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Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19 (COVIC-19)

Primary Purpose

COVID-19

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Current standard of care and COVID-19 convalescent and vaccinated plasma

Current standard of care

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Cohort 1: Elderly and high COVID-age population:

Inclusion criteria:

SARS-CoV-2 RNA detected in a specimen, ≤ 7 days after onset of symptoms
Symptoms of COVID-19 (so including but not limited to: fever; cough; breathlessness; chest pain; wheeze; sore throat; haemoptysis; runny nose; fatigue; muscle or joint pain; confusion; headache; seizures; nausea; vomiting; diarrhoea; abdominal pain; poor appetite; skin ulcers or rash; ear pain; conjunctivitis; anosmia; bleeding; lymphadenopathy. The attending clinician will determine if symptoms are consistent with COVID-19.
Clinical status not requiring admission to hospital for COVID-19 disease and oxygen support
Ability to transfuse (per randomisation) within 7 days after onset of symptoms
Men or women, 70 years or older OR
under 70 years with significant comorbidities (arterial hypertension, diabetes, obesity, asthma or other chronic pulmonary disease, cardiovascular disease, cerebrovascular disease, chronic kidney disease / dialysis, hemoglobinopathies, liver disease, chronic neurological disease, rheumatoid arthritis, lupus or psoriasis) resulting in a 'COVID-age' of 70 years or more according to the ALAMA risk calculator https://alama.org.uk/covid-19-medical-risk-assessment/

Exclusion Criteria:

Age < 18 years (France and Germany only)
Prior or concurrent treatment for COVID-19 (unless listed as authorized)
History of COVID-19 disease in the last 90 days prior to enrollment
Prior anti-SARS-CoV-2 immunization
Contraindication to receiving CCP including previous history of transfusion-related acute lung injury (TRALI) or moderate or severe allergic reaction to blood components
Known participant objection to receiving plasma products
Primary or acquired immune deficiency listed below (see cohort 2)
Refusal to participate expressed by patient or legally authorised representative
Pregnancy

Cohort 2: High-risk immunocompromised population

Inclusion criteria:

SARS-CoV-2 RNA detected in a specimen, ≤ 7 days after onset of symptoms
Symptoms of COVID-19 (so including but not limited to: fever; cough; breathlessness; chest pain; wheeze; sore throat; haemoptysis; runny nose; fatigue; muscle or joint pain; confusion; headache; seizures; nausea; vomiting; diarrhoea; abdominal pain; poor appetite; skin ulcers or rash; ear pain; conjunctivitis; anosmia; bleeding; lymphadenopathy. The attending clinician will determine if symptoms are consistent with COVID-19.
Clinical status not requiring admission to hospital for COVID-19 disease and oxygen support
Ability to transfuse (per randomisation) within 7 days after onset of symptoms
Male or female with extremely high risk including:
a. Patients with at least one of the following acquired immune deficiencies
i. Lymphoid malignancies treated within the last 12 months ii. Lymphoid malignancies with persistent hypogammaglobulinaemia (IgG < 5g/L) iii. Myeloid malignancies treated by chemotherapy within the last 12 months iv. Myeloid malignancies treated by anti-BCL-2 drugs within the last 12 months v. Myeloid malignancies associated with prolonged neutropenia (≥ 6 weeks) vi. Solid tumour undergoing treatment with chemotherapy (until 3 months after completion of the last chemotherapy cycle) vii. Allogenic hematopoietic stem cell transplantation within the last 12 months or anytime if on-going treatment for chronic GVHD viii. Organ transplantation ix. Anti-B (CD20/CD19) MoAb and/or mycophenolate mofetil treatment within the last 12 months x. Anti-CD19/CD20 CAR-T cell treatment xi. ATG or alemtuzumab treatment within the last 6 months xii. AIDS

OR b. Patients with primary lymphoid immune deficiencies. i. B cell deficiencies (such as Bruton agammaglobulinemia) ii. T cell deficiencies (such as Wiskott Aldrich disease) iii. Combined deficiencies (such as Common variable immunodeficiency).

OR c. Patients without detectable seroconversion ≥ 3 weeks after complete vaccination schedule with an approved vaccine.

