A study for patients with moderate or severe COVID-19 for the evaluation of the safety and efficacy of a new investigational drug using exosomes

Phase 1

• Conditions: COVID-19 disease; MedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-002184-22-GR
• Lead Sponsor: Athens Medical Society

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-05
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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 < 30/min
ii.SpO2 at room air =94% and =90%
iii.Bilateral pulmonary infiltrates >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 <800 cells/mm3
v.D-dimers =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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified