Page 44 - Mesenchymal Stem cells, Exosomes and vitamins in the fight aginst COVID

Al-Khawaga and Abdelalim Stem Cell Research & Therapy (2020) 11:437 Page 25 of 33

Table 4 The investigated outcomes of the ongoing clinical trials using MSCs and MSC-derived exosomes to treat COVID-19 patients
(Continued)
Clinical trial Primary Outcome Measure Secondary Outcome Measure
identifier
week 4].
NCT04392778 Clinical improvement [time frame, 3 months]. Lung damage improvement, SARS-Cov-2 viral infection labora-
tory test, blood test [time frame, 3 months].
NCT04371601 Changes of oxygenation index (PaO 2 /FiO 2 ), blood gas test Detection of TNF-α levels, IL-10 levels, immune cells that secret
[time frame, 12 months]. cytokines, including CXCR3+, CD4+, CD8+, NK+ cells, and
regulatory T cells (CD4+ CD25+ FOXP3+ Treg cells). Changes
of oxygenation index (PaO 2 /FiO 2 ), blood gas test, changes of
c-reactive protein and calcitonin [time frame, 1, 3, 6, 12
months].
NCT04355728 Incidence of pre-specified infusion associated adverse events 1. Survival rate after 90 days post first infusion [time frame, 90
[time frame, day 5]. days].
Incidence of severe adverse events [time frame, 90 days]. 2. Small Identification Test (SIT) scores [time frame, At baseline,
day 18 and day 28].
3. CBC, CMP, D-dimer, and alloantibodies levels [time frame,
Baseline, 28 days].
NCT04362189 Interleukin-6, C reactive protein, oxygenation, TNF alpha, IL-10 1. CBC, CMP, D-dimer, INR, CD4+/CD8+ ratio, NK cells [time
[time frame, day 0, 7. 10]. frame, screening, day 0, 7, 10].
Return to room air (RTRA) [time frame, day 0, 3, 7, 10, 28]. 2. CT scan [time frame, days 0 and 28].
3. PCR test for SARS-CoV-2 [time frame, day 0, 3, 7, 10].
NCT04390152 Intergroup mortality difference with treatment [time frame, 28 1. Number of patients with treatment-related adverse events
days]. [time frame, 6 months].
2. Difference in days of mechanical ventilation between
groups [time frame, From ICU admission to 180 days].
3. Median reduction of days of hospitalization, reduction of
days of oxygen needs [time frame, from hospital admission to
180 days].
4. Difference in APACHE II score between groups [time frame,
baseline and 7 days]
5. CBC, CMP, LDH, IL-6, IL-10, TNF-alpha [time frame, baseline
to 7 days].
NCT04377334 Lung injury score [time frame, day 10]. D-dimer, immune cell phenotype, pro-resolving lipid media-
tors, cytokines, chemokines day 0, 1, 2, 3, 10 and 15, survival
(day 10 and 28), extubation (day 28), lymphocyte subpopula-
tions, SARS-CoV-2-specific antibody titers and complement
molecules (C5-C9) (day 0, 5 and 10).
NCT04331613 Adverse reaction (AE) and severe adverse reaction (SAE), CBC, CMP, IL-1beta, IL-2, IL-6, IL-8, lactate, procalcitonin, CRP,
changes of lung imaging examinations [time frame, Within 28 CK, and rate of all-cause mortality within 28 days.
days after treatment].
NCT04390139 All-cause mortality at day 28 [time frame, day 28]. Safety, need for treatment with rescue medication, duration of
mechanical ventilation, ventilator-free days, evolution of PaO 2 /
FiO 2 ratio, SOFA index, APACHE II score, duration of
hospitalization, evolution of markers of immune response
(leucocyte count, neutrophils), feasibility of MSC administration,
LDH, ferritin.
NCT04400032 Treatment-related adverse events [time frame, at time of Number of participants alive and number of participants with
infusion-12 months]. ventilator-free by day 28.
NCT04398303 Mortality at day 30 [time frame, 30 days post-treatment]. Improvement in ventilator settings [time frame, 28–30 days
post-treatment].
NCT04365101 Phase 1: frequency and severity of adverse events (AE), rate of Mortality rate and impact on sequential organ failure
clearance of SARS-CoV-2, clinical improvement [time frame, up assessment (SOFA) score pulmonary clearance [time frame, up
to 12 months]. to 28 days].
Phase 2: Time to clearance of SARS-CoV-2, clinical improve-
ment by NEWS2 Score [time frame, up to 28 days].
NCT04393415 Clinical improvement [time frame, 2 weeks]. N.A.
NCT04397796 Adverse event and mortality rates [time frame, 30 days] 1. Change in NEWS from baseline (NEWS of ≤ 2 [time frame,
Ventilator-free days [time frame, 60 days]. 30 days]).
2. SOFA score on days 8, 15, 22, and 29.
NCT03042143 Oxygenation index (OI) [time frame, day 7]. 1. SOFA score [time frame, days 4, 7 and 14].