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

NCT04954235 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 847

Last updated 2022-04-06

No results posted yet for this study

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

Sponsors & Collaborators

  • Hospital Italiano de Buenos Aires

    collaborator OTHER

  • Hospital de Campaña Escuela Hogar

    collaborator UNKNOWN

  • Laboratorio Elea Phoenix S.A.

    collaborator INDUSTRY

  • Instituto de Virologia Dr. Jose Maria Vanella

    collaborator UNKNOWN

  • Inmunova S.A.

    lead OTHER

Principal Investigators

  • Mariana Colonna, Bioch · Inmunova S.A.

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-22
Primary Completion
2021-09-09
Completion
2021-09-09

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954235 on ClinicalTrials.gov