COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001505-22/ES

Banc de Sang i Teixits

rucoll@bst.cat

2020-04-27

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Participation in the prospective observational epidemiological study CIBERESUCICOVID (PCR for SARS-CoV-2 positive, ICU admission) 2. Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg < PaO2/FiO2 ≤ 200 mmHg) 3. Male or female, aged 18 to 70 years old 4. Signed informed consent by the patient or by a legal representative 1. Participación en el estudio epidemiológico observacional prospectivo CIBERESUCICOVID (PCR para SARS-CoV-2 positivo, ingreso en UCI) 2. Distrés respiratorio agudo moderado (definición de Berlín con 100 mmHg < PaO2/FiO2 ≤ 200 mmHg) 3. Paciente de 18 a 70 años, ambos sexos 4. Firma del consentimiento informado por parte del paciente o por un representante válido

1. Expected survival less than 3 days 2. Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed 3. Neoplastic disease either active or without complete remission 4. Immunosuppressed patients (except treatment with corticosteroids for respiratory distress) 5. Pregnant or lactating women 6. Participation in another clinical trial with an experimental drug in the last 30 days 7. Other pathologies that, in medical judgment, contraindicate participation in the study 1. Supervivencia esperada menor de 3 días 2. Tratamiento con fármacos inmunosupresores (tocilizumab, sarilumab) estando permitidos los corticosteroides 3. Enfermedad neoplásica activa o sin remisión completa 4. Pacientes inmunodeprimidos (excepto tratamiento con corticoides para el distrés respiratorio) 5. Mujeres embarazadas o lactantes 6. Participación en otro estudio clínico con un fármaco experimental en los últimos 30 días 7. Otras patologías que, a criterio médico, contraindiquen la participación en el estudio

2

Banc de Sang i Teixits

18

70

Spain

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

30

Number of patients who died on day +28, by treatment group Número de pacientes fallecidos a día +28, por grupo de tratamiento

Declared number of arm (3.0) differs from found arms (2.0)

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 1334, "treatment_name": "Umbilical cord mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]