Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) MedDRA version: 23.0 Level: LLT Classification code 10084270 Term: SARS-CoV-2 acute respiratory disease System Organ Class: 100000004862
Conditions
Sponsors
F4Pharma GmbH i.G.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. SARS-CoV-2 infection confirmed by PCR test 2. Hospitalised patients 3. WHO score 4-6 [28] 4. Oxygen saturation = 92% under room air 5. Breathing frequency per minute = 20 6. Patients = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 56
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 <1 - e.g., contraceptive pill, IUD or true sexual abstinence, bilateral tubal occlusion or male partner with vasectomy; also see chapter 19.2 for guidance) 5. Current participation in another interventional clinical trial with IMP or participation within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. - Proportion of patients with worsened disease state until day 28 in both treatment groups Progression/worsening of disease state will be defined as a worsened WHO score on 3 consecutive days (always compared to the BL WHO score) until day 28 (e.g., a WHO score of 5 on 3 consecutive days for a patient that had a WHO score of 4 at BL will be defined as a worsened disease);Secondary Objective: Assessment and treatment comparison of the following objectives between the FX06 and placebo group: a)Disease progression/improvement (WHO scale score) b)Lung function (partial oxygen pressure, fraction of inspired oxygen, Horowitz index) Lung function assessments will only be documented for the study if routinely done c)Oxygen saturation and breathing rate d)Systemic inflamation blood parameters e)Survival -Proportion of patients who survived until day 28 -Proportion of patients who survived until day 60 f)Capillary refill time -Proportion of patients with normal and pathological capillary refill time at baseline (as pathological: =2 s or normal: <2 s) and change to BL g)Duration of hospital stay h)Drug accountability (e.g., dose, number of administrations) i)Time to SARS-CoV-2 RT-PCR negativity in respiratory tract specimen j)Subgroup analysis: Concomitant medication and SARS-CoV-2 vaccination status k)Safety;Primary end point(s): 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. - Proportion of patients with worsened disease state until day 28 in both treatment groups;Timepoint(s) of evaluation of this end point: BL to D28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment and treatment comparison of the following objectives at all available visits and time points between the FX06 and placebo group: a) Disease progression/improvement (WHO scale score) - Proportion of patients with improved or progressed disease state - Proportion of patients with each WHO score - Average change in WHO score compared to BL - Average WHO score - Proportion of patients in each disease severity state (uninfected, mild, moderate, severe, dead) - Proportion of patients who need mechanical ventilation and number of ventilation days - Proportion of patients who need ECMO and number of days on ECMO b) Lung function (partial oxygen pressure, fraction of inspired oxygen, Horowitz index) - Absolute PaO2 (mmHg) values and change compared to BL - Absolute FiO2 (mmHg, fraction of inspired oxygen) and its change to BL - Horowitz Index (mmHg) and change to BL (Lung function assessments will only be documented for the study if routinely done) c) Oxygen saturation and breathing rate - Oxygen saturation and breathing rate and change to BL - Proportion of patients reaching > 92% oxygen saturation under room air d) Systemic inflammation (changes and normalisation in troponin, procalcitonin, CRP, leukocyte count, ferritin, D-dimers, lactate, lactate dehydrogenase, albumin) - Concentration of blood parameters and their change to BL - Proportion of patients with normalized systemic inflammation (for each inflammation parameter) e) Survival - Proportion of patients who survived until day 28 - Proportion of patients who survived until day 60 f) Capillary refill time - Proportion of patients with normal and pathological capillary refill time at baseline (as pathological: =2 s or normal: <2 s) and change to BL g) Duration of hospital stay - Length of hospital stay until day 28 or until day 60 - Proportion of patients that have been discharged from the hospital until day 28 and day 60 - Location where patients have been discharged to (if applicab | — |
Countries
Germany, Lithuania, Spain
Contacts
Public ContactClinical Research
Marta Soler
Outcome results
None listed