Trial IRCT20180802040678N4
Publication Nouri-Vaskeh M, Int J Clin Pract, 2021 (published paper)
Dates: 2020-04-02 to 2020-06-30
Funding: Public/non profit (Tabriz University of Medical Sciences)
Conflict of interest: No
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Single center / Iran Follow-up duration (days): 30 | |
| Inclusion criteria | RT-PCR of oropharyngeal swab confirmed COVID-19; age 18 years and older; patients with primary hypertension with systolic blood pressure level of 130‐140 mmHg and diastolic blood pressure of 85‐90 mmHg managed by non‐pharmacological strategies or newly diagnosed |
| Exclusion criteria | Pregnant and lactating patients; severe hepatic and renal failure; bilateral renal artery stenosis; history of uncontrolled hypertension; patients showing losartan side effects such as cough exacerbation or increased potassium levels in blood; new anaemia; shock; reduction of blood pressure 90/60 mmHg or less |
| Interventions | |
| Treatment
Losartan 25 mg orally/nasogastric tube twice daily for at least 14 days |
|
| Control
Amlodipine ( / ) | |
| Participants | |
| Randomized 82 participants (n1=41 / n2= 41) | |
| Characteristics of participants N=82 Mean age : 63.7 41 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register Mortality 28 days, SOFA respiratory score 14 days, length of hospitalization, laboratory findings 14 days | |
| In the report 30‐days mortality and length of hospital stay between groups | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| 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 was used in data extraction and risk of bias assessment. Study protocol or statistical analysis plan were not available. The target sample size specified in the registry (n=100) was not achieved (n=82 were enrolled). There is no important change from the trial registry in the population, procedures, interventions, or outcomes, except it was described as unblinded in the registry but blinded in the published report. |