Effectiveness and Safety Study of Specific Hyperimmune Equine Serum for the Treatment of Severe Hospitalized SARS-CoV-2 in Adults: Retrospective Cohort Study

NCT04954235 | Completed

• 1 other identifier: 4484
• Study Type: observational
• Target: 847
• Locations: 1 country
• Sites: 1

Brief Summary

An observational, retrospective, classic cohort study of adult patients hospitalized for severe pneumonia with a diagnosis of SARS-CoV-2 by RT-PCR will be carried out. The cohort will be divided into two arms: a group of patients who received treatment with anti-SARS-CoV-2 hyperimmune serum and a group of patients not exposed to the intervention during hospitalization corresponding to the period prior to the approval of the anti-hyperimmune serum SARS-CoV-2 for use. All patients will be have structured follow-up at 14, 21 and 28 days, until discharge or death.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Mortality at day 28

  Proportion of patients who die at 28th day since hospital admission date

  28th day since hospital admission date

Secondary Outcomes (10)

• Mortality at days 14 and 21 after hospital admission.

  14th and 21st days since hospital admission date

• Ordinal clinical scale at days 14, 21 and 28

  14th, 21st and 28th days since hospital admission date

• Hospital discharge at days 14, 21 and 28.

  14th, 21st and 28th days since hospital admission date

• Time to hospital discharge

  Time to hospital discharge since hospital admission date in a 28 days follow up period

• Patients admitted to Intensive Care Unit.

  28 days follow up period since hospital admission date

Study Arms (2)

Exposed to Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F[ab']2 fragments

Group of patients with severe pneumonia who received treatment with 2 infusions of 4 mg / Kg each of hyperimmune anti-SARS-CoV-2 serum (INM005, CoviFab®) separated by 48 hours

Not Exposed to Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F[ab']2 fragments

Group of patients with severe pneumonia not exposed to hyperimmune anti-SARS-CoV-2 serum (INM005, CoviFab®) during hospitalization corresponding to the period prior to the approval of the hyperimmune anti-SARS-CoV-2 serum for its use.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients younger than 80 years hospitalized at the "Escuela Hogar" Hospital in Corrientes, Argentina, for severe pneumonia diagnosed with SARS-CoV-2

You may qualify if:

• Patients older than 18 years and younger than 80 years.
• Hospitalized for COVID-19 at the "Escuela Hogar" Hospital in Corrientes, Argentina from September 2020 to April 2021.
• Confirmed diagnosis of COVID-19 by SARS-CoV-2 Antigen Test or qualitative reverse transcriptase-polymerase chain reaction (qRT-PCR -GeneoDX Co, Ltd or similar) or Dosage of anti-SARS-CoV-2 IgG / IgM antibodies
• Who received hyperimmune anti-SARS-CoV-2 serum according to the indication approved by ANMAT for use after the approval date (January 2021 to April 2021) or Patients with the same indication corresponding to the period prior to the approval date (September 2020 to January 2020)
• With severe disease defined as individuals with tachypnea\> 30 breaths per minute or oxygen saturation \<94% ambient air or PaO2 / FiO2 \<300, or pulmonary infiltrates\> 50% on chest image.

You may not qualify if:

• Asymptomatic disease (individuals with a positive test for SARS-CoV-2, but who do not have symptoms), mild (individuals who have compatible symptoms, but without dyspnea and with a normal chest imaging study), moderate (individuals with evidence of lower respiratory tract disease on clinical or imaging evaluation, and oxygen saturation\> = 94% room air) or critical (those with respiratory failure, septic shock, and / or multi-organ dysfunction).
• Patients who received anti-SARS-CoV-2 hyperimmune serum off-label approved by ANMAT for use according to Regulation 9175/20.
• Pregnant women.
• Lactating women.
• Patients who are on mechanical ventilation or admitted to the ICU at hospital admission.
• Confirmation of another concomitant microbiological cause of pneumonia other than COVID-19

Sponsors & Collaborators

• Inmunova S.A.: lead
• Hospital Italiano de Buenos Aires: collaborator
• Hospital de Campaña Escuela Hogar: collaborator
• Laboratorio Elea Phoenix S.A.: collaborator
• Instituto de Virologia Dr. Jose Maria Vanella: collaborator

Study Sites (1)

Hospital de Campaña "Escuela Hogar"

Corrientes, Argentina

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mariana Colonna, Bioch

  Inmunova S.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 8, 2021
• Study Start: May 22, 2021
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

AR (1)