NCT04621123

Brief Summary

This is a prospective, randomized (1:1), double blind study of Convalescent anti-SARS-CoV-2 MBT Plasma (also known as convalescent plasma) plus standard medical treatment (SMT) versus placebo plus SMT in mild or moderate COVID-19 patients who are non-hospitalised. Subjects with confirmed infection by SARS-CoV-2 will receive SMT plus a total of 200-300 mL of convalescent plasma that has been pathogen-inactivated using MBT or placebo. Approximately 474 individuals will be randomized (1:1) with an interim analysis after the first 60 subjects (30 in each arm). The sample size will be re-assessed upon interim analysis. Approximately 135 individuals from selected study sites will be included in the substudy to assess the immune response and the methods of sampling. This is a prospective, randomized (1:1), double blind study of Convalescent anti-SARS-CoV-2 MBT Plasma (also known as convalescent plasma) plus standard medical treatment (SMT) versus placebo plus SMT in mild or moderate COVID-19 patients who are non-hospitalised. Subjects with confirmed infection by SARS-CoV-2 will receive SMT plus a total of 200-300 mL of convalescent plasma that has been pathogen-inactivated using MBT or placebo. Approximately 474 individuals will be randomized (1:1) with an interim analysis after the first 60 subjects (30 in each arm). The sample size will be re-assessed upon interim analysis. Approximately 135 individuals from selected study sites will be included in the substudy to assess the immune response and the methods of sampling. The investigational product will be administered by IV infusion at baseline. Participants will continue their standard medical treatment (SMT) for SARS-CoV-2 infection as prescribed by their regular physician. If applicable, SMT may be modified during the study, depending on personal requirements, the severity and progression of the disease, and need for hospitalization. Subjects' participation (from inclusion/baseline visit to the end-of-study visit) will be up to 60 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

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

November 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

November 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2021

Completed
Last Updated

September 8, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

November 4, 2020

Last Update Submit

September 4, 2021

Conditions

SARS-CoV-2 InfectionSafety and Efficacy

Keywords

Convalescent anti-SARS-CoV-2 MBT PlasmaConvalescent plasmaSARS-CoV-2SafetyEfficacy

Outcome Measures

Primary Outcomes (2)

  • Hospitalization rate (safety and efficacy)

    Assess the therapeutic potential of early administration of convalescent MBT plasma in reducing the rate of hospitalization in non-hospitalised mild or moderate COVID-19 patients.

    Day 28

  • SARS-CoV-2 viral load (safety and efficacy)

    Assess the therapeutic potential of early administration of convalescent MBT plasma in reducing SARS-CoV-2 viral load at day 7, measured by quantitative RT-PCR (RT-qPCR) in non-hospitalised mild or moderate COVID-19 patients.

    Day 7

Secondary Outcomes (16)

  • COVID-19 WHO Clinical progression scale score (safety and efficacy)

    Day 60

  • COVID-19 symptoms severity score (safety and efficacy)

    Day 14

  • Resolution of symptoms (safety and efficacy)

    Day 28

  • Death rate (safety and efficacy)

    Day 60

  • Adverse events (AE) (safety and efficacy) Adverse events (AE) Adverse events (AE)

    Day 28

  • +11 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Subjects randomized to convalescent anti-SARS-CoV-2 MBT plasma plus SMT will receive one infusion of 200 to 300 ml of ABO-compatible convalescent plasma obtained from a convalescent donor.

Biological: Convalescent anti-SARS-CoV-2 MBT plasma

Control Group

PLACEBO COMPARATOR

Subjects randomized to placebo plus SMT will receive one infusion of 200 to 300 ml of sterile saline solution 0.9%.

Other: Control Group

Interventions

Convalescent anti-SARS-CoV-2 MBT plasmaBIOLOGICAL

Subjects randomized to combination convalescent anti-SARS-CoV-2 MBT plasma plus SMT will undergo an ABO compatibility test and will receive a single infusion of 200 to 300 ml of ABO-compatible convalescent plasma

Experimental group
Control GroupOTHER

Subjects randomized to placebo plus SMT will receive one infusion of 200 to 300ml of sterile saline solution 0.9%.

Also known as: Sterile saline solution 0.9%
Control Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Adult male or female individuals of ≥50 years old.
  • a. Mild COVID-19: Individuals who have any of the common signs and/or symptoms of COVID-19 (i.e., fever, cough, sore throat, malaise, headache, muscle pain) without shortness of breath, dyspnoea, or abnormal chest imaging.
  • Moderate COVID-19: Individuals who have evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (SpO2) ≥94% on room air at sea level.
  • \. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
  • \. Has understood the information provided and capable of giving informed consent.
  • A woman will be considered of childbearing potential if not permanently sterilized nor postmenopausal. Permanent sterilization methods include tubal ligation, hysterectomy and bilateral oophorectomy. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
  • PanbioTM COVID-19 Ag Rapid Test (Abbott), STANDARDTM Q COVID-19 Ag Test (Roche) or any other CE marketed test for SARS-CoV-2 Ag detection.

