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

NCT ID: NCT04452812

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-06
• Study Completion Date: 2021-04-01

Brief Summary

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.

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.

Conditions

COVID-19 Pneumonia; Convalescent Plasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Convalescent plasma

Intervention Type: BIOLOGICAL

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.

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.

Group Type: PLACEBO_COMPARATOR

Convalescent plasma

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

Universidad Autonoma de Coahuila

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario "Dr. Gonzalo Valdés Valdés"

Saltillo, Coahuila, Mexico

Countries

Mexico

Central Contacts

Julio César Martínez Gallegos, MD, MMSc

Role: CONTACT

juliomartinez.18@hotmail.com

8113852249

Facility Contacts

Julio César Martínez Gallegos, MD, MSc

Role: primary

juliomartinez.18@hotmail.com

8113852249

Other Identifiers

HUS-001/2020

Identifier Type: -

Identifier Source: org_study_id