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

NCT04452812 | Unknown Phase 1

• 1 other identifier: HUS-001/2020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia; Convalescent Plasma

Keywords

COVID-19; Convalescent plasma; plasmapheresis

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  Any cause mortality during the first 30 days of treatment

  30 days

• Side effects

  Side effects associated with the administration of convalescent plasma

  30 days

Secondary Outcomes (7)

• Length of stay in Intensive Care Unit (ICU)

  14 days

• Length of stay in hospitalization

  21 days

• Days of mechanical ventilation

  14 days

• Inflammatory biomarkers (d-dimer)

  21 days

• Inflammatory biomarkers (c-reactive protein)

  21 days

Study Arms (2)

Convalescent plasma

EXPERIMENTAL

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.

Biological: Convalescent plasma

Best available treatment

PLACEBO COMPARATOR

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.

Biological: Convalescent plasma

Interventions

Convalescent plasma 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; Convalescent plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• At least positive for 1 q-PCR test for SARS-CoV-2
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad Autonoma de Coahuila: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Hospital Universitario "Dr. Gonzalo Valdés Valdés"

Saltillo, Coahuila, 25000, Mexico

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Julio César Martínez Gallegos, MD, MMSc

CONTACT

8113852249; juliomartinez.18@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, experimental, randomized, prospective, longitudinal, clinical study

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: June 30, 2020
• Study Start: July 6, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ME (1)