Coronavirus Disease 2019 (COVID-19) Clinical Trial
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.
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.
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.
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