Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study

Coronavirus Clinical Trial

— CP-COVID-19  

Official title:

Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332835
• Other study ID #: ABN011-2
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 8, 2020
• Est. completion date: November 15, 2020

Study information

• Verified date: November 2020
• Source: Universidad del Rosario
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 15, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:Fulfilling all the following criteria

1. Olerder than 18.

2. Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.

3. Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7)".

4. Sequential Organ Failure Assessment score (SOFA) < 6.

5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding.

2. Patients with prior allergic reactions to transfusions.

3. Critical ill patients in intensive care units with requierment of Invasive Mechanical Venitlation.

4. Patients with surgical procedures in the last 30 days.

5. Patients with active treatment for cancer (Radiotherapy or Chemotherapy).

6. 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).

7. Demonstrated coinfection that explains the patient's symptoms

8. End-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2).

9. Child Pugh C stage liver cirrhosis.

10. High cardiac output diseases.

11. Autoimmune diseases or Immunoglobulin A nephropathy.

12. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Plasma
Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
• Standard Therapy
Standard therapy defined by institutional protocol.

Locations

Country	Name	City	State
Colombia	Universidad del Rosario	Bogota	Cundinamarca

Sponsors (4)

Lead Sponsor	Collaborator
Universidad del Rosario	CES University, Fundación Universitaria de Ciencias de la Salud, Instituto Distrital de Ciencia Biotecnología e Innovacion en Salud

Country where clinical trial is conducted

Colombia, 

References & Publications (4)

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;:. — View 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)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Viral Load	Copies of COVID-19 per ml	Days 0, 4, 7, 14 and 28
Primary	Change in Immunoglobulin G COVID-19 Titers	Immunoglobulin G COVID-19 antibodies	Days 0, 4, 7, 14 and 28
Secondary	Intensive Care Unit Admission	Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)	Days 7, 14 and 28
Secondary	Length of Intensive Care Unit stay	Days of Intensive Care Unit management (days 7, 14 and 28)	Days 7, 14 and 28
Secondary	Length of hospital stay (days)	Days of Hospitalization (days 7, 14 and 28)	Days 7, 14 and 28
Secondary	Requirement of mechanical ventilation	Proportion of patients with mechanical ventilation (days 7, 14 and 28)	Days 7, 14 and 28
Secondary	Duration (days) of mechanical ventilation	Days with mechanical ventilation (days 7, 14 and 28)	Days 7, 14 and 28
Secondary	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)	Days 7, 14 and 28
Secondary	Mortality	Proportion of death patients at days 7, 14 and 28	Days 7, 14 and 28

External Links

•   FDA recommendations for convalescent plasma clinical research