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.
This is a two-center, randomized, placebo-controlled pilot study of anti-SARS-CoV-2 equine immunoglobulin fragments F(ab')2 (INOSARS) to evaluate safety and preliminary efficacy in the treatment of hospitalized COVID-19 patients. Subjects included in the study are hospitalized adult patients with a diagnosis of COVID-19, that: 1) require supplementary oxygen or non-invasive mechanical ventilation OR 2) have clinical or imaging evidence of pneumonia OR 3) have laboratory markers of risk of disease progression (high levels of serum inflammatory markers). The sample size is 51 patients randomized to one of three arms: 18 patients to placebo, 16 patients to dose 1 and 17 patients to dose 2 of anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments. The safety outcome is the proportion of patients with early and late adverse events until the end of follow-up at 28 days, for both doses of treatment. The primary outcome is the proportion of patients with clinical improvement at 28 days from the start of treatment, comparing between both treatment groups vs placebo. Clinical improvement is defined as a reduction of 1 point in the NIAID 8-point ordinal scale of clinical status for COVID-19 patients or hospital discharge, whichever comes first.
Drug: Placebo
Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering.
Other Name: Control
Drug: Anti-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.
Other Name: INOSARS
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
Hospital San José, Tec de Monterrey
Monterrey, Nuevo Leon, Mexico
José F Castilleja-Leal, MD, Principal Investigator
Hospital San Jose Tec de Monterrey