Table 4. Open in new tab Baseline...

Test and Outcome	Positive	Negative	Unadjusted	Adjusted for Baseline Oxygen	Adjusted for Log₁₀ Ag
LumiraDx
Sustained recovery
Sustained recovery	66	(84.6)	29	(60.4)	1.89 (1.24–2.89)	.003	2.59 (1.67–4.03)	<.001	1.60 (1.08–2.38)	.020
Censored	6	(7.7)	7	(14.6)	…		…		…	…
Died before recovered	6	(7.7)	12	(25.0)	…		…		…	…
Died	7	(9.0)	14	(29.2)	0.25 (.10–.63)	.003	0.20 (.08–.52)	<.001	0.30 (.12–.78)	.013
Primary safety composite
Day 5	14	(17.9)	16	(33.3)	0.43 (.18–1.00)	.049	0.25 (.09–.68)	.007	0.54 (.22–1.31)	.175
Day 28	23	(29.5)	28	(58.3)	0.29 (.13–.63)	.002	0.09 (.03–.29)	<.001	0.36 (.16–.82)	.014
Day 90	21	(26.9)	29	(60.4)	0.23 (.10–.49)	<.001	0.04 (.01–.16)	<.001	0.27 (.12–.61)	.002
No. of participants	78	48	…	…	…		…	…
RightSign
Sustained recovery
Sustained recovery	59	(81.9)	36	(66.7)	1.65 (1.13–2.41)	.009	2.15 (1.43–3.23)	<.001	1.43 (.99–2.06)	.060
Censored	7	(9.7)	6	(11.1)	…		…		…	…
Died before recovered	6	(8.3)	12	(22.2)	…		…		…	…
Died	7	(9.7)	14	(25.9)	0.33 (.13–.82)	.016	0.29 (.11–.75)	.011	0.42 (.16–1.05)	.064
Primary safety composite
Day 5	11	(15.3)	19	(35.2)	0.33 (.14–.78)	.012	0.21 (.08–.57)	.002	0.41 (.17–.98)	.046
Day 28	20	(27.8)	31	(57.4)	0.29 (.13–.60)	.001	0.12 (.04–.34)	<.001	0.35 (.16–.78)	.010
Day 90	18	(25.0)	32	(59.3)	0.23 (.11–.49)	<.001	0.07 (.02–.22)	<.001	0.27 (.12–.60)	.001
No. of participants	72	54	…	…	…		…	…

Test and Outcome

Positive

Negative

Unadjusted

Adjusted for Baseline Oxygen

Adjusted for Log₁₀ Ag

No.

(%)

No.

(%)

RRR/HR/OR^a (95% CI)

P Value

RRR/HR/OR^a (95% CI)

P Value

RRR/HR/OR^a (95% CI)

P Value

LumiraDx

Sustained recovery

(84.6)

(60.4)

1.89 (1.24–2.89)

.003

2.59 (1.67–4.03)

<.001

1.60 (1.08–2.38)

.020

Censored

(7.7)

(14.6)

…

Died before recovered

(7.7)

(25.0)

…

Died

(9.0)

(29.2)

0.25 (.10–.63)

.003

0.20 (.08–.52)

<.001

0.30 (.12–.78)

.013

Primary safety composite

Day 5

(17.9)

(33.3)

0.43 (.18–1.00)

.049

0.25 (.09–.68)

.007

0.54 (.22–1.31)

.175

Day 28

(29.5)

(58.3)

0.29 (.13–.63)

.002

0.09 (.03–.29)

<.001

0.36 (.16–.82)

.014

Day 90

(26.9)

(60.4)

0.23 (.10–.49)

<.001

0.04 (.01–.16)

<.001

0.27 (.12–.61)

.002

No. of participants

…

RightSign

Sustained recovery

(81.9)

(66.7)

1.65 (1.13–2.41)

.009

2.15 (1.43–3.23)

<.001

1.43 (.99–2.06)

.060

Censored

(9.7)

(11.1)

…

Died before recovered

(8.3)

(22.2)

…

Died

(9.7)

(25.9)

0.33 (.13–.82)

.016

0.29 (.11–.75)

.011

0.42 (.16–1.05)

.064

Primary safety composite

Day 5

(15.3)

(35.2)

