Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19

NCT04836260 | Unknown Phase 3

• 1 other identifier: 2020-02989
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

Convalescent plasma therapy has been recognized as safe and plasma transfusion is routinely used in clinical practice. A recent study showed that early administration of convalescent plasma can decrease the risk of complications in specific high-risk population. The aim of the present study is to offer convalescent plasma therapy to immunocompromised patients and older adults in the early phase of a SARS-Cov-2 infection in order to accelerate viral clearance and prevent complication

Conditions

Covid19; Immuno-Deficiency; Old Age; Debility

Keywords

SARS-CoV-2; Convalescent plasma

Outcome Measures

Primary Outcomes (3)

• Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)

  7 days after plasma infusion

• Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)

  14 days after plasma infusion

• Proportion of death

  28 days after plasma infusion

Secondary Outcomes (2)

• Proportion of patients with cleared nasopharyngeal viral load

  7 days after plasma infusion

• Proportion of patients with cleared nasopharyngeal viral load

  14 days after plasma infusion

Other Outcomes (2)

• Proportion of patients that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)

  21 days after plasma infusion

• Proportion of patients with cleared nasopharyngeal viral load

  21 days after plasma infusion

Interventions

SARS-CoV-2 convalescent plasma DRUG

Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 at maximum 3-7 days after diagnosis by RT-PCR or symptom onset. A second unit of plasma from a different donor can be proposed 24h after the first unit if immunocompromised and/or the patient received less than 3-5ml/kg of plasma volume. Additional units can be exceptionnally infused, at the investigator discretion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Immunocompromised patients defined as
• Active solid or haematological oncological disease with curative perspectives or
• HIV infection with CD4\<350 or
• Hypogammaglobulinemia and other severe genetic immunological defect or
• Auto-immune disease with biological immunosuppressive treatment\* or
• Other significant immunosuppressive condition such as IgG \<6, treamtent with Rituximab or other biological lymphopenic treatment AND
• Age ≥ 18 years old and
• distinct ABO group determination and
• No oxygen requirement (WHO 8 ordinal scale \< 4): asymptomatic, mild or moderate disease, or O2 saturation ≥ 90% at room temperature and
• Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures)
• RT-PCR on a respiratory tract sample with CT value\<20 or ascending kinetics at the time of infusion (highly suggested but not necessary)
• Older adults defined as Age ≥ 75 years old or ≥ 65 years old with at least one co-existing condition
• Arterial hypertension under pharmacological treatment
• Diabetes in treatment
• Obesity (BMI ≥ 30 kg/m2)

You may not qualify if:

• Palliative care
• No signed informed consent
• History of previous transfusion-related Grade 3 adverse event according to Swissmedic definitions
• Disseminated intravascular coagulopathy (depending on specialist evaluation)
• Uncontrolled acute hypervolemia

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University Hospital, Basel, Switzerland: collaborator
• Ospedale Regionale di Lugano: collaborator
• Hôpital Fribourgeois: collaborator

Study Sites (4)

Universitätsspital Basel

Basel, 4031, Switzerland

RECRUITING

HFR-Fribourg Hôpital Cantonal

Fribourg, 1708, Switzerland

RECRUITING

Geneva University Hospitals

Geneva, 1205, Switzerland

RECRUITING

Ospedale Regionale di Lugano

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

COVID-19; Frailty

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Laurent Kaiser, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

• Enos Bernasconi, MD

  Ospedale Regionale di Lugano

  PRINCIPAL INVESTIGATOR

• Véronique Erard, MD

  HFR-Fribourg Hôpital Cantonal

  PRINCIPAL INVESTIGATOR

• Maja Weisser, MD

  Klinik Infektiologie & Spitalhygiene

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diem-Lan Vu Cantero, MD, PhD

CONTACT

+41795535512; diem-lan.vu@hcuge.ch

Nina Khanna, MD

CONTACT

+41613287325; nina.khanna@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: open-label non-controlled, non-randomised interventional study

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: April 8, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

CH (4)