Skip to main content
OpenTrials
Completed

NCT Number: NCT04542967

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe COVID-19 Disease Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Central Militar

Mexico City, 11200, Mexico

About this study

A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Our primary outcomes will be disease progression and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Convalescent plasma

Primary outcomes

  1. Disease progression

    Time frame: Up to 30 days later from study entry

    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

  2. Side effects

    Time frame: Up to 30 days later from study entry

    Side effects associated with the administration of convalescent plasma

  3. Mortality

    Time frame: Up to 30 days later from study entry

    Any cause of death

Secondary outcomes

  1. Respiratory improvement

    Time frame: 10 days

    Change in partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio (PaO2/FiO2)

  2. Clinical improvement

    Time frame: 10 days

    Change in oxygen saturation levels

  3. Acute adverse events (AAE)

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

    Transfusion reactions during transfusion.

Other outcomes

  1. Inflammatory biomarkers (D dimer)

    Time frame: 10 days

    Change in pro-inflammatory biomarkers (D dimer μg/l)

  2. Inflammatory biomarkers (Ferritin)

    Time frame: 10 days

    Change in pro-inflammatory biomarkers ( Ferritin μg/L )

  3. Inflammatory biomarkers (CPR)

    Time frame: 10 days

    Change in pro-inflammatory biomarkers, C-reactive protein ( CPR mg/L )

  4. Inflammatory biomarkers (LDH)

    Time frame: 10 days

    Change in pro-inflammatory biomarkers, lactate dehydrogenase ( LDH UI/L)

Sponsors and collaborators

Lead sponsor

Hospital Central Militar

Other Gov

Registry information

Official study title

Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease

Acronym: PC-COVID-HCM

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2020
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.