CovidResearchTrials by Shray Alag

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INM005Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug966 Ebselen Wiki 0.71
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D003141 Communicable Diseases NIH 0.08
D007239 Infection NIH 0.05
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Stage 2/3, Adaptive, Randomized, Controlled, Double-blind Study to Investigate the Pharmacokinetics, Efficacy and Safety of the Hyperimmune Equine Serum (INM005) in Adult Patients With Moderate to Severe Confirmed SARS-CoV2 Disease.

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.

NCT04494984 Covid19 Drug: INM005 Drug: Placebo

Primary Outcomes

Description: 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.

Measure: Clinical changes in COVID-19 symptoms

Time: 4 weeks

Secondary Outcomes

Description: INM005 product concentration in serum at different time points after dosing

Measure: Pharmacokinetics evaluation of INM005

Time: 1 week

Description: Time to achieve a change in at least 2 categories on the 8-point WHO ordinal scale of clinical status. Time to discharge (days). Time to intensive care unit (ICU) discharge (days).

Measure: Time to progression of disease

Time: 4 weeks

Description: Proportion of patients who present change in at least 2 categories on the 8-point WHO ordinal scale of clinical status at 7 and 14 days after the start of the treatment.

Measure: Disease progression

Time: up to 2 weeks

Description: Proportion of patients discharged at 28 days

Measure: Discharge

Time: up to 4 weeks

Description: Proportion of patients who require ICU hospitalization

Measure: Intensive care unit (ICU) hospitalization

Time: up to 4 weeks

Description: Proportion of patients who require MVA

Measure: Mechanical ventilation assistance (MVA)

Time: up to 4 weeks

Description: Proportion of patients who die due to complications from COVID19

Measure: Mortality

Time: up to 4 weeks

Description: Change in viral load from baseline to 7 and 21 days after the start of the treatment.

Measure: Changes in viral load

Time: up to 3 weeks

Other Outcomes

Description: Measurement of anti SARS-CoV2 antibodies titer levels. IgG (0, 21 days)

Measure: Anti SARS-CoV2 antibodies levels

Time: 3 weeks

Description: Changes in Troponin T levels will be evaluated at 7 and 21 days as a measurement of disease progression

Measure: Changes in Troponin T levels

Time: 3 weeks

Description: Changes in D-dimer levels will be evaluated at 7 and 21 days as a measurement of disease progression

Measure: Changes in D-dimer levels

Time: 3 weeks

Description: Changes in Ferritin levels will be evaluated at 7 and 21 days as a measurement of disease progression

Measure: Changes in Ferritin levels

Time: 3 weeks

Description: Changes in LDH levels will be evaluated at 7 and 21 days as a measurement of disease progression

Measure: Changes in LDH levels

Time: 3 weeks

Description: Changes in C-reactive protein levels will be evaluated at 7 and 21 days as a measurement of disease progression

Measure: Changes in C-reactive protein levels

Time: 3 weeks

Description: Measurement of anti-INM005 antibodies: baseline and 21 days

Measure: Immunogenicity

Time: 3 weeks

No related HPO nodes (Using clinical trials)