Effectiveness and Safety Study of Specific Hyperimmune Equine Serum for the Treatment of Severe Hospitalized SARS-CoV-2 in Adults: Retrospective Cohort Study
Condition: Covid19
Study type: Observational

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.
    

Detailed description: 
      A classic retrospective cohort observational study of adult patients hospitalized for severe
      pneumonia with a diagnosis of SARS-CoV-2 will be conducted. The date of admission to the
      cohort will be considered the date of admission. All patients will be followed with
      structured evaluations at 14, 21 and 28 days.

      The cohort will be divided into two arms: a group of patients who received treatment with 2
      infusions of 4 mg / Kg each of hyperimmune anti-SARS-CoV-2 serum (INM005, CoviFab®) separated
      by 48 hours, from the date of approval for its use; and a group of patients not exposed to
      said intervention during hospitalization corresponding to the period prior to the approval of
      the hyperimmune anti-SARS-CoV-2 serum for its use. CoviFab® has been authorized under special
      conditions by the Agency for Medicines, Food and Medical Technology (ANMAT) for the treatment
      of hospitalized patients with moderate to severe disease caused by the SARS-CoV-2 virus
      (Regulation 9175/20, 22 December 2020)

      The study period that will be considered for the arm of patients exposed to anti-SARS-CoV-2
      polyclonal hyperimmune serum is between January 27, 2021 and April 9, 2021. The study period
      to include patients not exposed to hyperimmune anti-SARS-CoV-2 serum is between September 1,
      2020 to January 26, 2021. This last period was chosen because it is considered to be a time
      when there were no substantive differences in the diagnosis, categorization of risk, support
      measures or treatment of hospitalized adult patients with a confirmed diagnosis of COVID-19
      pneumonia, and therefore corresponds to a valid period for comparison.

      Although the "Escuela Hogar" Hospital began operating in July 2020, it was decided to exclude
      patients admitted for the first two months, considering that after two months of operation,
      the diagnostic, treatment and support systems are stable for the comparison between exposed
      and unexposed patients.

      The study will be carried out in a collaborative manner between the Acute Campaign Hospital
      "Escuela Hogar" and the Hospital Italiano de Buenos Aires, which will act as the coordinating
      center for this study.

      The Acute Campaign Hospital "Escuela Hogar" was designed and implemented to treat COVID-19
      cases exclusively. It was inaugurated in July 2020 in the city of Corrientes, Argentine
      Republic, with the aim of functioning as a diagnostic and treatment center for patients
      affected by COVID-19 throughout the province of Corrientes[4].

      It has a general hospitalization sector and a intensive care unit, with approximately 723
      total beds available and 300 in the intensive care unit. The staff includes doctors, nurses
      and health personnel, as well as technicians and administrators trained in the care of
      patients affected by COVID-19. It has an Operations Center where the members of the Crisis
      Committee monitor the entire building and access in real time, the status of patients and the
      movement of that institution.

      The hospital is paper free, and has a Computerized Medical Record. This data repository has
      additional information on patient admission, free text evolutions, structured indications,
      vital sign registration and support, and results of imaging studies reports such as X-rays
      and Tomography. The laboratory is in a different development that contains all the
      laboratories performed on each patient in each episode.

      The data processing and analysis will be carried out in the area of the Research Department
      of the Hospital Italiano de Buenos Aires.

      Variables Follow-up will be carried out with structured forms upon admission, days 14, 21 and
      28. For the purposes of the study, we will include demographic variables (age, sex, BMI),
      presence of comorbidities (hypertension, diabetes, obesity, cancer, lung disease, liver
      disease, kidney disease, coronary / cardiovascular disease), the history of having received
      plasma in the previous 30 days or during hospitalization, the plasma dose, Charlson score;
      related to the patient's diagnosis and their baseline status at admission (diagnostic method
      , date of onset of symptoms, respiratory rate, oxygen saturation, PaO2 / FiO2, oxygen
      requirement, type of device indicated, NEWS score) and related to the evolution both in
      hospitalization and after hospital discharge until day 28 from hospital admission (need for
      supplemental oxygen, admission to mechanical ventilation, admission to ICU, clinical
      improvement, disease progression, death, discharge).
    

Observational model: Cohort
Time perspective: Retrospective
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