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Trial record 1 of 1 for:    NCT04479163
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Prevention of Severe Covid-19 in Infected Elderly by Early Administration of Convalescent Plasma With High-titers of Antibody Against SARS-CoV2

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ClinicalTrials.gov Identifier: NCT04479163
Recruitment Status : Completed
First Posted : July 21, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Fundacion Infant

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 <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.


Condition or disease Intervention/treatment Phase
COVID Biological: Convalescent Plasma Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Severe Covid-19 in Infected Elderly by Early Administration of Convalescent Plasma With High-titers of Antibody Against SARS-CoV2.
Actual Study Start Date : June 4, 2020
Actual Primary Completion Date : October 25, 2020
Actual Study Completion Date : October 25, 2020

Arm Intervention/treatment
Experimental: Plasma
Convalescent plasma with an IgG titer against SARS-CoV2
Biological: Convalescent Plasma
250 ml Convalescent plasma with an IgG titer against SARS CoV2

Placebo Comparator: Placebo
Normal Saline 0.9%
Other: Placebo
Normal Saline 0.9%




Primary Outcome Measures :
  1. Development of severe respiratory disease defined as a respiratory rate (RR)>30 and/or an O2 sat<93% [ Time Frame: From 12 hours post infusion to day 15 post infusion ]

Secondary Outcome Measures :
  1. Life threatening respiratory disease [ Time Frame: From 12 hours post infusion to day 25 post infusion ]
  2. Critical systemic illness, defined as respiratory failure [ Time Frame: From 12 hours post infusion to day 25 post infusion ]
  3. Death [ Time Frame: From 12 hours post infusion to day 25 post infusion ]
  4. Combination of secondary outcomes #2 (Life threatening respiratory disease) and/or #3 (Critical systemic illness, defined as respiratory failure) and//or #4 (death) [ Time Frame: From 12 hours post infusion to day 25 post infusion ]
  5. Duration of oxygen support requirement in patients with covid-19 due to saturation in ambient air <93%. [ Time Frame: From 12 hours post infusion to day 25 post infusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04479163


Locations
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Argentina
Hospital Militar Central
Caba, Buenos Aires, Argentina, 1426
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
Sponsors and Collaborators
Fundacion Infant
Investigators
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Study Director: Fernando P Polack, MD Fundacion Infant
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundacion Infant
ClinicalTrials.gov Identifier: NCT04479163    
Other Study ID Numbers: FundacionINFANT-Plasma
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No