Status:
UNKNOWN
Efficacy and Safety of Three Different Doses of an Anti SARS-CoV-2 Hyperimmune Equine Serum in COVID-19 Patients
Lead Sponsor:
Caja Costarricense de Seguro Social
Collaborating Sponsors:
Universidad de Costa Rica
Ministry of Health Costa Rica
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Passive immunotherapy is a therapeutic alternative used in a variety of infectious diseases including COVID-19. Equine polyclonal hyperimmune sera is a source of neutralizing antibodies against SARS-C...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2021
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04838821
Start Date
March 29 2021
End Date
September 29 2021
Last Update
May 21 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro Especializado de Atención COVID19 (CEACO)
San José, Costa Rica
2
Hospital Dr. Rafael Ángel Calderón Guardia
San José, Costa Rica
3
Hospital México
San José, Costa Rica
4
Hospital San Juan de Dios
San José, Costa Rica