Trial RBR-8969zg
Publication Garcia de Alencar JC, CID, 2020 (published paper)
Dates: 2020-04-10 to 2020-05-25
Funding: Public/non profit (Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP))
Conflict of interest: No
| Methods | |
| RCT Blinding: | |
| Location :
Single center / Brazil Follow-up duration (days): * | |
| Inclusion criteria | Patients 18 years of age or older diagnosed with severe acute respiratory syndrome by Covid-19 (suspected or confirmed) were eligible for the study. Inclusion criteria were an oxygen saturation (SaO2) of 94% or less while breathing ambient air and respiratory rate higher than 24 breaths/min. |
| Exclusion criteria | Exclusion criteria included known allergy or hypersensitivity to N-acetylcysteine, signs of the imminent need for orotracheal intubation (SaO2 < 90% with supplemental oxygen, increased respiratory effort, decreased level of consciousness), pregnancy or refusal to sign the written consent. |
| Interventions | |
| Treatment
N-acetylcysteine 14g diluted in 500 mL dextrose 5% IV for the first 4 hours, followed by 7g diluted in 500 mL dextrose 5% IV for the next 16 hours. |
|
| Control
Placebo Duration : 20 hours | |
| Participants | |
| Randomized 140 participants (n1=70 / n2= 70) | |
| Characteristics of participants N=140 Mean age : NR 80 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register Reduction in in-hospital mortality in 5%, verified by medical record analysis, in patients receiving N-acetylcysteine compared to the group receiving Placebo | |
| In the report The primary clinical endpoint was the necessity for intubation and mechanical ventilation. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated NR |
| 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 |
* |
| General comment |
This study is pending for author reply. The manuscript doesn't report follow up time or timepoint for the outcomes assessed.
In addition to all available versions of the published article, the study registry was used in data extraction and risk of bias assessment. The target sample size specified in the registry was not achieved. The primary outcome in the registry is reported as secondary in the manuscript. Also the primary outcome in the manuscript appears as secondary in the registry.The intervention dose in the registry is expressed in mg per KG, whereas in the manuscript is a fixed dose. |