Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody Fragments (INOSARS) for Hospitalized Patients With COVID-19
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ClinicalTrials.gov Identifier: NCT04514302 |
Recruitment Status :
Not yet recruiting
First Posted : August 14, 2020
Last Update Posted : August 14, 2020
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: Placebo Drug: Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS) | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double Blind |
Primary Purpose: | Treatment |
Official Title: | Pilot Study to Evaluate Safety and Efficacy of Anti-SARS-CoV-2 Equine Immunoglobulin F(ab')2 Fragments (INOSARS) in Hospitalized Patients With COVID-19 |
Estimated Study Start Date : | October 20, 2020 |
Estimated Primary Completion Date : | February 20, 2021 |
Estimated Study Completion Date : | June 20, 2021 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Single dose of 150 mL of saline solution administered intravenously as an infusion at 4.0 mL/min over 40 min. n = 18.
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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 |
Experimental: INOSARS dose 1
Single dose of 2 vials of INOSARS in 150 mL of saline solution administered intravenously as an infusion at 4.0 mL/min over 40 min. n = 16
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Drug: Anti-SARS-CoV-2 equine immunoglobulin 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 |
Experimental: INOSARS dose 2
Description: Single dose of 6 vials of INOSARS in 150 mL of saline solution administered intravenously as an infusion at 4.0 mL/min over 40 min. n = 17
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Drug: Anti-SARS-CoV-2 equine immunoglobulin 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 |
- Proportion of patients with improvement in clinical status [ Time Frame: 28 days ]The primary endpoint is the proportion of patients with clinical improvement at 28 days after treatment. Clinical improvement is defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale. Scale categories as follows: 1 = not hospitalized; 2 = not hospitalized with limitation of activities and/or oxygen requirement; 3 = hospitalized not requiring supplemental oxygen and not requiring active medical care, 4 = hospitalized requiring active medical care without requiring oxygen supplementation; 5 = hospitalized requiring oxygen supplementation; 6 = hospitalized requiring high-flow oxygen or non-invasive mechanical ventilation; 7 = hospitalized requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8 = death.
- Time to clinical improvement [ Time Frame: 28 days ]Time from the day of treatment until the first day with clinical improvement, defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale.
- Proportion of patients that reach a score of 6, 7 or 8 in the NIAID 8-point ordinal scale [ Time Frame: 28 days ]Proportion of participant death or non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation requirement.
- Duration of hospitalization [ Time Frame: 28 days ]Measured in days
- SARS-CoV-2 PCR negativization rate [ Time Frame: 3 days ]Proportion of patients that have a negative polymerase chain reaction assay for SARS-CoV-2 at 72 hrs from start of treatment.
- Proportion of patients with clinical improvement at day 7 [ Time Frame: 7 days ]Proportion of patients with clinical improvement at day 7. Clinical improvement is defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale
- Proportion of patients with immediate adverse events (< 24 hours) [ Time Frame: 24 hours ]Proportion of patients that present within 24 hours of treatment with immediate adverse events defined as: skin rash and/or respiratory findings (dyspnea, wheezing, bronchospasm, hypoxia) and/or circulatory compromise (reduction of blood pressure or associated symptoms, i.e. syncope).
- Proportion of patients with late adverse events (1 - 28 days) [ Time Frame: 28 days ]Proportion of patients that present events associated with serum sickness (type 3 hypersensitivity), vasculitis, glomerulonephritis, arthritis.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects of both sexes aged ≥ 18 years
- Patients with a confirmed infection with SARS-CoV-2 by PCR
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Patients admitted for hospitalization for COVID-19 disease that fulfills any of the following:
- Clinical or imaging evidence of pneumonia defined as: SpO2 < 94% or PaO2/FiO2 (SpO2/FiO2) < 300 or chest imaging consistent with pneumonia or clinical evidence of pneumonia (fever, cough, dyspnea and respiratory frequency > 24 respirations/min) OR
- Score of 4 (hospitalized no oxygen requirement, requires medical care), 5 (hospitalized, low-flow oxygen requirement) or 6 (hospitalized, high-flow oxygen or non-invasive mechanical ventilation requirement) in the NIAID 8-point ordinal scale of clinical status for COVID-19
- High risk markers of disease progression (at least on serum inflammatory marker elevated: C reactive protein, D-dimer, lactate dehydrogenase, ferritin)
- Agrees to participate in the study and signs written informed consent (signed by relative if applicable)
Exclusion Criteria:• Patients with known equine allergies
- Patients with past medical history of serum sickness
- Patients with more than 4 days of hospitalization before being randomized in study
- Patients who have received convalescent plasma or intravenous immunoglobulin (IVIG) for COVID-19
- Pregnant or breastfeeding women
- Patients with chronic kidney disease under dialysis
- Patients under invasive mechanical ventilation and/or extracorporeal membrane oxygenation at the beginning of study
- Patients participating in another intervention clinical trial
- Patients who are immunocompromised or with another chronic condition, that is judged by medical staff, to be at higher risk of infection or complications from participating in study
- Patients who are judged by medical staff who are unlikely to survive at 48 hours

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514302
Contact: Servando Cardona-Huerta, MD, Ph. D. | +5218112121946 | servandocardona@tec.mx | |
Contact: Alejandro Torres-Quintanilla, MD, MSc | +528180205853 | atorresq@tec.mx |
Mexico | |
Hospital San José | |
Monterrey, Nuevo Leon, Mexico, 64718 |
Principal Investigator: | José F Castilleja-Leal, MD | Wellness and Prevention Center |
Responsible Party: | José Fernando Castilleja-Leal, Wellness and Prevention Director, Hospital San Jose Tec de Monterrey |
ClinicalTrials.gov Identifier: | NCT04514302 |
Other Study ID Numbers: |
INOSARS-CoV-2 TecSalud |
First Posted: | August 14, 2020 Key Record Dates |
Last Update Posted: | August 14, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 SARS-CoV-2 Immunoglobulin fragments |
Immunoglobulins Immunoglobulins, Intravenous Antibodies |
Immunoglobulin Fragments Immunologic Factors Physiological Effects of Drugs |