A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19.
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims to analyze the efficacy and safety of passive immunotherapy by administering
      an equine hyperimmune serum (INM005) against the SARS-CoV2 RBD to Covid19 patients.
      Improvement of the clinical course 28 days after the start of treatment will be evaluated.
    

Detailed description: 
      The pandemic caused by the new coronavirus has generated a situation unprecedented in recent
      history, with several million infected and hundreds of thousands of deaths. This disease is
      easily transmissible by air. Although a high percentage of cases present mild clinical
      presentation, approximately 15% of patients present moderate to severe cases and 5% require
      critical care, with respiratory assistance and a high risk of mortality. No effective
      therapies for the treatment or prevention of SARS.CoV2 have been identified yet. Preliminary
      evidence indicates that passive immunotherapy with convalescent plasma could alter the
      clinical course of this infection in a favorable manner. This strategy, even if confirmed as
      successful, requires voluntary donation by patients who have recovered, not all of whom are
      eligible as donors, since the antibody response varies in magnitude in different patients.
      This adaptive stage II/III study aims to analyze the efficacy and safety of passive
      immunotherapy by administering a purified Fab fraction of equine hyperimmune serum (INM005)
      generated from antigenic stimulation with the SARS-CoV2 RBD protein, with the objective of
      neutralizing the interaction of SARS-CoV-2 with its cellular receptor, thus preventing the
      multiplication of the virus. The safety of this type of equine hyperimmune sera has already
      been demonstrated in previous and ongoing protocols with a biologically equivalent product
      against the E. Coli shiga toxin to treat patients with Hemolytic Uremic Syndrome
      (CT-INM004-01 and CT-INM004-02). In the present study, eligible patients will with moderate
      to severe symptoms of COVID-19 that require hospitalization will receive two 4 mg/kg doses of
      INM005, two days apart, with the aim of improving the clinical course of COVID-19 28 days
      after the start of treatment with the study drug.
    

Intervention name(s): INM005; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.; Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study will be an adaptive phase 2/3 investigation. First, 12 subjects will be randomly assigned to receive 1 of the 2 treatment regimens (study drug or placebo) in a 1:1 ratio. After the first 6 subjects have been enrolled and have completed 24 hours post treatment of 2nd dose, the IDMC will review the safety data and will inform whether to continue with staggered enrollment. Randomization ratio for subjects in the following stage will be 1:1. The independent data monitoring committee (IDMC) will review safety data after 12, 24, 48 and 96 patients have been enrolled in each arm. The study will then enroll a total of 121 patients in each arm. An interim analysis will be performed after 80% of recruitment has been reached (n=194). The IDMC will analyze the rate of events in the group under "standard of care".
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment