COVID-19
Conditions
Keywords
COVID-19, SARS-CoV-2, Immunoglobulin fragments, Hyperimmune equine serum, Passive immunotherapy
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 treatment of adult patients with mild COVID-19 and low risk of disease progression.
Interventions
DRUGPlacebo
Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering.
DRUGAnti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS)
INOSARS is a polyvalent passive immunization based on anti-SARS-CoV-2 immunoglobulin F(ab')2 fragments from hyperimmune equine serum. Inactive ingredients: water for injection, sodium chloride and less than 10% of total protein content.
Sponsors
Inosan Biopharma
TecSalud Investigación Clínica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind
Intervention model description
Parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average change from baseline in viral load as quantified by RT-qPCR from nasopharyngeal swab samples | Baseline to days 2, 4, 7, 14 and 28 | — |
| Proportion of patients with undetectable viral load as quantified by RT-qPCR from nasopharyngeal swab samples | At days 2, 4, 7, 14 and 28 | — |
| Time of viral activity | Baseline to 28 days | Number of days in which viral load remains detectable as quantified by RT-qPCR from nasopharyngeal swab samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events presented early after infusion | Baseline to 24 hrs | Number of adverse events per group presented in the first 24 hours |
| Adverse events presented later after infusion | Day 2 until day 28 | Number of adverse events per group presented 24 hours past infusion |
| Incidence of anti-INOSARS antibodies | Baseline and day 28 | — |
Countries
Mexico
Outcome results
None listed