Covid-19 Living Data

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	Hospitalized adult patients Positive reverse-transcriptase-polymerase-chain reaction (RT-PCR) for SARS-CoV-2 Were between 18 and 79 years old Within 10 days from the initiation of symptoms Were hospitalized with a diagnosis of moderate or severe COVID-19 disease Provided a voluntary undelegated written informed consent
Exclusion criteria	Pregnant women or during lactation period History of treatment with SARS-CoV-2 convalescent plasma Participation in other therapeutic clinical trial for COVID-19 History of anaphylaxis Severe allergic reaction to equine sera or to contact or exposure to horse proteins Hospitalization in ICU and/or requirement of mechanical ventilation Likelihood of death due to clinical reasons other than COVID-19 within the following 30 days Expected transfer to other healthcare institution.
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 Number of vaccinated participants: NR
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 available	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.