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

NCT04332835 | Completed Phase 2 DMC

• 1 other identifier: ABN011-2
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Coronavirus; Coronavirus Infection

Keywords

COVID-19; Coronavirus Disease 2019

Outcome Measures

Primary Outcomes (2)

• Change in Viral Load

  Copies of COVID-19 per ml

  Days 0, 4, 7, 14 and 28

• Change in Immunoglobulin G COVID-19 Titers

  Immunoglobulin G COVID-19 antibodies

  Days 0, 4, 7, 14 and 28

Secondary Outcomes (7)

• Intensive Care Unit Admission

  Days 7, 14 and 28

• Length of Intensive Care Unit stay

  Days 7, 14 and 28

• Length of hospital stay (days)

  Days 7, 14 and 28

• Requirement of mechanical ventilation

  Days 7, 14 and 28

• Duration (days) of mechanical ventilation

  Days 7, 14 and 28

Study Arms (2)

Intervention Group

EXPERIMENTAL

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. Simultaneously, they will receive the standard therapy defined by institutional protocol.

Drug: Plasma; Drug: Standard Therapy

Control Group

ACTIVE COMPARATOR

Participants included in the control group will receive standard therapy defined by institutional protocol.

Drug: Standard Therapy

Interventions

Plasma DRUG

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

Also known as: Convalescent Plasma COVID-19

Intervention Group

Standard Therapy DRUG

Standard therapy defined by institutional protocol.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Olerder than 18.
• Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.
• Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7)".
• Sequential Organ Failure Assessment score (SOFA) \< 6.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Female subjects who are pregnant or breastfeeding.
• Patients with prior allergic reactions to transfusions.
• Critical ill patients in intensive care units with requierment of Invasive Mechanical Venitlation.
• 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).
• Demonstrated coinfection that explains the patient's symptoms
• 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.

Sponsors & Collaborators

• Universidad del Rosario: lead
• Fundación Universitaria de Ciencias de la Salud: collaborator
• CES University: collaborator
• Instituto Distrital de Ciencia Biotecnología e Innovacion en Salud: collaborator

Study Sites (1)

Universidad del Rosario

Bogota, Cundinamarca, 11100, Colombia

Location

Related Publications (5)

• 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.

  PMID: 31986264 BACKGROUND

• 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.

  PMID: 32134116 BACKGROUND

• 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.

  PMID: 32125362 BACKGROUND

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

  BACKGROUND

• Rojas M, Rodriguez Y, Hernandez JC, Diaz-Coronado JC, Vergara JAD, Velez VP, Mancilla JP, Araujo I, Yepes JT, Ricaurte OB, Pardo-Oviedo JM, Monsalve DM, Acosta-Ampudia Y, Ramirez-Santana C, Garcia PG, Landinez LA, Correales LD, Grass JS, Perez CR, Lopez GS, Mateus N, Mancera L, Devia RR, Orjuela JE, Parra-Moreno CR, Buitrago AA, Ordonez IE, Osorio CF, Ballesteros N, Patino LH, Castaneda S, Munoz M, Ramirez JD, Bastard P, Gervais A, Bizien L, Casanova JL, Camacho B, Gallo JE, Gomez O, Rojas-Villarraga A, Perez CE, Manrique R, Mantilla RD, Anaya JM. Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel, controlled clinical study. BMC Infect Dis. 2022 Jun 27;22(1):575. doi: 10.1186/s12879-022-07560-7.

  PMID: 35761219 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

COVID-19 Serotherapy; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Juan M Anaya Cabrera, MD, PhD

  Universidad del Rosario

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 3, 2020
• Study Start: August 8, 2020
• Primary Completion: October 31, 2020
• Study Completion: November 15, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)