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Trial - NCT04514302


Column Value
Trial registration number NCT04514302
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04514302

First author
Last imported at : Aug. 4, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Aug. 4, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-08-14

Recruitment status
Last imported at : Aug. 4, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

key inclusion criteria - outpatient with a rt-qpcr confirmation of sars-cov-2 infection - body mass index (bmi) at screening of 18.0 - 34.9 kg/m^2 - presence of at least one symptom consistent with covid-19 - mild illness as defined by no requirement of supplementary oxygen or hospitalization criteria are met key exclusion criteria - presence of a risk factor for disease progression documented for covid-19 such as: uncontrolled diabetes, uncontrolled hypertension, cardiovascular disease, pulmonary disease, copd, asthma, active cancer, immunosuppression, hypercoagulable states, ckd currently under dialysis - documented allergy to equine serum proteins - previous hospitalization due to covid-19 - supplementary oxygen, invasive ventilation, or mechanical circulatory support requirements - having received convalescent plasma or intravenous immunoglobulins for the treatment of covid-19 - previous vaccination or plans to get vaccinated for covid-19 - in the opinion of investigator, other health conditions that suppose an increased risk of progression of disease note: other inclusion/exclusion criteria apply

Exclusion criteria
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

None

Number of arms
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Hospital San Jose Tec de Monterrey

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

55

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mexico

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Aug. 4, 2022, 4:30 p.m.
Source : ClinicalTrials.gov

32

primary outcome
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

Average change from baseline in viral load as quantified by RT-qPCR from nasopharyngeal swab samples;Proportion of patients with undetectable viral load as quantified by RT-qPCR from nasopharyngeal swab samples;Time of viral activity

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : Sept. 18, 2021, 5 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "5 mg/kg;1;infusion", "treatment_id": 95, "treatment_name": "Anti-sars-cov-2 equine immunoglobulin fragments", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "15 mg/kg;1;infusion", "treatment_id": 96, "treatment_name": "Anti-sars-cov-2 equine immunoglobulin fragments (inosars)", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "30 mg/kg;1;infusion", "treatment_id": 96, "treatment_name": "Anti-sars-cov-2 equine immunoglobulin fragments (inosars)", "treatment_type": "Immunoglobulins sars-cov-2 specific", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]