Status:
UNKNOWN
Safety and Effectiveness of an Immunobiological Drug in CoViD-19
Lead Sponsor:
Administracion Nacional de Laboratorios e Institutos de Salud Dr. Carlos G. Malbran
Conditions:
COVID-19 Pneumonia
COVID-19 Respiratory Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The aims of this study is to analyze the efficacy and safety of a passive immunotherapy strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National Institute for the Pr...
Detailed Description
This is an adaptive phase II/III study that aims to analyze the efficacy and safety of a immunobiological drug (Anti SARS-CoV-2) in the treatment of CoViD-19. This treatment is a passive immunotherapy...
Eligibility Criteria
Inclusion
- Subjects over 18 years old and under 80 years old.
- Positive results by RT-PCR for SARS CoV-2
- Clinical picture compatible with respiratory compromise in the form of pneumonia attributed to COVID-19 (Stage 3, 4 or 5 according to the WHO scale), lasting up to 72 hours from the onset of symptoms to their evaluation to be incorporated into the study.
- Patient with good disposition towards the study and that signs the informed consent.
Exclusion
- Patients with clinical disease corresponding to mild / asymptomatic forms (Absence of radiological infiltrate and risk factors, with normal auscultation and arterial saturation of oxygen (SatO2) greater than 95%)
- Patients with clinical disease corresponding to severe forms (Severe pneumonia: presence of severity criteria (ATS / IDSA), one of two major or three minor criteria.)
- Patients who have received other therapeutic strategies in the framework of an experimental study that make it difficult to evaluate the results obtained, including (but not limited to): convalescent plasma, lopinavir / ritonavir, hydroxychloroquine, and azithromycin.
- Pregnant or lactating women.
- Women of childbearing potential not using an effective contraceptive method (withdrawal, intrauterine device, or oral contraceptives).
- History of severe anaphylactic reaction with the administration of equine plasma.
- Patients with comorbidities that justify a risk of high mortality from causes independent of SARS-CoV-2 infection (eg, stage IV cancer)
- Patient who does not consent to participate.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04913779
Start Date
June 1 2021
End Date
December 31 2021
Last Update
September 17 2021
Active Locations (1)
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1
Hospital General de Agudos Donación Francisco J. Santojanni
Buenos Aires, Argentina, 1408