Trial NCT04494984
Publication CT-INM005-01 - Lopardo G, EClinicalMedicine (2021) (published paper)
Dates: 2020-08-01 to 2020-10-26
Funding: Mixed (Inmunova; Ministries of Science and Production of Argentina)
Conflict of interest: Yes
Methods | |
RCT Blinding: double blinding | |
Location :
Multicenter / Argentina Follow-up duration (days): 28 | |
Inclusion criteria |
|
Exclusion criteria |
|
Interventions | |
Treatment
INM005 4 mg/kg IV infusion over fifty 50 minutes, on days 0 and 2 (48 hours between doses) |
|
Control
Placebo | |
Participants | |
Randomized participants : INM005=120 Placebo=125 | |
Characteristics of participants N= 245 Mean age : NR 157 males Severity : Mild: n=109 / Moderate: n=125 / Severe: n=7 Critical: n=0 | |
Primary outcome | |
In the register Clinical changes in COVID-19 symptoms [ Time Frame: 4 weeks ] The primary endpoint will be the proportion of patients who show a change in symptoms 28 days after the administration of the first dose. A responding subject is defined as a subject with improvement in at least 2 categories on the 8-point World Health Organization (WHO) ordinal scale of clinical status or a subject who is discharged. | |
In the report Proportion of patients that showed improvement 28 days after the administration of the first dose of at least two categories based upon the WHO ordinal clinical status scale or hospital discharge | |
Documents avalaible |
Protocol NR Statistical plan NR Data-sharing willing stated in the publication:
|
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 study registry was used in data extraction and risk of bias assessment. Neither study protocol nor statistical analysis plan was available. A supplementary appendix is referred to in the pre-print article, but this was not available. The study achieved the pre-specified target sample size. Efficacy outcomes used mITT which resulted in three fewer participants in the treatment group than the target sample size. Some laboratory measurements described as being done were not reported, but may be in the supplementary appendix. There is no change from the trial registration in the intervention and control treatments.
On 19th of April, 2021, this study was updated based on the published report. |