0.33 (.14–.78)

.012

0.21 (.08–.57)

.002

0.41 (.17–.98)

.046

Day 28

(27.8)

(57.4)

0.29 (.13–.60)

.001

0.12 (.04–.34)

<.001

0.35 (.16–.78)

.010

Day 90

(25.0)

(59.3)

0.23 (.11–.49)

<.001

0.07 (.02–.22)

<.001

0.27 (.12–.60)

.001

No. of participants

…

Test and Outcome	Positive	Negative	Unadjusted	Adjusted for Baseline Oxygen	Adjusted for Log₁₀ Ag
LumiraDx
Sustained recovery
Sustained recovery	66	(84.6)	29	(60.4)	1.89 (1.24–2.89)	.003	2.59 (1.67–4.03)	<.001	1.60 (1.08–2.38)	.020
Censored	6	(7.7)	7	(14.6)	…		…		…	…
Died before recovered	6	(7.7)	12	(25.0)	…		…		…	…
Died	7	(9.0)	14	(29.2)	0.25 (.10–.63)	.003	0.20 (.08–.52)	<.001	0.30 (.12–.78)	.013
Primary safety composite
Day 5	14	(17.9)	16	(33.3)	0.43 (.18–1.00)	.049	0.25 (.09–.68)	.007	0.54 (.22–1.31)	.175
Day 28	23	(29.5)	28	(58.3)	0.29 (.13–.63)	.002	0.09 (.03–.29)	<.001	0.36 (.16–.82)	.014
Day 90	21	(26.9)	29	(60.4)	0.23 (.10–.49)	<.001	0.04 (.01–.16)	<.001	0.27 (.12–.61)	.002
No. of participants	78	48	…	…	…		…	…
RightSign
Sustained recovery
Sustained recovery	59	(81.9)	36	(66.7)	1.65 (1.13–2.41)	.009	2.15 (1.43–3.23)	<.001	1.43 (.99–2.06)	.060
Censored	7	(9.7)	6	(11.1)	…		…		…	…
Died before recovered	6	(8.3)	12	(22.2)	…		…		…	…
Died	7	(9.7)	14	(25.9)	0.33 (.13–.82)	.016	0.29 (.11–.75)	.011	0.42 (.16–1.05)	.064
Primary safety composite
Day 5	11	(15.3)	19	(35.2)	0.33 (.14–.78)	.012	0.21 (.08–.57)	.002	0.41 (.17–.98)	.046
Day 28	20	(27.8)	31	(57.4)	0.29 (.13–.60)	.001	0.12 (.04–.34)	<.001	0.35 (.16–.78)	.010
Day 90	18	(25.0)	32	(59.3)	0.23 (.11–.49)	<.001	0.07 (.02–.22)	<.001	0.27 (.12–.60)	.001
No. of participants	72	54	…	…	…		…	…

Table 4.

Open in new tab

Baseline Antibody Status and Outcomes in the Therapeutics for Inpatients with COVID-19 (TICO) Trial

