Status:
COMPLETED
A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19.
Lead Sponsor:
Inmunova S.A.
Conditions:
Covid19
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
PHASE3
Brief Summary
This study aims to analyze the efficacy and safety of passive immunotherapy by administering an equine hyperimmune serum (INM005) against the SARS-CoV2 RBD to Covid19 patients. Improvement of the clin...
Detailed Description
The pandemic caused by the new coronavirus has generated a situation unprecedented in recent history, with several million infected and hundreds of thousands of deaths. This disease is easily transmis...
Eligibility Criteria
Inclusion
- Subjects of both sexes aged 18 to 79 years of age
- SARS-CoV-2 infection confirmed by PCR for virus detection
- Patients with moderate or severe disease by NIH definition, which requires hospitalization.
- Acceptance to participate in the study by the signature of the informed consent by a subject or their relative, if applicable
- Be within 10 days of the onset of symptoms at the time of the Screening visit according to a case definition from the National Ministry of Health
- Female patients of child-bearing age with negative pregnancy test
Exclusion
- Patients who have received treatment with plasma from COVID-19 convalescents.
- Patients who are participating in other therapeutic clinical trials
- Patients who require mechanical respiratory assistance or are hospitalized in the ICU at the time of the screening visit.
- History of anaphylaxis, prior administration of equine serum (por example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) or allergic reaction due to contact or exposure to horses.
- Pregnant or breastfeeding women
- Patients who, at the doctor's discretion, are likely to die within the next 30 days due to a concomitant disease other than the study disease
- Patients who are expected to be referred to another institution within 72 hours of enrollment, which prevents proper follow-up of that patient.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT04494984
Start Date
July 27 2020
End Date
December 30 2020
Last Update
February 11 2021
Active Locations (23)
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1
Hospital de Cuenca Alta
Cañuelas, Buenos Aires, Argentina, B1814
2
Hospital Prof. Dr. Bernardo A. Houssay
Florida, Buenos Aires, Argentina
3
Instituto Medico Platense
La Plata, Buenos Aires, Argentina, B1900AVG
4
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina