Convalescent Plasma of Covid-19 to Treat SARS-COV-2 a Randomized Doble Blind 2 Center Trial
Condition: SARS Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 2

Summary: 
      The new SARS-CoV-2 coronavirus is an emerging virus originating in Wuhan, China that has
      spread rapidly throughout the world. As of March 24, 2020, China had reported 81,767 cases
      with 3,281 deaths, and the World Health Organization (WHO) declared coronavirus 19 (COVID-19)
      a pandemic. COVID-19 disease is currently a pandemic without specific therapeutic agents and
      substantial mortality. So it is of utmost importance to find new treatments. Various
      therapies, such as Remdesivir and Favipiravir, are being investigated but the antiviral
      efficacy of these drugs is not yet known. The use of convalescent plasma was used as an
      empirical treatment during the Ebola virus outbreaks in 2014 and in 2015 a protocol was
      established for the treatment of the Middle East respiratory syndrome coronavirus (MERS) with
      convalescent plasma. This approach with other viral infections such as SARS-CoV, H5N1 avian
      influenza and H1N1 influenza suggesting that plasma transfusion from convalescent donors was
      effective.

      For this study, plasma from convalescent donors will be collected from those donors who have
      recovered from SARS-CoV-2 and are between 10 and 14 days after illness. Immunoassays will be
      carried out to detect total IgM and IgG antibodies against SARS-CoV-2. Patients will receive
      1 to 3 convalescent plasma transfusions, depending on the response to treatment.

      The expected results are: normal body temperature, decrease in viral load or negative between
      10-12 days after transfusion of convalescent plasma, which does not progress to ARDS,
      extubation of mechanical ventilation within two weeks of treatment, recovery of patient.
    

Detailed description: 
      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.
    

Intervention name(s): Convalescent Plasma of patients with COVID-19; placebo (hartmann plus albumine)
Intervention type(s): Biological; Other
Intervention description(s): Convalescent Plasma from patients with covid-19 by Apheresis, the maximum plasma volume withdrawn per session should not exceed 600 mL, excluding the anticoagulant volume, or 16% of the total blood volume, in the absence of volumetric replacement.; use of albumin 20% in 250cc of Hartmann solution
Other intervention name(s): Hyperinmunne plasma
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment, relationship 3.2.3
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: SARS-COV-2, CONVALESCENT PLASMA