and placebo group. | — |
Countries
Netherlands
Outcome results
None listed