Clinical trial NCT04395170: Convalescent Plasma (PC) and Human Intravenous Anti-COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.
Official title: A Randomized, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Use of Convalescent Plasma (PC) and Human Intravenous Anti COVID-19 Immunoglobulin (IV Anti COVID-19 IgG) in Patients Hospitalized for COVID-19.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Coronavirus Disease 2019 (COVID-19)
Keywords: coronavirus
Lead sponsor: Lifefactors Zona Franca, SAS
Sponsor class: INDUSTRY
First posted: 2020-05-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin) compared to the standard treatment in Colombia.

Detailed description: The study population will be patients (≥18 years) hospitalized by COVID-19 but still with an early form of the disease (in states 1-3 of the ordinal scale) who do not require mechanical ventilation (invasive or non-invasive) and who can give their consent informed.

All the participants will receive non-specific supportive treatment for COVID-19 such as oxygen, IV liquid or corticosteroids. Additionally, they will be randomized to one of the following arms:

Experimental arm 1: Plasma with inactivation/reduction of pathogens from convalescent patients with COVID-19 and who at the same time receive support therapy, in the 200 - 250 mL scheme, on days 1 and 3 of the intervention.

Experimental arm: Anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenous at a dose of immunoglobulin 10% IgG solution (10% mL vial) for:

Patient of 50 Kg or more, a dose of 50 mL will be applied on days 1 and 3 of treatment.

Patients of less than 50 Kg, the dose will be 1 mL / Kg, will be applied on days 1 and 3 of treatment.

This arm will be included once available. The supply of anti-COVID-19 human immunoglobulin produced by LifeFactors will be carried out once the national regulatory agency (Invima) grants authorization and/or the regulatory requirements for the production of medications are met.

Control arm: Standard (specific) therapy for COVID-19 according to the suggested pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are determined by the Colombian Health Regulatory Authorities.

Eligibility criteria: Inclusion Criteria:

1. Obtaining the informed written consent before carrying out the study procedures, by the patients.
2. Adult patients ≥18 years at the time of recruitment for the study.
3. Patients with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction on nasal/oropharyngeal swabs or any other relevant specimen \<72 hours before randomization.
4. Patients requiring hospitalization for COVID-19 without mechanical ventilation (invasive or non-invasive, including an oxygen mask with reserve bag) and at least one of the following:

   1. Radiographic evidence of pulmonary infiltrates by images (chest radiography, computed tomography, etc.),
   2. Clinical evaluation (evidence of rales/crackles on examination) and oxygen saturation ≤ 94% in ambient air requiring supplemental oxygen.
5. Patient with no more than 72 hours (3 days) of hospitalization prior to the administration of PC treatment (except the days after initial hospital admission for other reasons and prior to COVID-19 infection).
6. Patients who do not have more than 10 days between the onset of symptoms (fever or cough) and the day of administration of treatment or the demonstration of the absence of anti-SARS-CoV-2 antibodies (patients with more than 10 days of symptoms they can only be included if a negative antibody result has been confirmed).

Exclusion Criteria:

1. Patient in a state of pregnancy.
2. Require mechanical ventilation (invasive or non-invasive, including oxygen mask with reserve bag) on examination.
3. Participation in any other clinical trial of an experimental treatment for COVID-19.
4. At the discretion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, regardless of the provision of treatments.
5. Any incompatibility or allergy to the administration of plasma of human origin.
6. Severe chronic kidney disease in stage 4 or requiring dialysis (that is, glomerular filtration rate \<30).
7. Any condition that in the investigator's opinion limits participation in the study.

Primary outcomes:
measure: Admission to ICU and/or mechanical ventilation
timeFrame: One year
Secondary outcomes:
measure: Length of hospital stay
timeFrame: One year
measure: Neutralizing antibody (IgG) titers against COVID-19
timeFrame: One year
measure: Safety - Adverse events
timeFrame: One year
measure: Death
timeFrame: One year
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: LifeFactors Zona Franca SAS
state: Antioquia
Study officials:
References:
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