Exclusion Criteria:

Age < 18 years (France and Germany only)
Prior or concurrent treatment for COVID-19 (dexamethasone, anti-IL-6/IL6R, remdesivir) except for prophylactic administration of anti-SARS-CoV-2 monoclonal antibodies (pre or post exposure) and authorized specific treatment
History of COVID-19 disease in the last 90 days prior to enrollment
Contraindication to receiving CCP including previous history of transfusion-related acute lung injury (TRALI) or moderate or severe allergic reaction to blood components
Known participant objection to receiving plasma products
Refusal to participate expressed by patient or legally authorised representative
Pregnancy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Current standard of care

Current standard of care and convalescent plasma

Arm Description

Standard of care therapy may include anti-SARS-CoV-2 specific medication such as, but not limited to: Casirivimab Casirivimab / Imdevimab (REGN-COV2 or Ronapreve) Imdevimab Sotrovimab (Xevudy) Tixagevimab / Cilgavimab (Evusheld) Molnupiravir (MK-4482) Nirmatrevlir / Ritonavir (Paxlovid) Remdesivir Centres should ensure that medications used as standard of care are used similarly for patients in both treatment arms.

Current standard of care and the infusion of two plasma units collected from two different COVID-19 convalescent patients.

Outcomes

Primary Outcome Measures

Proportion of participants with hospitalisation with progressive COVID-19 symptoms or death

Proportion of participants with (1) at least one overnight stay in hospital for progressive COVID-19 symptoms or (2) who died

Secondary Outcome Measures

Proportion of participants with hospitalisation for progressive COVID-19 symptoms or death

Proportion of patients with hospitalisation for progressive COVID-19 symptoms requiring O2 support*, or death *O2 support: requirement based on O2 saturation level on room air <=93% or respiration rate >30

All-cause mortality

Proportion of patients with supplemental oxygen

Proportion of patients with non-invasive ventilation

Proportion of patients with intubation and mechanical ventilation

Change in 10-point WHO Clinical Progression Scale score

The 10-point WHO clinical progression scale ranges from 0 to 10 (0: uninfected; 10: death)

Duration of hospital admission censored at 28 days

Proportion of patients with admission to ITU

Duration of ITU admission censored at 28 days

Proportion of patients with long COVID-19 symptoms and time to recovery

Health-related quality of life assessed by EQ-5D quality of life index

EQ-5D is one of the most widely used Health-related quality of life measure. EQ-5D questionnaires have 5 dimensions: Mobility, Human Autonomy, Current Activities, Pain & Discomfort, "Anxiety & Depression, and all dimensions are described by 5 levels corresponding to patient response choices. A quality of life index ranging from less than 0 (worse than death) to 1 (full health) is derived from the answers to the questionnaires.

Number of Serious Adverse Events

Grade 3/4 adverse events and AE unexpected for their nature, onset, evolution, severity or frequency

Number of Participants with arterial and venous thromboembolic events

Full Information

NCT ID

NCT05271929

First Posted

March 3, 2022

Last Updated

November 10, 2022

Sponsor

Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

Collaborators

NHS Blood and Transplant

1. Study Identification

Unique Protocol Identification Number

NCT05271929

Brief Title

Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19

Acronym

COVIC-19

Official Title

A Randomised Open-Label Trial of Early, Very High-Titre Convalescent Plasma Therapy in Clinically Vulnerable Individuals With Mild COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

March 10, 2024 (Anticipated)

Study Completion Date

September 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

Collaborators

NHS Blood and Transplant

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Research Question: Does convalescent plasma (CCP) collected from donors who have recovered from COVID-19 and who have a very high titre of anti-SARS-CoV-2 antibodies reduce the risk of hospitalisation (for COVID-19) or death in patients with early symptoms of acute COVID-19 who are vulnerable to this disease compared to standard of care? Study product: Very high antibody titre COVID-19 convalescent plasma collected more than 15 days after end of symptoms in COVID-19 patients who also had received at least one dose of a SARS-CoV-2 vaccine. Methodology: Multicentre, randomised, open-label, adaptive superiority trial: COVID-19 very high neutralizing Ab titre convalescent plasma vs standard care in 2 cohorts of vulnerable patients (cohort 1: elderly (≥ 70 years) and younger with comorbidities, cohort 2: immunosuppressed patients). Study phase: Phase 3 Intervention: Two units of high antibody titre COVID-19 convalescent plasma to individuals randomised to the intervention group, 2 units from 2 different donors, preferably transfused on the same day. Plasma provided by convalescent vaccinated donors with a minimum antibody titre of 1:640 against delta variant (B1.617.2) or antibody concentration >=4.000 BAU/ml in the QuantiVac anti-SARS-CoV-2 IgG ELISA or >=20.000 U/ml in the Elecsys anti-SARS-CoV-2 CLIA Randomisation: 1:1 (standard of care + convalescent plasma vs. standard of care) stratified by centre (cohorts 1 and 2)

