Correlated Drug Terms (1)

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	Name (Synonyms)	Correlation
drug1202	Infusion IV of Mesenchymal Stem cells Wiki	1.00

Correlated MeSH Terms (3)

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	Name (Synonyms)	Correlation
D055371	Acute Lung Injury NIH	0.10
D012127	Respiratory Distress Syndrome, Newborn NIH	0.10
D012128	Respiratory Distress Syndrome, Adult NIH	0.09

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: Efficacy will be determined through differences in the proportion with either death or admission with respiratory failure requiring level 2 ventilation (NIV/CPAP/nasal high-flow) or level 3 (invasive mechanical ventilation) in the 28 days from randomisation.

Measure: Proportion progressing to respiratory failure or death (all clinically-diagnosed participants)

Time: Determined at day 28 from randomisation.

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Secondary Outcomes

Description: Efficacy will be determined through differences in the proportion with either death or admission with respiratory failure requiring level 2 ventilatory support (NIV/CPAP/nasal high-flow) or level 3 (invasive mechanical ventilation) in the 28 days from randomisation using a retrospective analysis of COVID-19 oropharyngeal swabs for those who had one taken at time of randomisation.

Measure: Proportion progressing to respiratory failure or death (SARS-CoV-2 PCR positive)

Time: Determined at day 28 from randomisation.

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Description: Data on vital status (alive / dead, with date and presumed cause of death if appropriate)

Measure: All cause mortality

Time: Ascertain data at 28 days after randomisation.

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Description: Progression to pneumonia as diagnosed by chest x-ray (or CT thorax), with compatible clinical findings, if no pneumonia is present at time of enrolment. To be diagnosed by a medically qualified doctor and data obtained from review of case-notes and relevant radiology.

Measure: Proportion progressing to pneumonia.

Time: Ascertain this information at time of pneumonia diagnosis, or at 28 days after randomisation (whichever is sooner)

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Description: Evolution of pneumonia, as diagnosed by chest x-ray or CT thorax, if pneumonia is present at time of enrolment. To be diagnosed by a medically qualified doctor and data obtained from review of case-notes and relevant radiology. Severe pneumonia is defined as BTS CURB-65 score of 3-5.

Measure: Proportion progressing to severe pneumonia

Time: Ascertain this information at time of pneumonia diagnosis, or at 28 days after randomisation (whichever is sooner)

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Description: The 9-point ordinal scoring system is described in the protocol reflects the severity of respiratory illness. The maximum severity score during the entire study period will be compared.

Measure: Peak severity of illness

Time: Ascertain from day 14 and day 28 telephone call and from retrospective ePR/medical notes data at 28 days after randomisation.

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Description: Serious adverse events and concomitant medications. Record at enrolment, emergently during study period and proactively elicit at day 14 and at day 28.

Measure: Safety and tolerability

Time: Emergent data collection days 0-28 and elicit proactively at day 14 and day 28 post randomisation.

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Other Outcomes

Description: The following samples may be taken. Blood for serum, Tempus tube (whole blood RNA), EDTA tubes (PBMC), nasal brush to be placed immediately into RNA lysis buffer (for subsequent PCR and transcriptomic analysis). Includes assessment of mycoplasma prevalence for subgroup analysis.

Measure: Mechanistic analysis of blood and nasal biomarkers if available

Time: Samples to be collected prospectively at baseline and again if patient admitted, to be taken as soon as possible and within 72 hours of admission if possible.

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