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Trial - NCT04610502


Column Value
Trial registration number NCT04610502
Full text link
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04610502

First author
Last imported at : Nov. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Alfredo Sanabria, PhD

Contact
Last imported at : Nov. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

asccheo@yahoo.com

Registration date
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-10-30

Recruitment status
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - agreement to participate in the study by signing the prior informed consent. - age over 18 years. - inpatient with rt-pcr confirmation of sars-cov-2. - period of onset of symptoms related to covid-19 not greater than 10 days - presence of at least 2 documented risk factors - moderate and severe clinical presentation of the disease.

Exclusion criteria
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- patients who did not sign the informed consent. - critical patient. - patient previously bitten by a snake that was treated with equine hyperimmune serum. - patients with covid-19 on an outpatient basis. - pregnant women. - patients in hemodialysis program. - patients who have already received plasma from a convalescent covid-19 patient. - patients who were classified prior to the diagnosis of covid-19 by the treating physician as having a reserved prognosis with a short lifespan.

Number of arms
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Caja Costarricense de Seguro Social

Inclusion age min
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Costa Rica

Type of patients
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

26

primary outcome
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

To evaluate safety of two formulations of equine anti-SARS-CoV-2 immunoglobulins ("S" and "M").;To evaluate the efficacy and safety of two formulations of equine anti-SARS-CoV-2 immunoglobulins ("S" and "M").

Notes
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 98, "treatment_name": "Anti-sars-cov-2 equine immunoglobulin \"s\"", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 97, "treatment_name": "Anti-sars-cov-2 equine immunoglobulin \"m\"", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}]