SARS-CoV-2 InfectionPhase 2NCT04621123
Plasma for Early Treatment in Non-hospitalised Mild or Moderate COVID-19 Patients
A Phase 2 study testing Convalescent anti-SARS-CoV-2 MBT plasma in people with SARS-CoV-2 Infection and Safety and Efficacy, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, Safety and Efficacy
- What is being tested?
- Convalescent anti-SARS-CoV-2 MBT plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 4 sitesSpain
- Study dates
- 10 Nov 2020to 28 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult male or female individuals of ≥50 years old.
- 2. In women of childbearing potential1, negative pregnancy test at inclusion/baseline.
- 3. Has confirmed SARS-CoV-2 infection as determined by PCR or validated antigen rapid diagnostic test2 from nasopharyngeal swabs ≤5 days prior to inclusion/baseline visit.
- 4. Symptomatic with mild or moderate COVID-19 with symptoms onset date ≤ 7 days prior to inclusion/baseline visit.
- 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.
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- 5. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- 6. Has understood the information provided and capable of giving informed consent.
- 1 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.
- 2 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital Sant Bernabé (Hospital de Berga)
Berga, Barcelona, 08600
CUAP Manresa (Planta 0 del CAP Bages)
Manresa, Barcelona, 08042
About this study
Official title: Convalescent Methylene Blue Treated (MBT) Plasma for Early Treatment in Non-hospitalised Mild or Moderate COVID-19 Patients: a Randomized Double Blind Study (COnV-ert)
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).
Read more
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.
Read the detailed description
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.
Study candidates will voluntarily express their interest in participating in the study through the study website or will be offered to participate at the emergency (ER) and out-patient departments (OPD) of the participating hospitals. Candidates registered on the website will be contacted by study physicians by phone to inform them about the study and check their suitability for the study. Suitable candidates will be scheduled an inclusion/baseline visit in which informed consent will be obtained (i.e., the paper informed consent will be signed), and their eligibility will be confirmed. Candidates identified through ER and OPD departments will undergo an inclusion/baseline visit, where the informed consent will be obtained and eligibility will be checked. A subgroup of eligible candidates from selected study sites will be offered participation in the substudy to assess the immune response and the methods of sampling.
Blood and nasopharyngeal samples will be obtained from all eligible candidates. Eligible candidates will be randomized and administered an intravenous (IV) infusion at baseline (convalescent plasma or placebo). Both the investigator and the participant will be blinded to the study treatment.
Specifically, 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. Subjects randomized to placebo plus SMT will receive a single infusion of 200 to 300 ml of sterile saline solution 0.9%. Infusion will be administered at baseline, using standard procedures for administration of fresh frozen plasma. Small adults weighing less than 45 kg will receive one infusion of 5 ml of convalescent plasma or placebo per kilogram of body weight.
Participants will be trained on the completion of symptoms diary card and safety diary card.
The participants of the substudy will be drawn an extra tube of blood sample and will be trained on self-collection of middle turbinate (MT) swabs and saliva, and self-collected samples will be obtained.
The symptoms and safety diary card will be filled by the participants daily from baseline to day 14. On follow-up visits on days 3, 7, 14, and 28, all participants will be assessed for clinical and safety outcomes. These visits will be all by telephone except for the day 7 and day 28 visits that will be at home and at hospital, respectively, where additionally blood samples (only on day 7) and nasopharyngeal swabs will be collected.
At day 60 visit, all participants will be assessed by telephone for health-status outcome.
For the participants of the substudy, on day 7, an extra tube of blood sample will be obtained and they will be asked to self-collect MT swabs and saliva. And on day 60, an extra tube of blood sample will be obtained during an additional home or hospital visit.
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.
- Conditions
- SARS-CoV-2 Infection, Safety and Efficacy
- Being tested
- Convalescent anti-SARS-CoV-2 MBT plasma, Control Group
- Keywords
- Convalescent anti-SARS-CoV-2 MBT Plasma, Convalescent plasma, SARS-CoV-2, Safety, Efficacy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Control GroupOther
Also called Sterile saline solution 0.9%
Subjects randomized to placebo plus SMT will receive one infusion of 200 to 300ml of sterile saline solution 0.9%.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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%. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 7
Secondary outcomes (16)
COVID-19 WHO Clinical progression scale score (safety and efficacy)
Change in COVID-19 World Health Organization WHO Clinical progression scale score to assess hospitalization rate (i.e. who reach a score ≥4).
- Minimum to maximum scores below:
- Score 0 (uninfected) - Uninfected; no viral RNA detected
- Score 1 (ambulatory mild disease) - Asymptomatic; viral RNA detected
- Score 2 (ambulatory mild disease) - Symptomatic; independent
- Score 3 (ambulatory mild disease) - Symptomatic; assistance needed
- Score 4 (hospitalised: moderate disease) - Hospitalised; no oxygen therapy
- Score 5 (hospitalised: moderate disease) - Hospitalised; oxygen by mask or nasal prongs
- Score 6 (hospitalised: severe diseases) - Hospitalised; oxygen by NIV or high flow
- Score 7 (hospitalised: severe diseases) - Intubation Score 8 (hospitalised: severe diseases) - Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors
- and mechanical ventilation, pO2/FiO2 ≥150 or SpO2/FiO2 ≥200
Measured: Day 60
COVID-19 symptoms severity score (safety and efficacy)
Change in COVID-19 symptoms severity score, assessed with the COVID-19 daily self-score tool (FLU- patient-reported outcome measure (FLU-PRO©) PLUS instrument), certified-Spanish translation. COVID-19 daily self-score tool to assess symptom severity across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Data on the presence/absence of symptoms, symptom profiles, and change over time.
