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Trial - NCT04913779


Column Value
Trial registration number NCT04913779
Full text link
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04913779

First author
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Guillermo A Keller, MD PhD

Contact
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

gkeller@anlis.gob.ar

Registration date
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-06-04

Recruitment status
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: 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 criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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.

Number of arms
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Administracion Nacional de Laboratorios e Institutos de Salud Dr. Carlos G. Malbran

Inclusion age min
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Argentina

Type of patients
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

200

primary outcome
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Change in time needed to clinical improvement

Notes
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

Arms
Last imported at : June 8, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 474, "treatment_name": "Equine covid-19 antiserum [f(ab')2]", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]