CoviFab (equine hyperimmune serum) / Inmunova - LARVOL DELTA

Effectiveness and Safety Study of Specific Hyperimmune Equine Serum for the Treatment of Severe Hospitalized SARS-CoV-2 in Adults: Retrospective Cohort Study (clinicaltrials.gov) - P=N/A | N=847 | Completed | Sponsor: Inmunova S.A. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Non-clinical safety assessment and in vivo biodistribution of CoviFab, an RBD-specific F(ab')2 fragment derived from equine polyclonal antibodies. (PubMed, Toxicol Appl Pharmacol) - "CoviFab (INM005) is a RBD-specific F(ab')2 fragment derived from equine polyclonal antibodies...Nonclinical data of the current study confirm that CoviFab is safe, without observable adverse effects in mice. Furthermore, we confirm that bioimaging studies are a useful approach in preclinical trials to determine biodistribution."

Journal • Preclinical • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Effectiveness and Safety Study of Specific Hyperimmune Equine Serum for the Treatment of Severe Hospitalized SARS-CoV-2 in Adults: Retrospective Cohort Study (clinicaltrials.gov) - P; N=800; Recruiting; Sponsor: Inmunova S.A.

New trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

RBD-specific polyclonal F(ab´) fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial. (PubMed, EClinicalMedicine) - P2/3 | "we conducted a double-blind, randomized, placebo-controlled trial to assess efficacy and safety of EpAbs (INM005) in hospitalized adult patients with moderate and severe COVID-19 pneumonia in 19 hospitals of Argentina...Adverse events of special interest were mild or moderate; no anaphylaxis was reported. Albeit not having reached the primary endpoint, we found clinical improvement of hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease."

Clinical • Journal • P2/3 data • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19. (clinicaltrials.gov) - P2/3; N=242; Completed; Sponsor: Inmunova S.A.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19. (clinicaltrials.gov) - P2/3; N=242; Active, not recruiting; Sponsor: Inmunova S.A.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19. (clinicaltrials.gov) - P2/3; N=242; Recruiting; Sponsor: Inmunova S.A.

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease