COVID-19 Pneumonia Clinical Trial
Official title:
Efficacy and Safety of Convalescent Plasma vs Human Immunoglobulin for the Treatment of COVID-19 Pneumonia: A Randomized Controlled Trial
Verified date | May 2020 |
Source | Centenario Hospital Miguel Hidalgo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: On December 2019, a new human coronavirus infection (COVID-19) was detected in China. Its infectivity and virulence characteristics caused a rapid spread, being declared pandemic on March 2020. The mortality attributed to the infection ranges between 3 and 10%. Main risk factors are age, male sex, and chronic degenerative comorbidities. Due to the absence of therapeutic options, potential alternatives such as human immunoglobulin or plasma from convalescent patients have been administered. Due to the severity of the disease and the associated mortality, it is urgent to find therapeutic alternatives. Objective: To assess the safety and efficacy of the administration of Convalescent plasma vs human immunoglobulin in critically ill patients with COVID-19 infection. Material and methods: Randomized Controlled trial of patients diagnosed with respiratory infection by COVID-19, with severe respiratory failure without indication of mechanical ventilation, or those who due to their severity are intubated upon admission. Randomization will be performed 2:1 to receive plasma from convalescent patients or human immunoglobulin. Outcomes: The primary outcome will be time to discharge from hospital for improvement. The safety outcomes will be: Kirby index (PaO2/FiO2) evolution and dead.
Status | Completed |
Enrollment | 196 |
Est. completion date | November 26, 2020 |
Est. primary completion date | November 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients who are admitted to Hospital Centers with a positive RT-qPCR SARS-CoV-2 test or a CT scan compatible with a diagnosis of COVID-19 pneumonia, in addition to one of the following two criteria: 1. Severe respiratory failure [respiratory rate> 25 - <35 x minute, oxygen saturation = 90% with reservoir mask (FiO2 = 100%)] 2. Requiring invasive mechanical ventilation. Exclusion Criteria: - Patients with a viral infection other than COVID-19 |
Country | Name | City | State |
---|---|---|---|
Mexico | Centenario Hospital Miguel Hidalgo | Aguascalientes |
Lead Sponsor | Collaborator |
---|---|
Centenario Hospital Miguel Hidalgo |
Mexico,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean hospitalization time | Mean days from admission as a suspected case of COVID with hospitalization criteria until discharge | Through study completion, an average of 3 months | |
Primary | Mean Oxigenation index evolution | Mean of delta of oxigenation index (PaO2/FiO2) | Through study completion, an average of 3 months | |
Primary | Rate of severe ARDS | Rate of patients with evolution to severe ARDS (PaO2/FiO2 < 100) | Through study completion, an average of 3 months | |
Primary | Rate and time to dead | Rate of Dead caused by COVID-19 related complications and time to dead caused by COVID-19 complication | Through study completion, an average of 3 months | |
Primary | Mean time with invasive mechanical ventilation | Mean time with invasive mechanical ventilation | Through study completion, an average of 3 months | |
Secondary | Time to Viral PCR Negativization | Time to negativization of RT-qPCR SARS-CoV-2 test. | Through study completion, an average of 3 months. |
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