Status:
COMPLETED
Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) for Adult Patients With Mild COVID-19
Lead Sponsor:
TecSalud Investigación Clínica
Collaborating Sponsors:
Inosan Biopharma
Conditions:
COVID-19
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a randomized, placebo-controlled, double-blind phase I clinical study of anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) to evaluate the safety and antiviral efficacy for the...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
December 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04514302
Start Date
December 7 2021
End Date
August 1 2022
Last Update
January 26 2023
Active Locations (1)
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1
Hospital San José, Tec de Monterrey
Monterrey, Nuevo León, Mexico, 64718