Table 2 Primary and secondary outcomes at 3 months after the diagnosis of COVID-19 pneumonia.

Full analysis set (n = 33)	Estimate (95% CI) or [interquartile range]		p-value	Treatment effect	p-value
Full analysis set (n = 33)	Cyclosporine A plus standard of care (n = 17)	Standard of care (n = 16)	p-value	Estimate (95% CI)	p-value
Primary outcome
Response without requiring IMV	76.5 (56.3–96.7)	50 (25.5–74.5)	0.114	RR: 3.250 (0.733–14.402)	0.121
Secondary outcomes
Response requiring IMV	5.9 (0.0–17.1)	0 (0–0)	1.000	RR: NC	NC
Response irrespective of need for IMV	82.4 (64.3–100.0)	50 (25.5–74.5)	0.049	RR: 2.833 (0.908–8.840)	0.057
No response due to ILD*	12.5 (0–28.2)	27.3 (5.5–49.1)	0.370	RR: 0.381 (0.052–2.784)	0.342
No response due to death	5.9 (0–17.1)	31.3 (8.4–53.8)	0.085	RR: 0.138 (0.014–1.344)	0.342
Need for IMV	11.8 (0–27.1)	37.5 (13.8–61.2)	0.118	RR: 0.138 (0.014–1.344)	0.088
Need for MEP	52.9 (29.2–76.6)	56.3 (32.0–80.6)	0.849	RR: 0.222 (0.037–1.330)	0.099
Need for biological therapy	17.6 (0–35.7)	12.5 (0–28.7)	1.000	RR: 0.875 (0.222–3.451)	0.849
Days to IMV	5.5 [4.0–7.0]	7.5 [3.0–11.0]	0.866	HR: 0.300 (0.073–1.223)	0.093
Days to MEP	3 [3, 4]	2 [0–3]	0.029	HR: 1.102 (0.359–3.384)	0.864
Days to biological therapy	10 [4–10]	5 [2–8]	0.236	HR: 1.352 (0.230–7.921)	0.738
Days to MEP or biological therapy	3 [3, 4]	2 [0–3]	0.029	HR: 1.102 (0.359–3.384)	0.864
Safety outcomes
Adverse events	11.8 (0.0–27.1)	6.3 (0.0–18.2)	1.000	RR: 2.000 (0.163–24.484)	0.565
Days to adverse events	11.5 [NC-NC]	18 [NC-NC]	NC	HR: 1.869 (0.019–17.980)	0.588

Data are shown as rate % (95% confidence interval), median [interquartile range], risk ratio (95% confidence interval), and hazard ratio (95% confidence interval).
CI confidence interval; RR risk ratio; NC not calculable; ILD interstitial lung disease; IMV invasive mechanical ventilation; MEP methylprednisolone; HR hazard ratio.
*Denominator of 16 and 11 in cyclosporine A-standard of care group and in standard of care group, respectively. No data at 3 months on interstitial lung disease because the patients had died (6 patients).
Response without requiring IMV: The percentage of living patients whose interstitial lung disease did not persist 3 months after diagnosis of COVID-19 pneumonia and who did not require IMV during hospitalization.
Response requiring IMV: The percentage of living patients whose interstitial lung disease did not persist 3 months after diagnosis of COVID-19 pneumonia and who required IMV during hospitalization.
Response irrespective of the need for IMV: The percentage of living patients whose interstitial lung disease did not persist 3 months after diagnosis of COVID-19 pneumonia and who required and did not require IMV during hospitalization.

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