NCT04395170

Brief Summary

A randomized, open-label, multicenter, three-arm clinical trial to study the efficacy and safety of passive immunotherapy (convalescent plasma and anti-COVID-19 human immunoglobulin) compared to the standard treatment in Colombia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

May 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

May 15, 2020

Last Update Submit

July 8, 2020

Conditions

Coronavirus Disease 2019 (COVID-19)

Keywords

coronavirus

Outcome Measures

Primary Outcomes (1)

  • Admission to ICU and/or mechanical ventilation

    Admission to the intensive care unit with the requirement of mechanical ventilation (invasive or non-invasive) due to Acute Respiratory Distress Syndrome by COVID-19.

    One year

Secondary Outcomes (4)

  • Length of hospital stay

    One year

  • Neutralizing antibody (IgG) titers against COVID-19

    One year

  • Safety - Adverse events

    One year

  • Death

    One year

Study Arms (3)

Convalescent plasma

EXPERIMENTAL

Plasma from patients recovering from COVID-19.

Biological: COVID-19 convalescent plasma

Anti-COVID-19 human immunoglobulin

EXPERIMENTAL

Anti-COVID-19 human immunoglobulin to be administered intravenously.

Biological: Anti-COVID-19 human immunoglobulin

Standard (specific) therapy

ACTIVE COMPARATOR

Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities. To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin.

Drug: Standard (specific) therapy for COVID-19

Interventions

COVID-19 convalescent plasmaBIOLOGICAL

Plasma from convalescent patients with COVID-19 and at the same time receiving supportive therapy, with inactivation / reduction of pathogens, in the scheme of two doses of 200 - 250 mL administered on days 1 and 3 of the intervention.

Convalescent plasma
Anti-COVID-19 human immunoglobulinBIOLOGICAL

Anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenously at a dose of immunoglobulin 10% IgG solution (10% mL vial) for: Patient of 50 Kg or more, a dose of 50 mL, administered on days 1 and 3 of treatment. Patient under 50 Kg, the dose will be 1 mL / Kg, administered on days 1 and 3 of treatment. The supply of anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S included once it has been authorized by INVIMA and/or the regulatory requirements in force for the production of drugs are met.

Anti-COVID-19 human immunoglobulin
Standard (specific) therapy for COVID-19DRUG

Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities. To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin.

Standard (specific) therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obtaining the informed written consent before carrying out the study procedures, by the patients.
  • Adult patients ≥18 years at the time of recruitment for the study.
  • Patients with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction on nasal/oropharyngeal swabs or any other relevant specimen \<72 hours before randomization.
  • Patients requiring hospitalization for COVID-19 without mechanical ventilation (invasive or non-invasive, including an oxygen mask with reserve bag) and at least one of the following:
  • Radiographic evidence of pulmonary infiltrates by images (chest radiography, computed tomography, etc.),
  • Clinical evaluation (evidence of rales/crackles on examination) and oxygen saturation ≤ 94% in ambient air requiring supplemental oxygen.
  • Patient with no more than 72 hours (3 days) of hospitalization prior to the administration of PC treatment (except the days after initial hospital admission for other reasons and prior to COVID-19 infection).
  • Patients who do not have more than 10 days between the onset of symptoms (fever or cough) and the day of administration of treatment or the demonstration of the absence of anti-SARS-CoV-2 antibodies (patients with more than 10 days of symptoms they can only be included if a negative antibody result has been confirmed).

You may not qualify if:

  • Patient in a state of pregnancy.
  • Require mechanical ventilation (invasive or non-invasive, including oxygen mask with reserve bag) on examination.
  • Participation in any other clinical trial of an experimental treatment for COVID-19.
  • At the discretion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, regardless of the provision of treatments.
  • Any incompatibility or allergy to the administration of plasma of human origin.
  • Severe chronic kidney disease in stage 4 or requiring dialysis (that is, glomerular filtration rate \<30).
  • Any condition that in the investigator's opinion limits participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LifeFactors Zona Franca SAS

Medellín, Antioquia, Colombia

Location

Related Publications (14)

  • Cancer Institute N. Common Terminology Criteria for Adverse Events (CTCAE) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [Internet]. 2017. Available from: https://www.meddra.org/

    BACKGROUND

  • Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.

    PMID: 25030060RESULT

  • Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.

    PMID: 15616839RESULT

  • Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x.

    PMID: 15214887RESULT

  • Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.

    PMID: 32253318RESULT

  • Francis F, Hall M, Surg, Gaines A. Early use of convalescent serum in influenza. Mil Surg. 1920;47:177-9.

    RESULT

  • rice H, Genereux M, Sinclair C. Hyperimmune Immunoglobulin G. In: Production of Plasma Proteins for Therapeutic Use [Internet]. Hoboken, NJ, USA: John Wiley & Sons, Inc.; 2012.

    RESULT

  • Vargas M, Segura A, Wu YW, Herrera M, Chou ML, Villalta M, Leon G, Burnouf T. Human plasma-derived immunoglobulin G fractionated by an aqueous two-phase system, caprylic acid precipitation, and membrane chromatography has a high purity level and is free of detectable in vitro thrombogenic activity. Vox Sang. 2015 Feb;108(2):169-77. doi: 10.1111/vox.12209. Epub 2014 Dec 3.

    PMID: 25469648RESULT

  • Redden WR. Treatment of Influenza-Pneumonia by Use of Convalescent Human Serum. Bost Med Surg J. 1919 Dec 11;181(24):688-91.

    RESULT

  • Wong VW, Dai D, Wu AK, Sung JJ. Treatment of severe acute respiratory syndrome with convalescent plasma. Hong Kong Med J. 2003 Jun;9(3):199-201.

    PMID: 12777656RESULT

  • van Griensven J, Edwards T, Baize S; Ebola-Tx Consortium. Efficacy of Convalescent Plasma in Relation to Dose of Ebola Virus Antibodies. N Engl J Med. 2016 Dec 8;375(23):2307-2309. doi: 10.1056/NEJMc1609116. Epub 2016 Nov 14. No abstract available.

    PMID: 27959686RESULT

  • Zingher A, Mortimer P. Convalescent whole blood, plasma and serum in the prophylaxis of measles: JAMA, 12 April, 1926; 1180-1187. Rev Med Virol. 2005 Nov-Dec;15(6):407-18; discussion 418-21. doi: 10.1002/rmv.480. No abstract available.

    PMID: 16211552RESULT

  • Use of Convalescent Whole Blood or Plasma Collected from Patients Recovered from Ebola Virus Disease for Transfusion, as an Empirical Treatment during Outbreaks Interim Guidance for National Health Authorities and Blood Transfusion Services Use of Convale. 2014.

    RESULT

  • FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency | FDA [Internet]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency

    RESULT

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

COVID-19 SerotherapyTherapeutics

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyImmunologic TechniquesInvestigative Techniques

Central Study Contacts

Santiago Jaramillo

CONTACT

+573128092776sjaramillo@lifefactors.co

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 20, 2020

Study Start

September 1, 2020

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

July 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

No.

Locations

CO(1)