COVID-19 Clinical Trial
— COVID19Official title:
Safety and Feasibility of Allogenic Mesenchymal Stromal Cells in the Treatment of COVID-19
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm. Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | December 30, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR) - The patient or legal donor agrees to participate in the study and signs the informed consent. - Patients with orange or red criteria according to the score proposed by Liao et al (2020) Exclusion Criteria: - Patient with pregnancy, are planning to become pregnant or breastfeeding - Patients with malignant blood-borne diseases such as HIV or syphilis - Not consenting for clinical trial - Patients with other than orange or red criteria according to the score proposed by Liao et al (2020) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Assessment of Overall survival at 30 days post intervention | 60 days | |
Secondary | Changes on inflammatory C-reactive protein | To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein (mg/dL) | 60 days | |
Secondary | Hospital stay | days of the patients in hospital | 60 days | |
Secondary | Oxygenation index (PaO2/FiO2) | Evaluation of functional respiratory changes: PaO2 / FiO2 ratio | 60 days | |
Secondary | Improvement in Liao's score (2020) | Improvement in Liao's score (2020) | 60 days | |
Secondary | Radiological improvement | Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19 | 60 days | |
Secondary | Time of COVID19 PCR negativity | PCR testing to check PCR negativity | 28 days |
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