Convalescent Plasma of Covid-19 to Treat SARS-COV-2 a Randomized Doble Blind 2 Center Trial

Currently, SARS-CoV-2 disease represents a Public Health emergency of international concern. The new coronavirus COVID-19 is estimated to have infected more than 1.8 million people worldwide. The WHO estimates that the contagion rate (R0) of the virus is 1.4 to 2.5, which affects its exponential replication. In the absence of an effective treatment for SARS-CoV-2 disease, there is an urgent need to evaluate therapeutic alternatives that reduce the mortality and morbidity of this virus. There is scientific evidence that supports the use of convalescent donor plasma for the treatment of emerging virus outbreaks and suggests that the transfusion of convalescent donor plasma is effective, and therefore the following question is established:

The use of plasma from convalescent donors by COVID-19 in patients with SARS-CoV-2 disease, stage II (moderate) and III (severe), is a treatment that reduces mortality?

Given that the mortality rate is a very relevant fact, which concerns the general population, the clinical treatments that can be used to reduce the mortality rate of critical cases are of great relevance. There are patients recovered from COVID-19 who are potential plasma donors, and in turn, many critical patients who need to receive it.

Currently, there are no effective treatments to address COVID-19 disease. A recent WHO report indicates that early results with the use of convalescent plasma suggest that it may be a potentially useful treatment modality for severe SARS-CoV-2 disease. The use of convalescent plasma from COVID-19 in acute infected patients is currently considered an experimental therapy. This implies the need to promote clinical trials in order to demonstrate their efficacy. It is recommended that the entire process from donor selection, processing, labeling, storage and distribution to be carried out in a specifically licensed institution. These institutions must have all the guarantees that prove the correct practice of the procedures.

The use of convalescent plasma has been used as rescue therapy in patients with SARS whose condition continues to deteriorate despite treatment with methylprednisolone pulses, in addition, different studies have shown a decrease in hospital stay, and lower mortality in patients treated with convalescent plasma compared to those in which this treatment was not used.

A multicenter randomized study by Hung showed that the use of convalescent plasma in patients with type A H1N1 influenza was associated with a lower viral load and a reduction in mortality 5 days after the onset of symptoms. A Mair-Jenkins meta-analysis showed that mortality was reduced after several doses of convalescent plasma, and another meta-analysis by Luke identified in 1703 patients with influenza pneumonia (1918-1925) that the use of convalescent plasma blood products an absolute reduction. 21% (95% CI 15-27; p = 0.001) in crude fatality with low risk of bias.

Inclusion criteria

• Adults 18 to 70 years of age.
• Serious or critically ill patients confirmed for SARS-CoV-2 disease (RT-PCR).
• Meet the criteria for Disease with SARS-CoV-2 disease, phase II (Moderate) and phase III (severe) .
• Suspected Cytokine Release Syndrome with Hscore 169 points.
• Presence of severe acute hypoxemia with SpO2 <90% in ambient air and / or PaO2 / FiO2 <300 mmHg.
• Meet criteria (plain chest tomography or plain chest radiograph) for SARS-CoV-2 disease.
• Supplemental oxygen requirement either through the facial store plus reservoir bag, high-flow nasal tips or advanced airway management and invasive mechanical ventilation support.

Exclusion criteria

• patient has no interest in participating in the trial.
• Bilateral pulmonary infiltrate related to heart failure or other cause of water overload.
• Virus positive respiratory viral panel other than COVID-19
• History of allergy to plasma, sodium citrate, or methylene blue.
• Patients with a history of autoimmune diseases or selective IgA insufficiency.
• Those patients who are participating in other protocols.