Page 42 - Mesenchymal Stem cells, Exosomes and vitamins in the fight aginst COVID

Al-Khawaga and Abdelalim Stem Cell Research & Therapy (2020) 11:437 Page 23 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
baseline to day 28. [time frame, day 28]. baseline to day 10 and 90 [time frame, day 10, day 90].
2. Change in consolidation lesion proportion (%) of full lung
volume from baseline to day 10, 28 and 90. [time frame, day
10, 28, and 90].
3. Change in ground-glass lesion proportion (%) of full lung
volume from baseline to day 10, 28 and 90. [time frame, day
10, 28, and 90].
4. Pulmonary fibrosis-related morphological features in CT scan
at day 90.
5. Lung densitometry [time frame, days 10, 28, and 90].
6. Lung densitometry: volumes histogram of lung density
distribution (< − 750, − 750 to about − 300, − 300 to about 50,
> 50) at day 10, 28 and 90. [time frame, days 10, 28, and 90].
7. Time to clinical improvement in 28 days. [time frame, day
28].
8. Oxygenation index (PaO 2 /FiO 2 ) [time frame, days 6, 10, and
28]
9. Duration of oxygen therapy (days) [time frame, day 28 and
90].
10. Blood oxygen saturation [time frame, days 6, 10, and 28]
11. 6-min walk test [time frame, days 28 and 90].
12. Maximum vital capacity (VCmax) [time frame, baseline, days
10, 14, 21, 28, and 90].
13. Diffusing capacity (DLCO) [time frame, baseline, days 10,
14, 21, 28, and 90].
14. mMRC (Modified Medical Research Council) dyspnea scale
[time frame, day 28, Day 90].
15. Changes of absolute lymphocyte counts and subsets,
changes of cytokine/chemokine from baseline to day 6, 10, 28
and 90. [time frame, days 6, 10, 28, and 90].
16. Adverse events, serious adverse events, all-cause mortality
[time frame, day 0 through Day 90].
NCT04302519 Improvement time of ground-glass shadow in the lungs [time 1. Absorption of lung shadow absorption by CT scan-chest
frame, 14 days]. [time frame, 7, 14, 28 and 360 days]
2. Changes of blood oxygen [time frame, 3, 7 and 14 days]
NCT04273646 Pneumonia severity index [time frame, from baseline (0 w) to 1. Side effects [time frame, From Baseline (0 W) to 96 week
12 week after treatment]. after treatment].
Oxygenation index (PaO 2 /FiO 2 ) [time frame, from baseline (0 2. Survival, sequential organ failure assessment [time frame,
w) to 12 week after treatment]. day 28].
3. C-reactive protein, procalcitonin, lymphocyte count, CD3+,
CD4+ and CD8+ T cell count, CD4+/CD8+ratio [time frame,
from baseline (0 W) to 12 week after treatment].
NCT04299152 1. Percentage of activated T cells, percentage of Th17 after
therapy by flow cytometry [time frame, 4 weeks].
2. Chest imaging changes by computed tomography (CT) scan
of the chest, quantification of the SARS-CoV-2 viral load by real
time RT-PCR [time frame, 4 weeks].
NCT04269525 Oxygenation index [time frame, on the day 14 after 1. 28 day mortality rate.
enrollment]. 2. Hospital stay [time frame, up to 6 months]
3. COVID-19 antibody test on the day 7, 14, and 28.
4. Improvement of lung imaging examinations on the day 7,
14, 28
5. White blood cell count, procalcitonin, lymphocyte count, IL-
2, IL-4, IL-6, IL-10, TNF-α, γ-IFN, CRP, CD4+, CD8+, NK cells [time
frame, on the day 7, 14, 28 after enrollment]
NCT04333368 Respiratory efficacy evaluated by the increase in PaO 2 /FiO 2 1. Lung injury score, oxygenation index, in-hospital mortality,
ratio from baseline to day 7 in the experimental group mortality, ventilator-free days, number of days between
compared with the placebo group [time frame, From baseline randomization and the first day the patient meets weaning cri-
to day 7]. teria meets PaO 2 /FiO 2 > 200 (out of a prone positioning ses-
sion) [time frame, from baseline to day 28].
2. Cumulative use of sedatives, duration of use of sedatives,
duration of use of neuromuscular blocking agents (other than
used for intubation), use of neuromuscular blocking agents