Detailed Description

COVIC-19 is a multicentre international, randomised, open-label adaptive superiority phase III trial to evaluate the efficacy and safety of COVID-19 convalescent plasma in the treatment of COVID-19. It is conducted in a harmonized approach in different countries in Europe. The study is randomizing adult COVID-19 patients to one of two arms (1:1 ratio): standard of care or standard of care and very high neutralizing Ab titre convalescent plasma. Randomization will be stratified by centre and by patient cohort. The control group will receive 'standard care' therapy. Neither blinding nor placebo will be used to avoid unnecessary intravenous access. Standard of care therapy may include anti-SARS-CoV-2 specific medication listed as authorized in the protocol. Centres should ensure that medications used as standard of care are used similarly for patients in both treatment arms. Participating patients will be included in 2 cohorts of vulnerable patients (cohort 1: elderly (≥ 70 years) and younger with comorbidities (cohort 1: < 70 with comorbidities), cohort 2: immunosuppressed patients). All subjects will undergo a series of efficacy and safety assessments, including laboratory assays. Subjects will be assessed at baseline, and at Days 3, 14, 28, 90 and 180. Nasopharyngeal swabs (NP) or lower respiratory tract samples will be obtained at D1 (pre-treatment), and at D3, D14 and D28 (and monthly in case of positivity until of clearance) for cohort 2. Blood samples will be obtained at D1, D14 and D28 and on the day of hospitalization (if applicable). The trial is sponsored by the University Hospital of Besançon in France, the German Red Cross in Germany and the NHSBT in the United Kingdom.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

680 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Current standard of care

Arm Type

Active Comparator

Arm Description

Arm Title

Current standard of care and convalescent plasma

Arm Type

Experimental

Arm Description

Current standard of care and the infusion of two plasma units collected from two different COVID-19 convalescent patients.

Intervention Type

Biological

Intervention Name(s)

Current standard of care and COVID-19 convalescent and vaccinated plasma

Intervention Description

ABO compatible convalescent plasma infused intravenously on study day 1 (as soon as possible after randomisation) and the second on day 1 or day 2. Plasma obtained by apheresis from donors who have recovered from COVID-19 infection (at least 14 days after recovery) and have been vaccinated (at least 3 weeks after first dose of vaccine). A combination of both a SARS-CoV-infection and a SARS-CoV-2 vaccination of the donor is required - irrespective of the sequence of infection and vaccination. As far as the availability of CCP units allows, the two plasma units should have been donated by two different convalescents.

Intervention Type

Other

Intervention Name(s)

Current standard of care

Intervention Description

Primary Outcome Measure Information:

Title

Proportion of participants with hospitalisation with progressive COVID-19 symptoms or death

Description

Proportion of participants with (1) at least one overnight stay in hospital for progressive COVID-19 symptoms or (2) who died

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

Proportion of participants with hospitalisation for progressive COVID-19 symptoms or death

Time Frame

Day 14

Title

Time Frame

Day 14 and Day 28

Title

All-cause mortality

Time Frame

Day 28, 90, 180

Title

Proportion of patients with supplemental oxygen

Time Frame

Day 14, 28

Title

Proportion of patients with non-invasive ventilation

Time Frame

Day 14, 28

Title

Proportion of patients with intubation and mechanical ventilation

Time Frame

Day 14, 28

Title

Change in 10-point WHO Clinical Progression Scale score

Description

The 10-point WHO clinical progression scale ranges from 0 to 10 (0: uninfected; 10: death)

