Prevention of Severe Covid-19 in Infected Elderly by Early Administration of Convalescent Plasma With High-titers of Antibody Against SARS-CoV2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-04

Study Completion Date

2020-10-25

Brief Summary

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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 \<72 hours from initiation of symptoms. Subjects will be monitored for 12 hours after treatment for adverse events.

Clinical and laboratory monitoring. All participating subjects will be admitted to the hospital upon enrollment. Twenty-four hours after completing the infusion, a sample of venous blood (5 ml) will be obtained from all participants to measure anti-S IgG SARS-CoV2 in serum (COVIDAR IgG, Leloir) and preserved at -20°C until completion of the study. Patient evolution will be assessed daily by study physicians during hospitalization until day 25 and/or at home until day 15, in the event of earlier discharge from the hospital. Study physicians will use predesigned questionnaires to collect clinical information. An Independent Data Safety Monitoring Board (DSMB) will supervise participating subjects during the study.

Endpoints. The primary endpoint of the trial is development of severe respiratory disease defined as a respiratory rate (RR)\>30 and/or an O2 sat\<93% when breathing room air determined using a predefined protocol. Three other clinical endpoints include (a) life threatening respiratory disease, defined as need for 100% oxygen supplementation and/or non-invasive or invasive ventilation and/or admission to intensive care; (b) critical systemic illness, defined as respiratory failure (PaO2/FiO2 ≤ 200 mm Hg) and/or shock and/or multiorganic distress syndrome; and (c) death.

Statistical analysis. The study is designed to have one interim analysis when the outcome results for 50% of the subjects is obtained. The minimally clinically important difference was set at a 40% relative reduction for an expected outcome rate of 50% in the control group reduced to 30% in the intervention group. A total sample size of 210 subjects (105 per trial arm) was estimated to have 80% power at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.

Ethical considerations. The trial has been approved by the institutional review boards of participating institutions and the Central Ethics Committee of the state of Buenos Aires. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonization. Written informed consent will be obtained from all patients for screening and enrollment.

Detailed Description

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Conditions

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COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Plasma

Convalescent plasma with an IgG titer against SARS-CoV2

Group Type EXPERIMENTAL

Convalescent Plasma

Intervention Type BIOLOGICAL

250 ml Convalescent plasma with an IgG titer against SARS CoV2

Placebo

Normal Saline 0.9%

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Normal Saline 0.9%

Interventions

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Convalescent Plasma

250 ml Convalescent plasma with an IgG titer against SARS CoV2

Intervention Type BIOLOGICAL

Placebo

Normal Saline 0.9%

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando P Polack, MD

Role: STUDY_DIRECTOR

Fundacion Infant

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Argentina

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FundacionINFANT-Plasma

Identifier Type: -

Identifier Source: org_study_id

Prevention of Severe Covid-19 in Infected Elderly by Early Administration of Convalescent Plasma With High-titers of Antibody Against SARS-CoV2

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Plasma

Convalescent Plasma

Placebo

Placebo

Interventions

Convalescent Plasma

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Fundacion Infant

Responsible Party

Principal Investigators

Fernando P Polack, MD

Locations

Hospital Militar Central

CEMIC

Centro de Investigacion Clinica OSECAC

Centro Gallego de Buenos Aires

Sanatorio Anchorena

Sanatorio de Los Arcos

Hospital "Simplemente Evita"

Hospital Especializado de Agudos y Crónicos "San Juan de Dios"

Clinica Olivos

Hospital Central de San Isidro

Hospital General de Agudos "Dr. Carlos Bocalandro"

Countries

References

Other Identifiers

FundacionINFANT-Plasma