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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04452812
Other study ID # HUS-001/2020
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 6, 2020
Est. completion date April 1, 2021

Study information

Verified date June 2020
Source Universidad Autonoma de Coahuila
Contact Julio César Martínez Gallegos, MD, MMSc
Phone 8113852249
Email juliomartinez.18@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date April 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Mexico Hospital Universitario "Dr. Gonzalo Valdés Valdés" Saltillo Coahuila

Sponsors (2)

Lead Sponsor Collaborator
Universidad Autonoma de Coahuila National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality Any cause mortality during the first 30 days of treatment 30 days
Primary Side effects Side effects associated with the administration of convalescent plasma 30 days
Secondary Length of stay in Intensive Care Unit (ICU) Time to discharge from the ICU 14 days
Secondary Length of stay in hospitalization Time for discharge from hospital 21 days
Secondary Days of mechanical ventilation Number of days with ventilatory support 14 days
Secondary Inflammatory biomarkers (d-dimer) change in D-dimer (micrograms/L) 21 days
Secondary Inflammatory biomarkers (c-reactive protein) change in C-reactive protein (milligrams/dL) 21 days
Secondary Inflammatory biomarkers (lactate dehydrogenase) Change in LDH (UI/L) 21 days
Secondary Inflammatory biomarkers (ferritin) Change in ferritin (nanograms/mL) 21 days
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