Time Frame

Day 14, 28

Title

Duration of hospital admission censored at 28 days

Time Frame

Day 28

Title

Proportion of patients with admission to ITU

Time Frame

Day 14, 28

Title

Duration of ITU admission censored at 28 days

Time Frame

Day 28

Title

Proportion of patients with long COVID-19 symptoms and time to recovery

Time Frame

Day 28, 180

Title

Health-related quality of life assessed by EQ-5D quality of life index

Description

Time Frame

Day 28, 180

Title

Number of Serious Adverse Events

Description

Grade 3/4 adverse events and AE unexpected for their nature, onset, evolution, severity or frequency

Time Frame

72 hours

Title

Number of Participants with arterial and venous thromboembolic events

Time Frame

Day 28, 90, 180

Other Pre-specified Outcome Measures:

Title

Change in SARS-CoV-2 RNA level

Description

Polymerase chain reaction, Cycle Threshold value in oral or nose/throat swab samples at days 3, 14, 28 and 180 after randomisation

Time Frame

Day 3, 14, 28, 180

Title

Change in anti-SARS-CoV-2 spike antibody levels in blood

Time Frame

Day 14, 28

Title

SARS-CoV-2 whole-genome sequence analysis

Time Frame

Day 1, 28

Title

Proportion and clinical characteristics of patients with cultivable virus

Time Frame

Day 28, 180

Title

Virus sequence variation and cultivability over time, overall and in individuals receiving vs not receiving CCP

Time Frame

Day 1, 28

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Cohort 1: Elderly and high COVID-age population: Inclusion criteria: SARS-CoV-2 RNA detected in a specimen, ≤ 7 days after onset of symptoms Symptoms of COVID-19 (so including but not limited to: fever; cough; breathlessness; chest pain; wheeze; sore throat; haemoptysis; runny nose; fatigue; muscle or joint pain; confusion; headache; seizures; nausea; vomiting; diarrhoea; abdominal pain; poor appetite; skin ulcers or rash; ear pain; conjunctivitis; anosmia; bleeding; lymphadenopathy. The attending clinician will determine if symptoms are consistent with COVID-19. Clinical status not requiring admission to hospital for COVID-19 disease and oxygen support Ability to transfuse (per randomisation) within 7 days after onset of symptoms Men or women, 70 years or older OR under 70 years with significant comorbidities (arterial hypertension, diabetes, obesity, asthma or other chronic pulmonary disease, cardiovascular disease, cerebrovascular disease, chronic kidney disease / dialysis, hemoglobinopathies, liver disease, chronic neurological disease, rheumatoid arthritis, lupus or psoriasis) resulting in a 'COVID-age' of 70 years or more according to the ALAMA risk calculator https://alama.org.uk/covid-19-medical-risk-assessment/ Exclusion Criteria: Age < 18 years (France and Germany only) Prior or concurrent treatment for COVID-19 (unless listed as authorized) History of COVID-19 disease in the last 90 days prior to enrollment Prior anti-SARS-CoV-2 immunization Contraindication to receiving CCP including previous history of transfusion-related acute lung injury (TRALI) or moderate or severe allergic reaction to blood components Known participant objection to receiving plasma products Primary or acquired immune deficiency listed below (see cohort 2) Refusal to participate expressed by patient or legally authorised representative Pregnancy Cohort 2: High-risk immunocompromised population Inclusion criteria: SARS-CoV-2 RNA detected in a specimen, ≤ 7 days after onset of symptoms Symptoms of COVID-19 (so including but not limited to: fever; cough; breathlessness; chest pain; wheeze; sore throat; haemoptysis; runny nose; fatigue; muscle or joint pain; confusion; headache; seizures; nausea; vomiting; diarrhoea; abdominal pain; poor appetite; skin ulcers or rash; ear pain; conjunctivitis; anosmia; bleeding; lymphadenopathy. The attending clinician will determine if symptoms are consistent with COVID-19. Clinical status not requiring admission to hospital for COVID-19 disease and oxygen support Ability to transfuse (per randomisation) within 7 days after onset of symptoms Male or female with extremely high risk including: a. Patients with at least one of the following acquired immune deficiencies i. Lymphoid malignancies treated within the last 12 months ii. Lymphoid malignancies with persistent hypogammaglobulinaemia (IgG < 5g/L) iii. Myeloid malignancies treated by chemotherapy within the last 12 months iv. Myeloid malignancies treated by anti-BCL-2 drugs within the last 12 months v. Myeloid malignancies associated with prolonged neutropenia (≥ 6 weeks) vi. Solid tumour undergoing treatment with chemotherapy (until 3 months after completion of the last chemotherapy cycle) vii. Allogenic hematopoietic stem cell transplantation within the last 12 months or anytime if on-going treatment for chronic GVHD viii. Organ transplantation ix. Anti-B (CD20/CD19) MoAb and/or mycophenolate mofetil treatment within the last 12 months x. Anti-CD19/CD20 CAR-T cell treatment xi. ATG or alemtuzumab treatment within the last 6 months xii. AIDS OR b. Patients with primary lymphoid immune deficiencies. i. B cell deficiencies (such as Bruton agammaglobulinemia) ii. T cell deficiencies (such as Wiskott Aldrich disease) iii. Combined deficiencies (such as Common variable immunodeficiency). OR c. Patients without detectable seroconversion ≥ 3 weeks after complete vaccination schedule with an approved vaccine. Exclusion Criteria: Age < 18 years (France and Germany only) Prior or concurrent treatment for COVID-19 (dexamethasone, anti-IL-6/IL6R, remdesivir) except for prophylactic administration of anti-SARS-CoV-2 monoclonal antibodies (pre or post exposure) and authorized specific treatment History of COVID-19 disease in the last 90 days prior to enrollment Contraindication to receiving CCP including previous history of transfusion-related acute lung injury (TRALI) or moderate or severe allergic reaction to blood components Known participant objection to receiving plasma products Refusal to participate expressed by patient or legally authorised representative Pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eric Toussirot, MD, PhD

