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
OBCTCD-24 Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A COVID-19 diagnosis confirmed with a SARS-CoV-2 viral infection positive polymerase chain reaction (PCR) test within 15 days from screening 2. Age =18 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 score > 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 500ng/ml 4. Willing and able to sign an informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56
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, HIV etc.). 2. Patients with PO2< 60 at room air 3. Patients with PO2/FiO2<150 4. Patients with mechanical ventilation (ECMO), or NIV, or high flow nasal cannula) or using vasopressors or patients who will probably require ICU admission, mechanical ventilation, or the use of vasopressors within 24 hours from enrolment, according to the Investigator’s judgment 5. Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding 6. Patient on long-term immunosuppression therapy, i.e., patient in active long-term inmmunosuppresion like rituximab 7. Participation in any other Interventional study in the last 30 days or within 5 half-lives of receiving an investigational agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 throughout the 28-day follow-up period. Primary Efficacy Objective: •To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19.;Secondary Objective: •To evaluate the rate of respiratory failure •To evaluate the ratio of patients with the ability to be discharged from the hospital. •To evaluate the time to improvement •To evaluate the time to recovery (COVID-19 clinical severity score of 3 or lower). •To evaluate the rate of ICU admissions •To evaluate the time from hospitalization to hospital discharge. •To evaluate the clinical outcome throughout the study period using the WHO Ordinal Scale (OS) •To assess the COVID-19-related symptoms using patient-reported outcome (PRO) measure score •To evaluate the death rate. Exploratory Objectives: •To evaluate the effect of EXO-CD24 on the respiratory rate. •To evaluate the effect of EXO-CD24 on the blood oxygen saturation (SpO2). •To evaluate the effect of EXO-CD24 on the level of inflammatory markers •Blood samples for inflammatory and other biomarkers will be stored for future analyses.;Primary end point(s): Primary Safety Endpoint: •Incidence of all adverse events by severity, related or unrelated to the study drug. Primary Efficacy Endpoint: •Rate of improvement of COVID-19 status on Day 7 (2 days post last therapy), transitioning from “Severe” to at least “Moderate” or from “Moderate” to “Moderate-Mild” using the 10-point COVID-19 clinical severity ordinal scale ;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 respiratory failure (defined as a PaO245 mmHg, or the need for mechanical ventilation, ECMO, NIV, or high-flow oxygen devices] within 28 days of the study period (Day 28). • The percentage of patients with the ability to be discharged from the hospital. • Time to improvement (transitioning from “Severe” to at least “Moderate” or from “Moderate” to “Moderate-Mild” using the 10-point COVID-19 clinical severity ordinal scale, measured from randomization (Day 1) to last study follow-up (Day 28). • Time to recovery, measured from randomization (Day 1) to recovery or last follow-up (Day 28), whichever comes first. Recovery is defined as achieving a COVID-19 clinical severity score of 3 or lower. • Percent of patients admitted to the intensive care unit (ICU) within 28 days of the study period. • Hospital discharge time within 28 days of the study period, calculated from the day of randomization (Day 1) to discharge or the last follow-up (Day 28), whichever comes first. • Percentage of patients reporting each severity rating on the OS within 28 days of the study period (Day 1 to Day 28). • Change from baseline in the COVID-19 clinical severity OS [before-treatment assessment (Screening/Day 1)] up to Day 28. • Change from baseline in the PRO score of the COVID-19-Related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment questionnaire (2). • Death rate at end of study (Day 28). Exploratory Endpoints: • Proportion of patients with respiratory rate 94%, on room air, at every visit until Day 28, inclusive. • Change [decrease/no change (±2 %)/improvement] in the SpO2 saturation from baseline to Day 7 visit. • Proportion of patients with an increase from baseline of 25% in the absolute lymphocyte count, hours on Day 7. • Change in the absolute lymphocyte count from baseline to Day 7. • Proportion of patients | — |
Countries
Greece, Israel
Contacts
Public ContactCEO
OBCTCd-24 Ltd
Outcome results
None listed