Items 1-27 are Likert scale questions to score symptom severity (rated 0-4): 0=not at all;4=very much. Items 28-32 are also Likert scale questions (rated 0-4) measuring frequency of specific daily symptoms: 0=never or 0 times;4=always or 4 times. Items 33 and 34 measure the presence/absence of COVID-19 specific symptoms: 0=no;1=yes. Total maximum score of FLU-PRO© PLUS 134
Measured: Day 14
Resolution of symptoms (safety and efficacy)
Time to complete resolution of symptoms
Measured: Day 28
Death rate (safety and efficacy)
Death rate
Measured: Day 60
Adverse events (AE) (safety and efficacy) Adverse events (AE) Adverse events (AE)
Proportion of patients with adverse events (AE) and proportion of grade ≥4 AE, based on the FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers scale
Measured: Day 28
Ferritin (safety and efficacy)
Change in inflammatory prognostic markers (ferritin)
Measured: Baseline and Day 7
Prealbumin (safety and efficacy)
Change in inflammatory prognostic markers (prealbumin)
Measured: Baseline and Day 7
Interleukin 6 (IL-6) (safety and efficacy)
Change in inflammatory prognostic markers (Interleukin 6 (IL-6))
Measured: Baseline and Day 7
D-dimer (safety and efficacy)
Change in inflammatory prognostic markers (D-dimer)
Measured: Baseline and Day 7
C reactive protein (CRP) (safety and efficacy)
Change in inflammatory prognostic markers (C reactive protein (CRP))
Measured: Baseline and Day 7
Leukocyte count (safety and efficacy)
Change in inflammatory prognostic markers (Leukocyte count)
Measured: Baseline and Day 7
Lymphocyte count (safety and efficacy)
Change in inflammatory prognostic markers (Lymphocyte count)
Measured: Baseline and Day 7
Absolute neutralization titers against SARS-CoV-2 in plasma (safety and efficacy)
Intergroup comparison of absolute neutralization titers against SARS-CoV-2 in plasma in a subgroup of 135 participants
Measured: Baseline and Day 7
Titers of neutralizing antibodies against SARS-CoV-2 in plasma (safety and efficacy)
Change in titers of neutralizing antibodies against SARS-CoV-2 in plasma in a subgroup of 135 participants
Measured: Baseline and Day 60
SARS-CoV-2 viral load of self-collected middle turbinate (MT) swab and saliva samples compared to nasopharyngeal swabs collected by a healthcare worker (safety and efficacy)
Agreement and SARS-CoV-2 viral load of self-collected middle turbinate (MT) swab and saliva samples compared to nasopharyngeal swabs collected by a healthcare worker in a subgroup of 135 participants
Outcome 18: Secondary Outcome Measure:
Measured: Baseline and Day 7
Reduction of SARS-CoV-2 viral load (safety and efficacy)
Reduction of SARS-CoV-2 viral load in nasopharyngeal swabs at day 28 after start of treatment, as determined by RT-qPCR
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start10 Nov 2020
- Primary completion31 May 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, IrsiCaixa, Banc de Sang i Teixits, Grifols Biologicals, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621123
- Sponsor's protocol ID
- COnV-ert
- Status last verified
- Sep 2021
- First submitted
- 4 Nov 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41080591Millat-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.
PubMed 35546145Alemany 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.
PubMed 35150610
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Methylene Blue Treated (MBT) Plasma for Early Treatment in Non-hospitalised Mild or Moderate COVID-19 Patients: a Randomized Double Blind Study (COnV-ert)
- ClinicalTrials.gov ID
- NCT04621123
- Acronym / sponsor ID
- COnV-ert
- Conditions
- SARS-CoV-2 Infection, Safety and Efficacy
- Keywords
- Convalescent anti-SARS-CoV-2 MBT Plasma, Convalescent plasma, SARS-CoV-2, Safety, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, IrsiCaixa, Banc de Sang i Teixits, Grifols Biologicals, LLC
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study candidates will voluntarily express their interest in participating in the study through the study website or will be offered to participate at the emergency (ER) and out-patient departments (OPD) of the participating hospitals. Candidates registered on the website will be contacted by study physicians by phone to inform them about the study and check their suitability for the study. Suitable candidates will be scheduled an inclusion/baseline visit in which informed consent will be obtained (i.e., the paper informed consent will be signed), and their eligibility will be confirmed. Candidates identified through ER and OPD departments will undergo an inclusion/baseline visit, where the informed consent will be obtained and eligibility will be checked. A subgroup of eligible candidates from selected study sites will be offered participation in the substudy to assess the immune response and the methods of sampling.
