Status:
COMPLETED
Prevention of Severe Covid-19 in Infected Elderly by Early Administration of Convalescent Plasma With High-titers of Antibody Against SARS-CoV2
Lead Sponsor:
Fundacion Infant
Conditions:
COVID
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Trial design. Randomized, double-blind, placebo-controlled trial in a catchment population of 2,020,860 age-appropriate subjects in the state of Buenos Aires and 235,000 in the city of Buenos Aires. ...
Eligibility Criteria
Inclusion
- \- Age ≥ 75 or age 65-74 with at least 1 of the following comorbidities: arterial hypertension, diabetes, obesity, chronic obstructive pulmonary disease, heart disease, chronic kidney disease
- Last 48 hours: (A)Axillary temperature ≥ 37.5oC or febrile equivalent, combined with (a) dry cough and/or (b) breathing difficulty and/or (c) odinophagia and/or (d) anosmia/dysgeusia and/or (e) any of the following symptoms: fatigue, anorexia, myalgias or rhinorrhea.
- Confirmed diagnosis SARS-Cov2 by RT-PCR
- Give Informed consent
Exclusion
- Severe respiratory disease
- Cardiac insufficiency,
- Chronic renal failure,
- Primary hypogammaglobulinemias,
- Myelodysplastic syndromes,
- Chronic linfoproliferative syndromes,
- Monoclonal gammapathies,
- Known hypersensitibility,
- Active cancer,
- HIV, HBV or HCV infection,
- Chronic administration of immunosuppressants,
- Body transplant history,
- Chronic liver disease, Chronic lung disease with oxygen requirement.
Key Trial Info
Start Date :
June 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2020
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04479163
Start Date
June 4 2020
End Date
October 25 2020
Last Update
December 22 2020
Active Locations (11)
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1
Hospital Militar Central
CABA, Buenos Aires, Argentina, 1426
2
CEMIC
CABA, Buenos Aires, Argentina
3
Centro de Investigacion Clinica OSECAC
CABA, Buenos Aires, Argentina
4
Centro Gallego de Buenos Aires
CABA, Buenos Aires, Argentina