Trial NCT04364893
Publication Lopes RD, JAMA, 2021 (published paper)
Dates: 2020-04-09 to 2020-06-26
Funding: Not reported/unclear
Conflict of interest: Yes
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Multicenter / Brazil Follow-up duration (days): 30 | |
| Inclusion criteria | 1. Patients aged ≥18 years hospitalized with a confirmed diagnosis of COVID-19 under use of angiotensin receptor blockers or angiotensin converting enzyme inhibitors;
2. The patient (or legal representative) must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations. |
| Exclusion criteria | 1. Hospitalization due to decompensated heart failure in the last 12 months; 2. Use of more than 3 anti-hypertensive drugs; 3. Use of Sacubitril/Valsartan; 4. Patients under mechanical ventilation; 5. Hemodynamic instability in the first 24 hours until the moment of confirmed diagnosis of COVID-19; acute renal failure; shock; 6. Pregnancy |
| Interventions | |
| Treatment
Discontinue ARB/ACEI (*/ )Co-Intervention: Standard care Duration : |
|
| Control
Continue ARB/ACEI | |
| Participants | |
| Randomized 740 participants (n1=371 / n2= 369) | |
| Characteristics of participants N=740 Mean age : NR 393 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=283 Critical: n=0 | |
| Primary outcome | |
| In the register Median days alive and out of the hospital [Time Frame: 30 days] | |
| In the report Number of days alive and out of the hospital through 30 days | |
| Documents available |
Protocol Yes. In English Statistical plan NR Data-sharing stated No |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Low |
| General comment | In addition to the published article, the trial registry and study protocol and supplemantary materials were used in data extraction and risk of bias assessment. Serious adverse events (not covered by the study-specific adverse outcome) were included as an outcome in the protocol but were not reported. There were no other substantive differences between the published paper and the trial registry, protocol and published article. The study achieved it pre-stated target sample size. However, the number of patients eventually included in the final study report was lower than the target sample size because the investigators discovered that at one site the coordinator had recruited patients without consent and had falsified data, necessitating their removal and verification of all remaining included data. |