Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) for Adult Patients With Mild COVID-19
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, Immunoglobulin fragments, Hyperimmune equine serum, Passive immunotherapy
Eligibility Criteria
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
Sites / Locations
- Hospital San José, Tec de Monterrey
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
Placebo
INOSARS dose 1
INOSARS dose 2
INOSARS dose 3
Single dose of a 150 mL saline solution administered intravenously as an infusion over 40 min.
Single dose of 5 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.
Single dose of 15 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.
Single dose of 30 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.