Official Title
Prevention of Severe Covid-19 in Infected Elderly by Early Administration of Convalescent Plasma With High-titers of Antibody Against SARS-CoV2.
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. Institutions. Hospitals San Juan de Dios, Simplemente Evita, Dr. Carlos Bocalandro, Evita Pueblo, Sanatorio Antartida, Hospital Central de San Isidro, Clinica Olivos in the state of Buenos Aires with 38 regional and town hospitals acting as referral centers, and Hospital Militar Central, Sanatorio de Los Arcos, Hospital Universitario CEMIC, Sanatorio Sagrado Corazon, Sanatorio Finochietto, Sanatorio Anchorena, Centro Gallego, and in the city of Buenos Aires in Argentina. Study population. Subjects >= 75 years of age irrespective of presenting comorbidities or between 65-74 years of age with at least one comorbidity (hypertension, diabetes, obesity, chronic renal failure, and COPD) who experience the following signs and symptoms for less than 48 hours at the time of screening for SARS CoV2 by RT-PCR: (a) a temperature >=37.5°C and/or unexplained sweating and/or chills and (b) at least one of the following: dry cough, dyspnea, fatigue, myalgia, anorexia, sore throat, loss of taste and/or smell, rhinorrhea. Subjects consenting to screening will be tested by reverse-transcriptase-polymerase-chain-reaction (RT-PCR) for SARS-CoV-2 in a nasopharyngeal and an oropharyngeal swab and invited to participate when RNA for the virus is detected. Intervention. Eligible, consenting patients will be randomized using an electronic system to receive 250 ml of convalescent plasma with an IgG titer against SARS-CoV2 spike (S) protein >1:1,000 (COVIDAR IgG, Insituto Leloir, Argentina) or placebo (normal saline 0.9%) administered in a 1:1 ratio. Both treatment and placebo will be concealed using dark bags and tape to cover the infusion line. Treatment will be administered 30 and/or an O2 sat

Completed
COVID

Biological: Convalescent Plasma

250 ml Convalescent plasma with an IgG titer against SARS CoV2

Other: Placebo

Normal Saline 0.9%

Eligibility Criteria

Inclusion Criteria:

- 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 Criteria:

- 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.

Eligibility Gender
All
Eligibility Age
Minimum: 65 Years ~ Maximum: N/A
Countries
Argentina
Locations

Hospital Militar Central
Caba, Buenos Aires, Argentina

CEMIC
Caba, Buenos Aires, Argentina

Centro de Investigacion Clinica OSECAC
Caba, Buenos Aires, Argentina

Centro Gallego de Buenos Aires
Caba, Buenos Aires, Argentina

Sanatorio Anchorena
Caba, Buenos Aires, Argentina

Sanatorio de Los Arcos
Caba, Buenos Aires, Argentina

Hospital "Simplemente Evita"
González Catán, Buenos Aires, Argentina

Hospital Especializado de Agudos y Crónicos "San Juan de Dios"
La Plata, Buenos Aires, Argentina

Clinica Olivos
Buenos Aires, Argentina

Hospital Central de San Isidro
Buenos Aires, Argentina

Hospital General de Agudos "Dr. Carlos Bocalandro"
Buenos Aires, Argentina

Fernando P Polack, MD, Study Director
Fundacion Infant

Fundacion Infant
NCT Number