COVID-19 disease MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Athens Medical Society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A COVID-19 diagnosis confirmed with a SARS-CoV-2 infection positive polymerase chain reaction (PCR) test within 30 days from screening. 2. Age 18-80 years. 3. Severity of disease according to the following criteria (at least one clinical parameter and one laboratory parameter are required): a. Clinical and Imaging-based evaluation i. Respiratory rate > 23/min and 25% within 24-48 hours or a severe deterioration compared to imaging at admission. b. Evidence of an exacerbated inflammatory process i. LDH =300 U/L or what is the upper limit for normal per age ii. CRP =25 mg/L iii. Ferritin =500 ng/ml iv. Lymphocytes =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Any concomitant illness that, based on the judgment of the Investigator might affect the interpretation or the results of the study (i.e., immunodeficiency). 2. Mechanically-ventilated patient or patient who will probably require ICU admission or mechanical ventilation within 24 hours from enrolment, according to the Investigator’s judgment. 3. Previous complete or partial vaccination for SARS-CoV-2. 4. Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding. 5. Participation in any other Interventional study in the last 30 days 6. Active Cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: Safety Objective: • To evaluate the safety of CovenD24 in the treatment of patients with moderate or severe COVID-19. Primary Efficacy Objectives: • To determine the minimally effective dose, as assessed by the improvement in the respiratory rate and oxygen saturation. • To determine the effect of each dose on inflammatory markers.;Secondary Objective: Secondary Efficacy Objectives: • To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower). • To evaluate respiratory failure [defined as an arterial oxygen pressure (PaO2) of 45 mmHg, or the need for mechanical ventilation, extracorporeal membrane oxygenation (ECMO), non-invasive ventilation (NIV), high-flow oxygen devices] rate. • To evaluate the death rate. • To evaluate time from hospitalization to hospital discharge. • To assess the COVID-19-related symptoms through an investigator interview. • To evaluate the effect of CovenD24 on the SpO2/FiO2 ratio. Exploratory Objective: Blood samples for interleukin 6 (IL-6) and other cytokines will be stored for future analysis.;Primary end point(s): Primary Safety Endpoints: • Incidence of treatment (dose)-related serious adverse events. • Incidence of all adverse events related or unrelated to the study treatment. Primary Efficacy Endpoints: • Proportion of patients with respiratory rate 94%, on room air for at least 24 hours, on Day 7. • Proportion of patients with a decrease by 50% in either CRP/LDH/Fibrinogen/Ferritin/D-dimers from baseline to Day 7.;Timepoint(s) of evaluation of this end point: After follow up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: • Rate of categorical and absolute score improvement of COVID-19 status on Day 7 improving from “Severe” to at least “Moderate” or from “Moderate” to “Moderate-Mild” using any of the COVID-19 clinical severity ordinal scales as described in protocol, in each dose group and the total population. • Time to recovery, measured from enrolment (Day 1) to recovery or last follow-up (Day 28). Recovery is defined as achieving the "ambulatory mild disease" classification as described in protocol. • Death rate at end of study (Day 28). • Proportion of patients with no mechanical ventilation (ECMO, NIV, high flow) on Day 7. • Proportion of patients with haemodynamic instability or requiring vasopressors on Day 7. • Change in the SpO2/FiO2 ratio on Day 7. • Time to death or respiratory failure (defined as an arterial oxygen pressure (PaO2) of 45 mmHg, or the need for mechanical ventilation, ECMO, non-invasive ventilation, or high-flow oxygen devices) within 28 days of the study period (Day 1 to Day 28). • Hospital discharge time within 28 days of the study period, calculated from the day of randomization (Day 1) to discharge or last follow-up (Day 28), whichever comes first. • Proportion of patients requiring admission to an Intensive-Care Unit (ICU) on Day 7. • Proportion of patients with respiratory rate 94% on room air, for at least 24 hours at every visit until Day 28, inclusive. • Proportion of patients with change [decrease/no change (±2 %)/improvement] in SpO2 saturation from baseline to Day 7. • Proportion of patients with an increase of 25% in the absolute lymphocyte count, sustained for =24 hours on Day 7. • Change in absolute lymphocyte count from baseline to Day 7. • Proportion of patients with a decrease of 20% in the neutrophil-to-lymphocyte ratio (NLR), sustained for =24 hours on Day 7. • Change in NLR from baseline to Day 7. • Percentage of patients within each severity rating on the ordinal scale within 28 d | — |
Countries
Greece
Contacts
Public ContactMatina Katsaouni
Athens Medical Society
Outcome results
None listed