Trial RBR-5vpyh4
Publication Resende GG, medRxiv, 2021 (preprint)
Dates: 2020-09-01 to 2020-12-29
Funding: Mixed (Novartis Brazil; National Council for Scientific and Technological Development (CNPq))
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Brazil Follow-up duration (days): 28 | |
| Inclusion criteria | Adult patients (age ≥ 18 years); admitted to the hospital; SARS-CoV-2 infection confirmed by RT-PCR of nasopharyngeal swab and severe acute respiratory syndrome (SARS), according to the Brazilian Ministry of Health criteria (dyspnea / respiratory discomfort OR persistent chest pressure OR oxigen saturation less than 95% in room air OR cyanosis of lips or face) |
| Exclusion criteria | Functional classes III and IV of congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD); stages 4 and 5 of chronic kidney disease (GFR <30 mL/min); diabetic ketoacidosis; known history of HIV/AIDS infection or chronic or acute HBV or HCV infection; unrestrained bacterial or fungal co-infections (defined by hemodynamic instability, prior 48h of antimicrobial covering, or at the discretion of the study's medical coordinator); active tuberculosis; history of malignancy in the last year; current use (or in the previous 15 days) of other immunosuppressants; baseline neutrophils count ≤1000/mm3; pregnancy or breastfeeding |
| Interventions | |
| Treatment
Secukinumab 300 mg SC at day 0, second dose of 300 mg could be given at day 7 if enrollment criteria still met |
|
| Control
Standard care ( / ) Definition of Standard care: The standard of care in Hospital Risoleta Tolentino Neves, available to all patients, regardless of their allocation, during all the time of study execution, included antimicrobials (azithromycin and a beta-lactam, at the time of admission and until bacterial infection of the lungs could be excluded), corticosteroids (dexamethasone, 6mg daily, during ten days), and prophylactic anticoagulants (enoxaparin 40mg q12hr, except if thromboembolism was diagnosed, in which case full anticoagulation was performed). | |
| Participants | |
| Randomized 50 participants (n1=25 / n2= 25) | |
| Characteristics of participants N=50 Mean age : NR 26 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register Ventilator-free days at day 28 (VFD-28). | |
| In the report Ventilator-free days at day 28 (VFD-28). | |
| 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 pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. 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. A number of secondary outcomes in the registry were not reported (oxygen supplementary-free days on day 28; Sequential Organ Failure Assessment score; major vascular events - Myocardial Infarction / Encephalic Vascular Accident; hepatic failure - MELD score; neutropenia) and a number of secondary outcomes reported in the article were not in the registry (viral clearance; pulmonary thromboembolism, serious adverse events). |