Table 2 Efficacy and safety at day 11 (ANRS COV01 INTENSE-COV).

n%	LPVr N = 96	LPVr + TLM N = 96	LPVr + ATV N + 98	LPVr vs LPVr + TLM / ATV p-values¹
Primary endpoint – VIRO-inflammatory success
Ct ≥ 40
Yes	45 (58)	45 (55)	42 (57)	0.66 / 0.84
No	32 (42)	37 (35)	32 (43)
Missing	19	18	24
Primary analysis – missing imputed by failure
Ct ≥ 40 and CRP < 27 mg/L	44 (46)	43 (43)	42 (43)	0.69 /0.68
Sensitivity analysis – intention to treat, complete case
Ct ≥ 40 and CRP < 27 mg/L
Yes	44 (57)	43 (52)	42 (57)	0.56 / 0.97
No	33 (43)	39 (48)	32 (43)
Missing	19	18	24
Sensitivity analysis – intention to treat, complete case, CT threshold = 33
Ct ≥ and CRP < 27 mg/L	46 (48)	43 (43)	44 (45)	0.49 /0.68
Secondary endpoints – clinical status and advers events
WHO-OSCI
Ambulatory mild disease	82 (85)	91 (91)	83 (85)	0.40 / 0.79
No activities limitation	52 (54)	61 (61)	65 (66)	0.34 / 0.09
At least one adverse event of any type and severity	36 (38)	47 (47)	55 (56)	0.18 / 0.01
Worsening, hospitalization or death	5 (5)	5 (5)	3 (3)	0.94 / 0.45
Death	3 (3)		1 (1)	0.12 /0.37

LPVr lopinavir/ritonavir, TLM telmisartan, ATV atorvastatin, Ct number of cycles in the SARS-CoV2 RT-PCR, CRP C-reactive protein.
¹First p-value: LPV/r vs LPV/r + TLM; second p-value: LPV/r vs LPV/r + ATV.
²The national recommendations changed during trial progress: the day 11 Ct measure was no longer mandatory for recovered patients. Therefore, the investigators stopped prescribing it for trial patients in that case despite trial protocol, leading to a missing primary endpoint for 41 patients. When the trial team discovered this, it reinstated the systematic day 11 Ct measure in the trial. The DSMB approved the proposition of a post hoc analysis with day 7 Ct value carried forward to day 11 for the 41 patients, and missing data imputed by failure for the others.

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