Trial NCT04353596
Publication Bauer A, Lancet , 2021 (published paper)
Dates: 2020-04-20 to 2021-01-20
Funding: Public/non profit (Austrian Science Fund; German Center for
Cardiovascular Research)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Multicenter / Austria, Germany Follow-up duration (days): 30 | |
| Inclusion criteria | Female and male patients competent to make a decision; 18 years or older; recent symptomatic SARS-CoV-2 infection; positive RT-PCR test result within the last 5 days; chronic treatment with ACEIs or ARBs for any indication for treatment of arterial hypertension, diabetes, heart failure, or coronary artery disease for at least 1 month before study inclusion; stable haemodynamic conditions (systolic arterial blood pressure <180 mm Hg). |
| Exclusion criteria | Women capable of bearing children as well as pregnant and breastfeeding women; participant in another interventional trail; acute coronary syndrome within the last 3 months;At screening visit, no oral medication intake possible; severe arterial hypertension requiring more than four antihypertensive drugs; New York Heart Association class III or IV owing to severe heart failure; left ventricular ejection fraction <30% or NTproBNP ≥600 pg/mL in combination with clinical signs of heart failure;substitution of ACEI or ARB with another class of drug was deemed impossible to do ambulatory blood pressure monitoring; Acute respiratory distress syndrome with need for mechanical ventilation; Patients who cannot be switched to an alternative medication |
| Interventions | |
| Treatment
Continue ARB/ACEI The dosage is carried out according to the recommendations given in the approval conditions of the respective drug. |
|
| Control
Discontinue ARB/ACEI ( / ) | |
| Participants | |
| Randomized 216 participants (n1=107 / n2= 109) | |
| Characteristics of participants N=216 Mean age : 72.5 129 males Severity : Mild: n=103 / Moderate: n=81/ Severe: n=5 Critical: n=0 | |
| Primary outcome | |
| In the register Combination of maximum Sequential Organ Failure Assessment (SOFA) Score and death [ Time Frame: 30 days ] The minimal value of the SOFA Score will be 0 and the maximal value 24 points. All-cause death is classified as the maximum score (24 points). In case of a subclinical disease progress without need for hospitalization, the SOFA score will be 0. Composite of admission to an intensive care unit (ICU), the use of mechanical ventilation, or all-cause death [ Time Frame: 30 days ] will be hierarchically tested after enrollment of 798 patients | |
| In the report Composite of the maximum sequential organ failure assessment (SOFA) score and death within 30 days | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated
|
| 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 |
Some concerns |
| General comment |
In addition to the published article, the study registry and protocol were used in data extraction and risk of bias assessment. The study nearly achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome does reflect the reported primary outcome.
On 30th July, 2021, we received additional information from authors on this study. This study was updated with data from contact with authors on August 17th, 2021. |