Convalescent Plasma of Covid-19 to Treat SARS-COV-2 a Randomized Doble Blind 2 Center Trial

NCT04405310 | Completed Phase 2 DMC

• 1 other identifier: DI/20/201/04/19
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

SARS Pneumonia

Keywords

SARS-COV-2, CONVALESCENT PLASMA

Outcome Measures

Primary Outcomes (1)

• Death

  any cause

  15 days

Secondary Outcomes (6)

• Lenth of stay ICU

  15 days

• Days of Mechanical Ventilation

  15 days

• Suplemental Oxigen support

  15 days

• Viral Load by RT-PCR

  15 days

• Inflamatory biomarkers

  15 days

Study Arms (4)

EXP-PC-F2

EXPERIMENTAL

Patients with Pneumonia due to SARS-COV-2 phase 2 with Hyperimmune Plasma from Convalescent patients and conventional Therapy (Azithromycin and Hydroxychloroquine)

Biological: Convalescent Plasma of patients with COVID-19

EXP-NONPC-F2

PLACEBO COMPARATOR

20 Patients with Pneumonia due to SARS-COV-2 phase 2 with conventional Therapy (Azithromycin and Hydroxychloroquine) and 20% Albumin in Hartman Solution.

Other: placebo (hartmann plus albumine)

EXP-PC-F3

EXPERIMENTAL

20 Patients with Pneumonia due to SARS-VOC-2 phase 3 with Hyperimmune Plasma from Convalescent patients and conventional Therapy (Azithromycin and Hydroxychloroquine)

Biological: Convalescent Plasma of patients with COVID-19

EXP-NONPC-F3

PLACEBO COMPARATOR

20 Patients with Pneumonia due to SARS-VOC-2 phase 3 with conventional Therapy (Azithromycin and Hydroxychloroquine) and 20% Albumin in Hartman Solution.

Other: placebo (hartmann plus albumine)

Interventions

Convalescent Plasma of patients with COVID-19 BIOLOGICAL

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.

Also known as: Hyperinmunne plasma

EXP-PC-F2; EXP-PC-F3

placebo (hartmann plus albumine) OTHER

use of albumin 20% in 250cc of Hartmann solution

EXP-NONPC-F2; EXP-NONPC-F3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 to 70 years of age.
• Serious or critically ill patients confirmed for SARS-CoV-2 disease (RT-PCR).
• Meet the criteria for Disease with SARS-CoV-2 disease, phase II (Moderate) and phase III (severe) .
• Suspected Cytokine Release Syndrome with Hscore 169 points.
• Presence of severe acute hypoxemia with SpO2 \<90% in ambient air and / or PaO2 / FiO2 \<300 mmHg.
• Meet criteria (plain chest tomography or plain chest radiograph) for SARS-CoV-2 disease.
• Supplemental oxygen requirement either through the facial store plus reservoir bag, high-flow nasal tips or advanced airway management and invasive mechanical ventilation support.

You may not qualify if:

• patient has no interest in participating in the trial.
• Bilateral pulmonary infiltrate related to heart failure or other cause of water overload.
• Virus positive respiratory viral panel other than COVID-19
• History of allergy to plasma, sodium citrate, or methylene blue.
• Patients with a history of autoimmune diseases or selective IgA insufficiency.
• Those patients who are participating in other protocols.

Sponsors & Collaborators

• Grupo Mexicano para el Estudio de la Medicina Intensiva: lead
• Hospital General Naval de Alta Especialidad - Escuela Medico Naval: collaborator
• National Institute of Pediatrics, Mexico: collaborator
• Instituto Nacional de Enfermedades Respiratorias: collaborator

Study Sites (2)

Hospital Nava de Alta Especialidad

Mexico City, 04470, Mexico

Location

Hospital General de Mexico Dr Eduardo Liceaga

Mexico City, 06720, Mexico

Location

Related Publications (5)

• Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.

  PMID: 32113510 BACKGROUND

• Lu H. Drug treatment options for the 2019-new coronavirus (2019-nCoV). Biosci Trends. 2020 Mar 16;14(1):69-71. doi: 10.5582/bst.2020.01020. Epub 2020 Jan 28.

  PMID: 31996494 BACKGROUND

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

• van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.

  PMID: 26735992 BACKGROUND

• Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.

  PMID: 21248066 BACKGROUND

Study Officials

• ORLANDO CARILLO-TORRES, PHD

  Hospital General de Mexico Dr. Eduardo Liceaga

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: parallel design 3:2:3
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of division of critical care

Model Details: Parallel assignment, relationship 3.2.3

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 28, 2020
• Study Start: May 20, 2020
• Primary Completion: November 20, 2020
• Study Completion: December 10, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months after completion up to five years
• Access Criteria: proposal should be directed to gmemiinv@gmails.com, to gain access, requestor will need to sign a data access agreement

Locations

ME (2)