Statistical and Epidemiological Study Based on the Use of Convalescent Plasma for the Management of Patients With COVID-19

Overview

The health contingency established against the Severe Acute Respiratory Syndrome associated type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on treatment against the disease related with coronavirus (COVID-19). There are no current approved therapeutic options against the virus, although there is a rush for the development of drugs, vaccines and even the passive immunization through plasma from convalescent patients. This passive immunization is made with the administration of antibodies from patients that went through the infectious state of the disease and progress to clinical remission.

SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma to patients with the infection brings the probability on eliminating the infection, in this case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused by SARS-CoV-1, Influenza AH1N1 and Ebola virus.

The objective of the study is to develop a therapeutic strategy based on the administration of plasma from patients with COVID-19 with clinical remission to patients that are coursing with the infection. The expected results hopes to establish an effective treatment and satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective antibodies related against the SARS-CoV-2 infection.

Full Title of Study: “Pilot Clinical, Statistical and Epidemiological Study on Efficacy and Safety of Convalescent Plasma for the Management of Patients With COVID-19″

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: March 1, 2021

Detailed Description

The health contingency established against the Severe Acute Respiratory Syndrome associated type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on treatment against the disease related with coronavirus (COVID-19). There are no current approved therapeutic options against the virus, although there is a rush for the development of drugs, vaccines and even the passive immunization through plasma from convalescent patients. This passive immunization is made with the administration of antibodies from patients that went through the infectious state of the disease and progress to clinical remission.

SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma to patients with the infection brings the probability on eliminating the infection, in this case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused by SARS-CoV-1, Influenza AH1N1 and Ebola virus.

The objective of the study is to develop a therapeutic strategy based on the administration of plasma from patients with COVID-19 with clinical remission to patients that are coursing with the infection. The expected results hopes to establish an effective treatment and satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective antibodies related against the SARS-CoV-2 infection.

Interventions

  • Biological: Convalescent plasma
    • Best available treatment + convalescent plasma Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician. Plasma will be split by aliquots of 200 ml for its storage on -60 celsius degrees until it’s used. After defrosting, it will be administered on 2 200 ml separated doses on a 12 hours interval.

Arms, Groups and Cohorts

  • Experimental: Convalescent plasma
    • Best available treatment + convalescent plasma Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician. Plasma will be split by aliquots of 200 ml for its storage on -60 celsius degrees until it’s used. After defrosting, it will be administered on 2 200 ml separated doses on a 12 hours interval.
  • Placebo Comparator: Best available treatment
    • Best available treatment + Placebo (0.9% saline solution) Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician. Placebo will consist on 2 doses of 200 ml of 0.9% saline solution separated on a 12 hour interval.

Clinical Trial Outcome Measures

Primary Measures

  • All-cause mortality
    • Time Frame: 30 days
    • Any cause mortality during the first 30 days of treatment
  • Side effects
    • Time Frame: 30 days
    • Side effects associated with the administration of convalescent plasma

Secondary Measures

  • Length of stay in Intensive Care Unit (ICU)
    • Time Frame: 14 days
    • Time to discharge from the ICU
  • Length of stay in hospitalization
    • Time Frame: 21 days
    • Time for discharge from hospital
  • Days of mechanical ventilation
    • Time Frame: 14 days
    • Number of days with ventilatory support
  • Inflammatory biomarkers
    • Time Frame: 21 days
    • change in pro-inflammatory biomarkers (D dimer, ferritin, PCR and LDH)

Participating in This Clinical Trial

Inclusion Criteria (Donors):

  • Signed informed consent
  • At least positive for 1 q-PCR test for SARS-CoV-2
  • 14 days of COVID-19 clinical remission
  • Positive serologic test for SARS-CoV-2
  • Requirements to donate according to NOM-253-SSA1-2012
  • To accept sample storing for future study

Inclusion Criteria (Receptors):

  • Signed informed consent provided by the patient, legal guardian or the health provider if not available
  • Patients hospitalized in an ICU dedicated to the treatment of COVID-19 patients
  • At least positive for 1 q-PCR test for SARS-CoV-2
  • Patients with COVID-19 defined as severe or critically ill:

Severe: RF > 30 bpm, oxygen saturation <94%, Pa/FiO2 <301, bilateral lung infiltrates that extends in >50% (by chest radiograph or CT scan) in 24-48 hours Critically ill: Respiratory failure (PaO2 <60 mmHg or SatO2 <90% with FiO2 >60%) and septic shock (MAP <65 mmHg with vasoactive requirement, lactate > 2 mmol/L and SOFA score >1)

Exclusion Criteria

  • Positive pregnancy test
  • Patients in lactation
  • Informed consent not signed
  • Patients involved in other treatment protocols
  • Patients on immunomodulatory drugs (DMARDs, monoclonal antibodies or smal molecule drugs)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad Autonoma de Coahuila
  • Collaborator
    • National Council of Science and Technology, Mexico
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Julio César Martínez Gallegos, MD, MMSc, 8113852249, juliomartinez.18@hotmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.