Trial IRCT20151113025025N3
Publication Najmeddin F, Am J Hypertens, 2021 (published paper)
Dates: 2020-04-01 to 2020-09-30
Funding: Public/non profit (Tehran University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: triple blinding
Location : Multicenter / Iran
Follow-up duration (days): 93
Inclusion criteriaAdult patients (18 year or older);
previously diagnosed essential hypertension consuming angiotensin-converting enzyme inhibitors or angiotensin receptor blockers;
definite diagnosis of COVID-19 (positive oro/nasopharyngeal real-time polymerase chain reaction (PCR) and moderate to severe involvement of COVID-19 in their chest computed tomography scan according to the World Health Organization's interim guidance and national guidelines)
Exclusion criteriaUncontrolled hypertension with systolic blood pressure (BP) more than 180 mmHg or diastolic BP more than 120 mmHg;
past history of congestive heart failure or arrhythmia of various severity;
sensitivity to the newly prescribed medications;
a history of severe asthma; a history of known depression;
consuming medications with interactions such as lithium, antiepileptic drugs, chemotherapy;
the treating physician’s concern or patient unwillingness to enter the study;
patients whose prognosis is influenced by another disease;
pregnancy or breastfeeding, and unstable vital signs (systolic blood pressure <90 mmHg;
pulse rate<50 or >150 beats/min).
Interventions
Treatment
Continue ARB/ACEI
Continuation of ACE inhibitors or ARBs with the previous dose orally for 14 days unless mandating adjustment to control blood pressure.
Control
Discontinue ARB/ACEI ( / )
Participants
Randomized
66 participants (n1=33 / n2= 33)
Characteristics of participants
N=66
Mean age : 66.3
30 males
Severity : Mild: n=0 / Moderate: n=20/ Severe: n=40 Critical: n=5
Primary outcome
In the register
Death [3 months]
In the report
Length of stay in the hospital and ICU
Documents
available

Protocol

NR

Statistical plan

NR

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 supplementary materials were used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available at time of extraction. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. Of the outcomes reported in the article, only mortality and ICU admission were included in the registry. The primary outcomes in the article (length of stay in the hospital and ICU) do not reflect the primary outcome in the registry (number of deceased patients at 3 months). The study was updated on the 24th of November, 2021 after data acquired from contact with authors.