Phone

+333 81 21 83 96‬

etoussirot@chu-besancon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre Tiberghien, MD, PhD

Organizational Affiliation

Etablissement Français du Sang, La Plaine Saint-Denis, France

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Eric Toussirot, MD, PhD

Organizational Affiliation

Rheumatology department, CHU Besançon, France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hubert Schrezenmeier, MD, PhD

Organizational Affiliation

German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lise Estcourt, MD, PhD

Organizational Affiliation

NHS Blood and Transplant, Oxford, United Kingdom

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David Roberts, MD, PhD

Organizational Affiliation

NHS Blood and Transplant, Oxford, United Kingdom

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bart Rijnders, MD, PhD

Organizational Affiliation

Erasmus Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Besançon

City

Besançon

ZIP/Postal Code

25000

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric Toussirot, MD, PhD

Facility Name

Stauferklinikum Schwäbisch Gmünd

City

Mutlangen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

73527

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Holger Herbart, Prof. Dr.

Facility Name

Klinikum Stuttgart

City

Stuttgart

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

70174

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gregor Paul, Prof Dr. med

Facility Name

Diakonie-Klinikum Stuttgart

City

Stuttgart

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

70176

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jochen Greiner, Prof Dr med

Facility Name

Uniklinikum Tübingen

City

Tübingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

72076

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tamam Bakchoul, Prof Dr med

Facility Name

Institut für Klinische Transfusionsmedizin (IKT)

City

Ulm

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

89081

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hubert Schrezenmeier, Prof Dr med.

Facility Name

Uniklinikum Ulm

City

Ulm

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

89081

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beate Grüner, Prof Dr med.

Facility Name

Universitätsklinikum Brandenburg

City

Brandenburg an der Havel

State/Province

Brandenburg

ZIP/Postal Code

14770

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Markus Deckert, Prof Dr med

Facility Name

Universitätsklinikum Frankfurt

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Vehreschild, Prof. Dr. med.

Facility Name

Elblandkliniken Riesa

City

Riesa

State/Province

Sachsen

ZIP/Postal Code

01589

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joerg Schubert, Prof Dr med

Facility Name

Charité Medizinische Klinik IV

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabian Halleck, Dr. med.

Facility Name

Klinikum Chemnitz gGmbH

City

Chemnitz

ZIP/Postal Code

09116

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathias Hänel, PD Dr.

Facility Name

Erasmus Medical Center

City

Rotterdam

ZIP/Postal Code

3000CA

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bart Rijnders, MD, PhD

Facility Name

NHS Blood and Transplant

City

Oxford

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lise Estcourt, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19

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Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19 (COVIC-19)

COVID-19

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial