Trial *
Publication Moreira TG, 2021 (published paper)
Funding: Private (Tiziana Life Sciences )
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Brazil Follow-up duration (days): 13 | |
| Inclusion criteria | Positive RT-PCR COVID test; mild to moderate disease with an oxygen saturation over 93% and no requirement for oxygen |
| Exclusion criteria | Infectious disease: syphilis, hepatitis and HIV; Pregnancy; less than 18 years old; chronic kidney disease; cancer or other immunodeficiencies; elevated glycated hemoglobin for patients with diabetes |
| Interventions | |
| Treatment 1 Foralumab | |
| Control Standard care | |
| Treatment 3 Foralumab+Dexamethasone | |
| Participants | |
| Randomized 39 participants n1=12/ n2=16/ n3=11 | |
| Characteristics of participants N=39 Mean age : 39 14 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register NR | |
| In the report NR | |
| 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 |
High |
| General comment | The registry and protocol were not available for data extraction and risk of bias assessment. Study dates not reported. This was a pilot study and it is unclear whether any target sample size was defined. The study was assessed to be at a high risk of bias due to some concerns in four of five domains. |