X06 to rescue acute respiratory distress syndrome during Covid-19 pneumonia : FX-COVID

Phase 1

• Conditions: Patients admitted in participating ICUs who received mechanical ventilation for SARS-CoV-2 induced acute respiratory distress syndrome (ARDS); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002056-20-FR
• Lead Sponsor: Assistance Publique -Hôpitaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-15
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Age = 18 years
2.SARS-CoV-2 induced pneumonia confirmed by a positive PCR test in nasopharyngeal swab or respiratory tract secretions
3. Acute respiratory distress syndrome (ARDS) according to Berlin criteria (bilateral pulmonary infiltrates on frontal chest x-ray, PaO2/FiO2 ratio =300 mmHg, objective assessment excluding hydrostatic pulmonary oedema)
4.Need for endotracheal intubation and mechanical ventilation
5.Informed consent by patient or legal representative According to the specifications of emergency consent, randomization without the close relative or surrogate consent could be performed.
6.Affiliated to a social security system
7.Highly effective method of contraception (oral contraception associated with inhibition of ovulation, intrauterine device or hormone releasing system, bilateral tubal occlusion, vasectomized partner or sexual abstinence for more than three months before inclusion) and negative highly sensitive pregnancy test, for women of childbearing potential
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 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

1.Mechanically ventilation for more than 4 days
2.Patient receiving drugs interfering with inflammation: non-steroidal anti-inflammatory drugs, immunoglobulins.
3.Patients receiving chemotherapy, radiotherapy or immunotherapy for malignancy
4.Participation in another interventional clinical trial
5.Women pregnant or lactating
6.Patient moribund on the day of randomization, defined by a SAPS-II score>90
7.Contra-indication for vascular access implantation for transpulmonary thermodilution monitoring
8.Severe or terminal renal insufficiency (creatinine clearance <30 ml/min)
9.Severe hepatic insufficiency (hepatic SOFA score>2)
10.Severe cardiac insufficiency, with left ventricular ejection fraction<30%
11.Any history of severe allergic drug reaction (anaphylactic shock or allergic angioedema)
12.Persons deprived of their liberty by a judicial or administrative decision (guardianship or tutelage measure)

Study & Design

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