COVID-19 Clinical Trial
— COVIDMESOfficial title:
A Prospective, Double-blind, Randomized, Parallel, Placebo-controlled Pilot Clinical Trial for the Evaluation of the Efficacy and Safety of Two Doses of WJ-MSC in Patients With Acute Respiratory Distress Syndrome Secondary to Infection by COVID-19
Verified date | January 2023 |
Source | Banc de Sang i Teixits |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.
Status | Completed |
Enrollment | 26 |
Est. completion date | December 20, 2022 |
Est. primary completion date | December 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Positive PCR fpr SARS-CoV-2 2. Intensive Care Unit admission for less than 3 days 3. Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg < PaO2/FiO2 = 200 mmHg) 4. Male or female, aged 18 to 70 years old 5. Signed informed consent by the patient or by a legal representative (in this case, can be obtained by phone, although it must be confirmed in writing later, accepted by email) Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic de Barcelona | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Vall d'Hebron | Barcelona | |
Spain | Hospital de Bellvitge | Hospitalet de Llobregat | Barcelona |
Spain | Mútua de Terrassa | Terrassa | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Banc de Sang i Teixits |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Analysis of subpopulations of lymphocytes and immunoglobulins | Blood sample analysis | Day 28 | |
Other | Evaluation of the in vitro response of the receptor lymphocytes | In vitro response will be assessed using commercial viral antigens (Miltenyi Biotech) | Day 28 | |
Other | Study of reactivity against SARS-CoV-2 peptides | Reactivity will be assessed using ELISPOT | Day 28 | |
Other | Immunophenotypic study of memory cells in response to SARS-CoV-2 peptides | Blood sample analysis | Day 28 | |
Other | Genetic variability of patient's genotype in response to treatment | Blood sample analysis for the patient's genomic sequencing | Day 28 | |
Other | Genetic variability of the SARS-CoV-2 genotype in response to treatment | Genomic sequencing of the SARS-CoV-2 in a nasopharyngeal sample | Day 28 | |
Primary | All-cause mortality at day 28 | Number of patients who died, by treatment group | Day 28 | |
Secondary | Safety of WJ-MSC | Number of patients with treatment-emergent adverse events, by treatment group | Day 28 | |
Secondary | Need for treatment with rescue medication | Number of patients who, after the start of treatment, required rescue medication, by treatment group | Day 28 | |
Secondary | Need and duration of mechanical ventilation | Number of days that the patient requires invasive mechanical ventilation from the start of treatment to day +28, by treatment group | Day 28 | |
Secondary | Ventilator free days | Days after treatment in which the patient remains alive and free of invasive mechanical ventilation, per treatment group. | Day 28 | |
Secondary | Evolution of PaO2 / FiO2 ratio | Variation of the oxygenation index (PaO2 / FiO2) with respect to the baseline value, by treatment group. | Day 28 | |
Secondary | Evolution of the SOFA index | Variation of the score of the Sequential Organ Failure Assessment (SOFA) Index with respect to the baseline value, by treatment group. | Day 28 | |
Secondary | Evolution of the APACHE II score | Variation of Acute Physiology and Chronic Health disease Classification System II (APACHE II) score, by treatment group. | Day 28 | |
Secondary | Duration of hospitalization | Days of stay in the ICU from the day of admission until discharge to day 28, or date of death if earlier, by treatment group. | Day 28 | |
Secondary | Evolution of markers of immune response (leucocyte count, neutrophils) | Variation in the count and percentage of leukocytes and neutrophils, by treatment group. | Day 28 | |
Secondary | Feasibility of WJ-MSC administration | Feasibility will be evaluated by the time elapsed from the request of the treatment by the hospital center until the delivery date | Day 28 | |
Secondary | Feasibility of WJ-MSC administration | Feasibility will be evaluated by the number of patients treated within 2 days of the request for treatment. | Day 28 | |
Secondary | Evolution of disease biomarker: polymerase chain reaction (RT-PCR) | Variation in the values of the biomarker, by treatment group. | Day 28 | |
Secondary | Evolution of disease biomarker: lactate dehydrogenase (LDH) | Variation in the values of the biomarker, by treatment group. | Day 28 | |
Secondary | Evolution of disease biomarker: D-dimer | Variation in the values of the biomarker, by treatment group. | Day 28 | |
Secondary | Evolution of disease biomarker: Ferritin | Variation in the values of the biomarker, by treatment group. | Day 28 |
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