Efficacy and Safety of Three Different Doses of an Anti SARS-CoV-2 Hyperimmune Equine Serum in COVID-19 Patients (SECR-02)
Covid19
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Covid19, Anti-SARS-CoV-2 hyperimmune equine serum, Neutralizing antibodies, Passive Immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Subjects male or female, aged 18 and over.
- Acceptance to participate in the study by the signature of the informed consent by the subject or relative (if applicable).
- SARS-CoV-2 infection confirmed by reverse transcriptase -polymerase chain reaction (RT-PCR).
- SARS-CoV-2 pneumonia confirmed by chest X-ray.
- Patients with moderate or severe disease clinical presentation of the disease that require hospitalization.
- Being within 10 days of the initial COVID-19 related symptoms onset.
- Admission in the participating center within a 24hour period.
- Female patients of child-bearing age with a negative pregnancy test.
Exclusion Criteria:
- COVID-19 patients that do not require hospitalization (outpatient setting).
- Patients who are participating in other therapeutic clinical trials.
- COVID-19 patients who have received convalescent plasma treatment.
- Critical disease COVID- 19 patients (respiratory failure, septic shock, and/or multiple organ dysfunction, admission PaO2/FIO2 ratio < 100).
- Previously snake bitten individuals that received any type of equine hyperimmune serum treatment.
- History of an allergic reaction due to contact or exposure to horses.
- Pregnant or breastfeeding women.
- Patients who, at the investigator´s discretion, are not likely to comply with study indications and procedures.
- Patients currently undergoing hemodialysis in a renal support program.
- Individuals who were previously classified by their treating physicians (prior to the COVID-19 diagnosis), of having an unfavorable prognosis with a short lifespan due to a concomitant disease other than the study disease.
Sites / Locations
- Centro Especializado de Atención COVID19 (CEACO)Recruiting
- Hospital Dr. Rafael Ángel Calderón GuardiaRecruiting
- Hospital MéxicoRecruiting
- Hospital San Juan de DiosRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Anti SARS-CoV-2 equine hyperimmune serum
Placebo
All participants in the treatment groups will receive a single intravenous infusion on day 1 containing the specified dose according to their assigned group 12mg/kg, 30 mg/kg or 56mg/kg. Total volume of the infusion is 180ml, to be administered during a time period of at least 1 hour. Study participants will be followed during their hospitalization until they are discharged and on Study Day 28.
All participants in the placebo group will receive a single intravenous infusion on day 1 containing a specified volume of a saline IV solution preparation. Total volume of the infusion is 180ml, to be administered during a time period of at least 1 hour. Study participants will be followed during their hospitalization until they are discharged and on Study Day 28.