Convalescent Plasma Compared to the Best Available Therapy for the Treatment of SARS-CoV-2 Pneumonia

NCT04358783 | Completed Phase 2 DMC

• 1 other identifier: IF20-00002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

In early December 2019, cases of pneumonia of unknown origin were identified in Wuhan, China. The causative virus was called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) has recently declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern. According to the World Health Organization (WHO), the management of COVID-19 has focused primarily on infection prevention, detection and patient monitoring. However, there is no vaccine or specific treatment for SARS-CoV-2 due to the lack of evidence. Treatment options currently include broad-spectrum antiviral drugs but the efficacy and safety of these drugs is still unknown. Convalescent plasma has previously been used to treat various outbreaks of other respiratory infections; however, it has not been shown to be effective in all the diseases studied. Therefore, clinical trials are required to demonstrate its safety and efficacy in patients with VIDOC-19. The present work seeks to determine the mortality from any cause up to 14 days after plasma randomization of patients cured of COVID-19 compared to the Best Available Therapy in subjects with SARS-CoV-2 pneumonia. This is a 2:1 randomized, double-blind, single-center, phase 2, controlled clinical trial (plasma: best available therapy) for the treatment of SARS-CoV-2 pneumonia.

Conditions

Coronavirus Infection

Keywords

COVID-19; Plasma from patients cured; SARS-CoV-2 pneumonia

Outcome Measures

Primary Outcomes (1)

• Early all-cause mortality

  any cause mortality during the first 14 days of treatment

  14 days

Secondary Outcomes (3)

• Time in days for SARS-CoV-2 RT-PCR negatives

  90 days

• The serum anti-SARS-CoV-2 antibody titres

  90 days

• Detection of serum antibodies

  days 0, 3, 7, 14 and 90.

Study Arms (2)

Plasma

EXPERIMENTAL

Convalescent plasma from cured COVID-19 patients y Supportive management depending on individual needs

Biological: Plasma

Best Available Therapy

EXPERIMENTAL

Will receive supportive management depending on individual needs including.

Other: Best Available Therapy

Interventions

Plasma BIOLOGICAL

The plasma unit will be fractionated in 200 mL aliquots for storage at -80°C until use. After thawing, it shall be administered in a single 200 mL dose to subjects who are randomized to that arm.

Plasma

Best Available Therapy OTHER

It shall include, but not be limited to, oxygen therapy by means of a nasal cannula; high-flow nasal cannula; invasive or non-invasive mechanical ventilation; intravenous hydration; antibiotic therapy; thrombus prophylaxis; pain and fever management.

Best Available Therapy

Eligibility Criteria

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

You may qualify if:

• Men or women ≥18 years. If you are a woman of childbearing age, you must agree to practice abstinence or to use an effective method of contraception during the study period.
• Vascular access suitable for administration of hemocomponents.
• SARS-CoV-2 positive RT-PCR.
• Negative pregnancy test in case of a woman of reproductive age
• Signing of evidentiary document of informed consent.
• Hospital admission for SARS-CoV-2 pneumonia with supplemental oxygen requirements.
• Subjects who access the storage of biological samples for future examination.

You may not qualify if:

• Respiratory rate \>30 RPM, SO2 \<93%, PaO2/FiO2 \<200 despite intervention with oxygen therapy after 60 minutes of hospitalization.
• New alteration of the state of alert that does not revert after interventions 60 minutes after admission to hospital.
• PAM ≤ 65mmHg despite initial resuscitation on arrival at the centre.
• Pregnant or breastfeeding patients.
• Patients that the investigators consider inappropriate to participate in the clinical trial
• Contraindication to transfusion or history of previous severe reaction to blood products.
• Have received any blood products in the last 120 days.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario José E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (21)

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  BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Adrian Camacho-Ortiz, MD

  Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Infectious Disease Department

Model Details: RCT double blind comparative study

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: April 27, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

ME (1)