ERRATUM: Evaluation of the initial response in clinical trial efforts for COVID-19 in Brazil

In the manuscript “Evaluation of the initial response in clinical trial efforts for COVID-19 in Brazil”, DOI: 10.1590/1980-549720200104, published in the Rev bras epidemiol. 2020; 23: e200104. On page 7, Table 1.

Where it reads:

Table 1.
Characteristics of COVID-19 research protocols in development in Brazil available at clinical trials registry databases until May 2020.

Interventions for the treatment or prophylaxis of COVID-19 (n=22)		n	(%)
Study design	Randomized clinical trial	18	(82)
	Non-randomized clinical trial	4	(18)
Trial phase	Phase 1	3	(14)
	Phase 2	5	(23)
	Phase 3	8	(36)
	Phase 4	2	(9)
	NM	4	(18)
Masking	Open-label	13	(59)
	Single-blind	1	(5)
	Double-blind	2	(9)
	Quadruple-blind	6	(27)
Control group	Placebo/standard treatment comparator	13	(59)
Multicentera	Yes	7	(32)
Recruitment site	Hospital	16	(73)
	Outpatient clinic	2	(9)
	NM	4	(18)
Power calculationb Scenario of large effect size RR = 0.4; incidence: 10 vs. 25%)	High ≥ 90%c	1	(5%)
	Good (< 90 and ≥ 80%)d	1	(5%)
	Low (< 80 and > 50%)e	2	(9%)
	Very low (< 50%)f	17	(81%)
Power calculationb Scenario of moderate effect size RR = 0.6; incidence: 7.2 vs. 12%)	High ≥ 90%g	11	(52%)
	Good (< 90 and ≥ 80%)h	1	(5%)
	Low (< 80 and > 50%)i	3	(14%)
	Very low (< 50%)j	6	(29%)
Interventions for the treatment of COVID-19 (n=21)
Inclusion criterion - COVID-19	Confirmed diagnosis (test+)	5	(24)
	Suspected diagnosis - Clinical suspicion or test+	12	(57)
	Suspected diagnosis - Clinical suspicion only	4	(19)
Severity of the patients included	Hospitalized - moderate or severe	4	(19)
	Hospitalized - severe	5	(24)
	Hospitalized - moderate	1	(5)
	Hospitalized - nonspecific	6	(28)
	Not hospitalized	1	(5)
	NM	4	(19)
Use of important outcomes for COVID-19k	As primary outcome	8	(38)
	Among secondary outcomes	18	(86)

• ^aMore that one recruitment center; ^bpower calculation did not include the study of the World Health Organization due to access limitations of the sample size in each arm; ^csample size (n) = 1,986; ^dn = 130; ^en between 400 and 1,000; ^fn between 20 and 600; ^gn between 630 and 1,968; ^hn between 200 and 290; ⁱn between 66 and 210; ^jn between 22 and 50; ^kimportant outcomes according to the consensus document published on the initiative Core Outcome Measures in Effectiveness Trials for hospitalized patients; NM: not mentioned; RR: relative risk.

It should read:

Table 1.
Characteristics of COVID-19 research protocols in development in Brazil available at clinical trials registry databases until May 2020.

Interventions for the treatment or prophylaxis of COVID-19 (n=22)		n	(%)
Study design	Randomized clinical trial	18	(82)
	Non-randomized clinical trial	4	(18)
Trial phase	Phase 1	3	(14)
	Phase 2	5	(23)
	Phase 3	8	(36)
	Phase 4	2	(9)
	NM	4	(18)
Masking	Open-label	13	(59)
	Single-blind	1	(5)
	Double-blind	2	(9)
	Quadruple-blind	6	(27)
Control group	Placebo/standard treatment comparator	13	(59)
Multicentera	Yes	7	(32)
Recruitment site	Hospital	16	(73)
	Outpatient clinic	2	(9)
	NM	4	(18)
Power calculationb Scenario of moderate effect size RR = 0.6; incidence: 7.2 vs. 12%)	High ≥ 90%c	1	(5%)
	Good (< 90 and ≥ 80%)d	1	(5%)
	Low (< 80 and > 50%)e	2	(9%)
	Very low (< 50%)f	17	(81%)
Power calculationb Scenario of large effect size RR = 0.4; incidence: 10 vs. 25%)	High ≥ 90%g	10	(48%)
	Good (< 90 and ≥ 80%)h	2	(9.5%)
	Low (< 80 and > 50%)i	2	(9.5%)
	Very low (< 50%)j	7	(33%)
Interventions for the treatment of COVID-19 (n=21)
Inclusion criterion - COVID-19	Confirmed diagnosis (test+)	5	(24)
	Suspected diagnosis - Clinical suspicion or test+	12	(57)
	Suspected diagnosis - Clinical suspicion only	4	(19)
Severity of the patients included	Hospitalized - moderate or severe	4	(19)
	Hospitalized - severe	5	(24)
	Hospitalized - moderate	1	(5)
	Hospitalized - nonspecific	6	(28)
	Not hospitalized	1	(5)
	NM	4	(19)
Use of important outcomes for COVID-19k	As primary outcome	8	(38)
	Among secondary outcomes	18	(86)

• ^aMore that one recruitment center; ^bpower calculation did not include the study of the World Health Organization due to access limitations of the sample size in each arm; ^csample size (n) = 1,986; ^dn = 130; ^en between 400 and 1,000; ^fn between 20 and 600; ^gn between 630 and 1,968; ^hn between 200 and 290; ⁱn between 66 and 210; ^jn between 22 and 50; ^kimportant outcomes according to the consensus document published on the initiative Core Outcome Measures in Effectiveness Trials for hospitalized patients; NM: not mentioned; RR: relative risk.

Publication Dates

• Publication in this collection
  24 May 2021
• Date of issue
  2021