NCT04332380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2020

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

March 30, 2020

Last Update Submit

August 12, 2020

Conditions

CoronavirusCoronavirus Infection

Keywords

COVID-19Coronavirus Disease 2019

Outcome Measures

Primary Outcomes (3)

  • Change in Viral Load

    Copies of COVID-19 per ml

    Days 0, 4, 7, 14 and 28

  • Change in Immunoglobulin M COVID-19 antibodies Titers

    Immunoglobulin M COVID-19 antibodies

    Days 0, 4, 7, 14 and 28

  • Change in Immunoglobulin G COVID-19 antibodies 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

  • +2 more secondary outcomes

Study Arms (1)

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.

Drug: Plasma

Interventions

PlasmaDRUG

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

Also known as: Convalescent Plasma COVID-19
Intervention Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad del Rosario

Bogota, Cundinamarca, 11100, Colombia

Location

Related 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.

    PMID: 31986264BACKGROUND

  • 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: 32134116BACKGROUND

  • 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: 32125362BACKGROUND

  • 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

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Juan M Anaya Cabrera, MD, PhD

    Universidad del Rosario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Principal Investigator

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 2, 2020

Study Start

May 1, 2020

Primary Completion

July 28, 2020

Study Completion

July 28, 2020

Last Updated

August 17, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)