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Convalescent Plasma for Patients With COVID-19: A Pilot Study (CP-COVID-19)

Primary Purpose

Coronavirus, Coronavirus Infection

Status

Completed

Phase

Phase 2

Locations

Colombia

Study Type

Interventional

Intervention

Plasma

About this trial

This is an interventional treatment trial for Coronavirus focused on measuring COVID-19, Coronavirus Disease 2019

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Fulfilling all the following criteria

Aged between 18 and 60 years, male or female.
Hospitalized participants with diagnosis for COVID 19 by Real Time - Polymerase Chain Reaction.
Without treatment.
Moderate cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)".
Confusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) >= 2.
Sequential Organ Failure Assessment score (SOFA) < 6.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Female subjects who are pregnant or breastfeeding.
Patients with prior allergic reactions to transfusions.
Critical ill patients in intensive care units.
Patients with surgical procedures in the last 30 days.
Patients with active treatment for cancer (Radiotherapy or Chemotherapy).
HIV diagnosed patients with viral failure (detectable viral load> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).
Patients who have suspicion or evidence of coinfections.
End-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2).
Child Pugh C stage liver cirrhosis.
High cardiac output diseases.
Autoimmune diseases or Immunoglobulin A nephropathy.
Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.

Sites / Locations

Universidad del Rosario

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

Participants included in the experimental group will receive 500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day after starting the protocol.

Outcomes

Primary Outcome Measures

Change in Viral Load

Copies of COVID-19 per ml

Change in Immunoglobulin M COVID-19 antibodies Titers

Immunoglobulin M COVID-19 antibodies

Change in Immunoglobulin G COVID-19 antibodies Titers

Immunoglobulin G COVID-19 antibodies

Secondary Outcome Measures

Intensive Care Unit Admission

Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)

Length of Intensive Care Unit stay

Days of Intensive Care Unit management (days 7, 14 and 28)

Length of hospital stay (days)

Days of Hospitalization (days 7, 14 and 28)

Requirement of mechanical ventilation

Proportion of patients with mechanical ventilation (days 7, 14 and 28)

Duration (days) of mechanical ventilation

Days with mechanical ventilation (days 7, 14 and 28)

Clinical status assessed according to the World Health Organization guideline

1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)

Mortality

Proportión of death patients at days 7, 14 and 28

Full Information

NCT ID

NCT04332380

First Posted

March 30, 2020

Last Updated

August 12, 2020

Sponsor

Universidad del Rosario

Collaborators

CES University, Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud, Fundación Universitaria de Ciencias de la Salud

1. Study Identification

Unique Protocol Identification Number

NCT04332380

Brief Title

Convalescent Plasma for Patients With COVID-19: A Pilot Study

Acronym

CP-COVID-19

Official Title

Convalescent Plasma for Patients With COVID-19: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

July 28, 2020 (Actual)

Study Completion Date

July 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad del Rosario

Collaborators

CES University, Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud, Fundación Universitaria de Ciencias de la Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks.

Detailed Description

The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus, Coronavirus Infection

Keywords

COVID-19, Coronavirus Disease 2019

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Plasma

Other Intervention Name(s)

Convalescent Plasma COVID-19

Intervention Description

Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.

Primary Outcome Measure Information:

Title

Change in Viral Load

Description

Copies of COVID-19 per ml

Time Frame

Days 0, 4, 7, 14 and 28

Title

Change in Immunoglobulin M COVID-19 antibodies Titers

Description

Immunoglobulin M COVID-19 antibodies

Time Frame

Days 0, 4, 7, 14 and 28

Title

Change in Immunoglobulin G COVID-19 antibodies Titers

Description

Immunoglobulin G COVID-19 antibodies

Time Frame

Days 0, 4, 7, 14 and 28

Secondary Outcome Measure Information:

Title

Intensive Care Unit Admission

Description

Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)

Time Frame

Days 7, 14 and 28

Title

Length of Intensive Care Unit stay

Description

Days of Intensive Care Unit management (days 7, 14 and 28)

Time Frame

Days 7, 14 and 28

Title

Length of hospital stay (days)

Description

Days of Hospitalization (days 7, 14 and 28)

Time Frame

Days 7, 14 and 28

Title

Requirement of mechanical ventilation

Description

Proportion of patients with mechanical ventilation (days 7, 14 and 28)

Time Frame

Days 7, 14 and 28

Title

Duration (days) of mechanical ventilation

Description

Days with mechanical ventilation (days 7, 14 and 28)

Time Frame

Days 7, 14 and 28

Title

Clinical status assessed according to the World Health Organization guideline

Description

Time Frame

Days 7, 14 and 28

Title

Mortality

Description

Proportión of death patients at days 7, 14 and 28

Time Frame

Days 7, 14 and 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:Fulfilling all the following criteria Aged between 18 and 60 years, male or female. Hospitalized participants with diagnosis for COVID 19 by Real Time - Polymerase Chain Reaction. Without treatment. Moderate cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)". Confusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) >= 2. Sequential Organ Failure Assessment score (SOFA) < 6. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Female subjects who are pregnant or breastfeeding. Patients with prior allergic reactions to transfusions. Critical ill patients in intensive care units. Patients with surgical procedures in the last 30 days. Patients with active treatment for cancer (Radiotherapy or Chemotherapy). HIV diagnosed patients with viral failure (detectable viral load> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals). Patients who have suspicion or evidence of coinfections. End-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2). Child Pugh C stage liver cirrhosis. High cardiac output diseases. Autoimmune diseases or Immunoglobulin A nephropathy. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan M Anaya Cabrera, MD, PhD

Organizational Affiliation

Universidad del Rosario

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universidad del Rosario

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

11100

Country

Colombia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31986264

Citation

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:

Results Reference

background

PubMed Identifier

32134116

Citation

Wang Y, Wang Y, Chen Y, Qin Q. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. J Med Virol. 2020 Jun;92(6):568-576. doi: 10.1002/jmv.25748. Epub 2020 Mar 29.

Results Reference

background

PubMed Identifier

32125362

Citation

Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204. Erratum In: JAMA. 2020 Apr 21;323(15):1510.

Results Reference

background

Citation

Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020).

Results Reference

background

Links:

URL

https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds

Description

FDA recommendations for convalescent plasma clinical research

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Convalescent Plasma for Patients With COVID-19: A Pilot Study

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