Blood and nasopharyngeal samples will be obtained from all eligible candidates. Eligible candidates will be randomized and administered an intravenous (IV) infusion at baseline (convalescent plasma or placebo). Both the investigator and the participant will be blinded to the study treatment.
Specifically, 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. Subjects randomized to placebo plus SMT will receive a single infusion of 200 to 300 ml of sterile saline solution 0.9%. Infusion will be administered at baseline, using standard procedures for administration of fresh frozen plasma. Small adults weighing less than 45 kg will receive one infusion of 5 ml of convalescent plasma or placebo per kilogram of body weight.
Participants will be trained on the completion of symptoms diary card and safety diary card.
The participants of the substudy will be drawn an extra tube of blood sample and will be trained on self-collection of middle turbinate (MT) swabs and saliva, and self-collected samples will be obtained.
The symptoms and safety diary card will be filled by the participants daily from baseline to day 14. On follow-up visits on days 3, 7, 14, and 28, all participants will be assessed for clinical and safety outcomes. These visits will be all by telephone except for the day 7 and day 28 visits that will be at home and at hospital, respectively, where additionally blood samples (only on day 7) and nasopharyngeal swabs will be collected.
At day 60 visit, all participants will be assessed by telephone for health-status outcome.
For the participants of the substudy, on day 7, an extra tube of blood sample will be obtained and they will be asked to self-collect MT swabs and saliva. And on day 60, an extra tube of blood sample will be obtained during an additional home or hospital visit.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Convalescent anti-SARS-CoV-2 MBT plasmaSubjects 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. |
| Control Group | Placebo comparator | Other: Control GroupSubjects randomized to placebo plus SMT will receive one infusion of 200 to 300 ml of sterile saline solution 0.9%. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Adult male or female individuals of ≥50 years old.
- 2. In women of childbearing potential1, negative pregnancy test at inclusion/baseline.
- 3. Has confirmed SARS-CoV-2 infection as determined by PCR or validated antigen rapid diagnostic test2 from nasopharyngeal swabs ≤5 days prior to inclusion/baseline visit.
- 4. Symptomatic with mild or moderate COVID-19 with symptoms onset date ≤ 7 days prior to inclusion/baseline visit.
- 5. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
Key exclusion criteria (14 listed)
- If female, pregnant, breastfeeding, or planning a pregnancy during the study.
- Severe or critical COVID-19:
- Current hospital admission for any cause.
- History of previous confirmed SARS-CoV-2 infection.
- History of significantly abnormal liver function (Child Pugh C).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Convalescent anti-SARS-CoV-2 MBT plasmaSubjects 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 | Biological | Experimental group |
| Control GroupAlso: Sterile saline solution 0.9%Subjects randomized to placebo plus SMT will receive one infusion of 200 to 300ml of sterile saline solution 0.9%. | Other | Control Group |
Primary outcome
Hospitalization rate (safety and efficacy)
Time frame: Day 28
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.
SARS-CoV-2 viral load (safety and efficacy)
Time frame: Day 7
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.
16 secondary outcomes
COVID-19 WHO Clinical progression scale score (safety and efficacy)
Time frame: Day 60
COVID-19 symptoms severity score (safety and efficacy)
Time frame: Day 14
Resolution of symptoms (safety and efficacy)
Time frame: Day 28
Death rate (safety and efficacy)
Time frame: Day 60
Adverse events (AE) (safety and efficacy) Adverse events (AE) Adverse events (AE)
Time frame: Day 28
Ferritin (safety and efficacy)
Time frame: Baseline and Day 7
Prealbumin (safety and efficacy)
Time frame: Baseline and Day 7
Interleukin 6 (IL-6) (safety and efficacy)
Time frame: Baseline and Day 7
D-dimer (safety and efficacy)
Time frame: Baseline and Day 7
C reactive protein (CRP) (safety and efficacy)
Time frame: Baseline and Day 7
Leukocyte count (safety and efficacy)
Time frame: Baseline and Day 7
Lymphocyte count (safety and efficacy)
Time frame: Baseline and Day 7
Absolute neutralization titers against SARS-CoV-2 in plasma (safety and efficacy)
Time frame: Baseline and Day 7
Titers of neutralizing antibodies against SARS-CoV-2 in plasma (safety and efficacy)
Time frame: Baseline and Day 60
SARS-CoV-2 viral load of self-collected middle turbinate (MT) swab and saliva samples compared to nasopharyngeal swabs collected by a healthcare worker (safety and efficacy)
Time frame: Baseline and Day 7
Reduction of SARS-CoV-2 viral load (safety and efficacy)
Time frame: Baseline and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Derived from this study: PubMed 41080591Alemany 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.
- Derived from this study: PubMed 35546145Millat-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.
- Derived from this study: PubMed 35150610Alemany 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Convalescent anti-SARS-CoV-2 MBT plasma in people with SARS-CoV-2 Infection and Safety and Efficacy, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization rate (safety and efficacy) (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04621123, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.