You may not qualify if:

  • If female, pregnant, breastfeeding, or planning a pregnancy during the study.
  • Severe or critical COVID-19:
  • Severe COVID-19: respiratory frequency \>30 breaths per minute, SpO2 \<94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<300 mmHg, or lung infiltrates \>50%.
  • Critical COVID-19: respiratory failure, septic shock, and/or multiple organ dysfunction.
  • Current hospital admission for any cause.
  • History of previous confirmed SARS-CoV-2 infection.
  • History of significantly abnormal liver function (Child Pugh C).
  • History of chronic kidney disease (CKD) ≥ stage 4, or need of dialysis treatment.
  • Any pre-existing condition that increases risk of thrombosis.
  • History of allergic reactions to blood or plasma products or methylene blue.
  • Known IgA deficiency with anti-IgA antibodies.
  • Medical conditions for which 300ml of intravenous fluid is considered dangerous (i.e., decompensated heart failure or renal failure with fluid overload).
  • Inability to consent and/or comply with study requirements, in the opinion of the investigator.
  • Currently participating or planning to participate in any interventional study for the treatment of COVID-19 or SARS-CoV-2 infection until day 60.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Hospital Sant Bernabé (Hospital de Berga)

Berga, Barcelona, 08600, Spain

Location

CUAP Manresa (Planta 0 del CAP Bages)

Manresa, Barcelona, 08042, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Related Publications (3)

  • Alemany A, Ouchi D, Pradenas E, Aguilar R, Vidal M, Jimenez A, Millat-Martinez P, Corbacho-Monne M, Suner C, Bassat Q, Baro B, Moncunill G, Mitja O; COnV-ert Group of Authors; Blanco J, Dobano C. Patient and donor antibody profiles in early COVID-19 convalescent plasma therapy in the COnV-ert trial. Front Immunol. 2025 Sep 25;16:1647488. doi: 10.3389/fimmu.2025.1647488. eCollection 2025.

    PMID: 41080591DERIVED

  • Millat-Martinez P, Gharbharan A, Alemany A, Rokx C, Geurtsvankessel C, Papageorgiou G, van Geloven N, Jordans C, Groeneveld G, Swaneveld F, van der Schoot E, Corbacho-Monne M, Ouchi D, Piccolo Ferreira F, Malchair P, Videla S, Garcia Garcia V, Ruiz-Comellas A, Ramirez-Morros A, Rodriguez Codina J, Amado Simon R, Grifols JR, Blanco J, Blanco I, Ara J, Bassat Q, Clotet B, Baro B, Troxel A, Zwaginga JJ, Mitja O, Rijnders BJA; CoV-Early study group; COnV-ert study group. Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients. Nat Commun. 2022 May 11;13(1):2583. doi: 10.1038/s41467-022-29911-3.

    PMID: 35546145DERIVED

  • Alemany A, Millat-Martinez P, Corbacho-Monne M, Malchair P, Ouchi D, Ruiz-Comellas A, Ramirez-Morros A, Rodriguez Codina J, Amado Simon R, Videla S, Costes G, Capdevila-Jauregui M, Torrano-Soler P, San Jose A, Bonet Papell G, Puig J, Otero A, Ruibal Suarez JC, Zarauza Pellejero A, Llopis Roca F, Rodriguez Cortez O, Garcia Garcia V, Vidal-Alaball J, Millan A, Contreras E, Grifols JR, Ancochea A, Galvan-Femenia I, Piccolo Ferreira F, Bonet M, Cantoni J, Prat N, Ara J, Forcada Arcarons A, Farre M, Pradenas E, Blanco J, Angel Rodriguez-Arias M, Fernandez Rivas G, Marks M, Bassat Q, Blanco I, Baro B, Clotet B, Mitja O; CONV-ERT Group. High-titre methylene blue-treated convalescent plasma as an early treatment for outpatients with COVID-19: a randomised, placebo-controlled trial. Lancet Respir Med. 2022 Mar;10(3):278-288. doi: 10.1016/S2213-2600(21)00545-2. Epub 2022 Feb 9.

    PMID: 35150610DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized (1:1), double blind study of Convalescent anti-SARS-CoV-2 MBT Plasma (also known as convalescent plasma) plus standard medical treatment (SMT) versus placebo plus SMT in mild or moderate COVID-19 patients who are non-hospitalised. Subjects will be followed up to 60 days after infusion
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 9, 2020

Study Start

November 10, 2020

Primary Completion

May 31, 2021

Study Completion

July 28, 2021

Last Updated

September 8, 2021

Record last verified: 2021-09

Locations

ES(4)