Test and Outcome	Positive		Negative		Unadjusted		Adjusted for Baseline Oxygen		Adjusted for Log₁₀ Ag
Test and Outcome	No.	(%)	No.	(%)	RRR/HR/OR^a (95% CI)	P Value	RRR/HR/OR^a (95% CI)	P Value	RRR/HR/OR^a (95% CI)	P Value
LumiraDx
Sustained recovery
Sustained recovery	66	(84.6)	29	(60.4)	1.89 (1.24–2.89)	.003	2.59 (1.67–4.03)	<.001	1.60 (1.08–2.38)	.020
Censored	6	(7.7)	7	(14.6)	…		…		…	…
Died before recovered	6	(7.7)	12	(25.0)	…		…		…	…
Died	7	(9.0)	14	(29.2)	0.25 (.10–.63)	.003	0.20 (.08–.52)	<.001	0.30 (.12–.78)	.013
Primary safety composite
Day 5	14	(17.9)	16	(33.3)	0.43 (.18–1.00)	.049	0.25 (.09–.68)	.007	0.54 (.22–1.31)	.175
Day 28	23	(29.5)	28	(58.3)	0.29 (.13–.63)	.002	0.09 (.03–.29)	<.001	0.36 (.16–.82)	.014
Day 90	21	(26.9)	29	(60.4)	0.23 (.10–.49)	<.001	0.04 (.01–.16)	<.001	0.27 (.12–.61)	.002
No. of participants	78		48		…	…	…		…	…
RightSign
Sustained recovery
Sustained recovery	59	(81.9)	36	(66.7)	1.65 (1.13–2.41)	.009	2.15 (1.43–3.23)	<.001	1.43 (.99–2.06)	.060
Censored	7	(9.7)	6	(11.1)	…		…		…	…
Died before recovered	6	(8.3)	12	(22.2)	…		…		…	…
Died	7	(9.7)	14	(25.9)	0.33 (.13–.82)	.016	0.29 (.11–.75)	.011	0.42 (.16–1.05)	.064
Primary safety composite
Day 5	11	(15.3)	19	(35.2)	0.33 (.14–.78)	.012	0.21 (.08–.57)	.002	0.41 (.17–.98)	.046
Day 28	20	(27.8)	31	(57.4)	0.29 (.13–.60)	.001	0.12 (.04–.34)	<.001	0.35 (.16–.78)	.010
Day 90	18	(25.0)	32	(59.3)	0.23 (.11–.49)	<.001	0.07 (.02–.22)	<.001	0.27 (.12–.60)	.001
No. of participants	72		54		…	…	…		…	…

Test and Outcome	Positive		Negative		Unadjusted		Adjusted for Baseline Oxygen		Adjusted for Log₁₀ Ag
Test and Outcome	No.	(%)	No.	(%)	RRR/HR/OR^a (95% CI)	P Value	RRR/HR/OR^a (95% CI)	P Value	RRR/HR/OR^a (95% CI)	P Value
LumiraDx
Sustained recovery
Sustained recovery	66	(84.6)	29	(60.4)	1.89 (1.24–2.89)	.003	2.59 (1.67–4.03)	<.001	1.60 (1.08–2.38)	.020
Censored	6	(7.7)	7	(14.6)	…		…		…	…
Died before recovered	6	(7.7)	12	(25.0)	…		…		…	…
Died	7	(9.0)	14	(29.2)	0.25 (.10–.63)	.003	0.20 (.08–.52)	<.001	0.30 (.12–.78)	.013
Primary safety composite
Day 5	14	(17.9)	16	(33.3)	0.43 (.18–1.00)	.049	0.25 (.09–.68)	.007	0.54 (.22–1.31)	.175
Day 28	23	(29.5)	28	(58.3)	0.29 (.13–.63)	.002	0.09 (.03–.29)	<.001	0.36 (.16–.82)	.014
Day 90	21	(26.9)	29	(60.4)	0.23 (.10–.49)	<.001	0.04 (.01–.16)	<.001	0.27 (.12–.61)	.002
No. of participants	78		48		…	…	…		…	…
RightSign
Sustained recovery
Sustained recovery	59	(81.9)	36	(66.7)	1.65 (1.13–2.41)	.009	2.15 (1.43–3.23)	<.001	1.43 (.99–2.06)	.060
Censored	7	(9.7)	6	(11.1)	…		…		…	…
Died before recovered	6	(8.3)	12	(22.2)	…		…		…	…
Died	7	(9.7)	14	(25.9)	0.33 (.13–.82)	.016	0.29 (.11–.75)	.011	0.42 (.16–1.05)	.064
Primary safety composite
Day 5	11	(15.3)	19	(35.2)	0.33 (.14–.78)	.012	0.21 (.08–.57)	.002	0.41 (.17–.98)	.046
Day 28	20	(27.8)	31	(57.4)	0.29 (.13–.60)	.001	0.12 (.04–.34)	<.001	0.35 (.16–.78)	.010
Day 90	18	(25.0)	32	(59.3)	0.23 (.11–.49)	<.001	0.07 (.02–.22)	<.001	0.27 (.12–.60)	.001
No. of participants	72		54		…	…	…		…	…

Abbreviations: Ag, antigen; CI, confidence interval; HR, hazard ratio; OR, odds ratio; RRR, recovery rate ratio.

^aAntibody-positive versus antibody-negative RRR (recovery), HR (death), OR (safety endpoints) adjusted for or stratified by Therapeutics for Inpatients with COVID-19 (TICO) trial.

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