Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease

NCT04542967 | Completed Phase 2 DMC

• 1 other identifier: 047/2020
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.

Conditions

Severe COVID-19 Disease

Keywords

SARS-CoV2; Convalescent Plasma; Severe Acute Respiratory Syndrome

Outcome Measures

Primary Outcomes (3)

• Disease progression

  Change in ordinal Scale for Clinical Improvement (WHO). The progression disease, its the change in the severity score; a bigger number to the obtained after randomization

  Up to 30 days later from study entry

• Side effects

  Side effects associated with the administration of convalescent plasma

  Up to 30 days later from study entry

• Mortality

  Any cause of death

  Up to 30 days later from study entry

Secondary Outcomes (3)

• Respiratory improvement

  10 days

• Clinical improvement

  10 days

• Acute adverse events (AAE)

  After receiving intervention, an average time one hour, until 24 hours after administration.

Other Outcomes (4)

• Inflammatory biomarkers (D dimer)

  10 days

• Inflammatory biomarkers (Ferritin)

  10 days

• Inflammatory biomarkers (CPR)

  10 days

Study Arms (2)

Control group

NO INTERVENTION

They will receive the standard care for critically ill inpatients.

Convalescent plasma group.

EXPERIMENTAL

They will receive standard care for patients with severe COVID-19 disease and convalescent plasma disease.

Biological: Biological

Interventions

Biological BIOLOGICAL

An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses. If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out.

Also known as: Convalescent plasma

Convalescent plasma group.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• O2 saturation \<93%
• Radiographic evidence of moderate pneumonia according to Rale's classification.
• Acute respiratory distress syndrome (PaO2 / FiO2 \<300 or SpO2 / FiO2 ≤ 315)
• Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated)

You may not qualify if:

• Pregnant patients
• History of transfusion reactions
• Patients with congestive heart failure
• Patients with a history of chronic kidney failure on dialysis
• Patients with multiple organ failure
• Patients who does not accept or agree with the treatment.

Sponsors & Collaborators

• Hospital Central Militar: lead

Study Sites (1)

Hospital Central Militar

Mexico City, 11200, Mexico

Location

Related Links

• Clinical Characteristics of Coronavirus Disease 2019 in China
• Potential interventions for novel coronavirus in China: A systematic review
• Use of convalescent plasma therapy in SARS patients in Hong Kong

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Carmen G Torres, MD

  Hospital Central Militar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research was blinded as possible for the result's evaluators and those responsible for the statistical analysis. All patients admitted to the investigation were placed with a marker indicating that they were a patient of the plasma protocol, but not mention the study group. The data collectors and the outcome adjudicators were unaware of the treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The PC-COVID-HCM clinical trial is a randomized, controlled, single-blind study .

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 9, 2020
• Study Start: June 23, 2020
• Primary Completion: September 2, 2020
• Study Completion: September 30, 2020
• Last Updated: May 10, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From 6 months after publication
• Access Criteria: PRIOR APPLICATION

Locations

ME (1)