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

Covid19 Clinical Trial

Official title:

Preemptive Use of Convalescent Plasma for High-risk Patients With SARS-CoV-2 Infection: Phase III-IV Non-controlled Non-randomised Swiss Multicentric Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04836260
• Other study ID #: 2020-02989
• Status: Recruiting
• Phase: Phase 3
• Start date: April 8, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Geneva
• Contact: Diem-Lan Vu Cantero, MD, PhD
• Phone: +41795535512
• Email: diem-lan.vu[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This is an open-label non-controlled, non-randomised interventional study. Study population consist in immunocompromised patients and older adults with or without co-morbidities. Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 or equivalent at maximum 3-7 days after diagnosis by RT-PCR or symptom onset or if having mild-moderate disease (WHO scale <4). Patients will be followed-up up to 28 days to assess progression to WHO scale 4 disease, and 28-days mortality and viral load kinetics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Immunocompromised patients defined as

1. Solid organ transplant =1 year before inclusion or treated for acute or chronic rejection episode or

2. Allogeneic stem cell transplant recipients =2 years before inclusion or treated for acute GvHD =grade 2 or chronic moderate-severe GvHD or

3. Active solid or haematological oncological disease with curative perspectives or

4. HIV infection with CD4<350 or

5. Hypogammaglobulinemia and other severe genetic immunological defect or

6. Auto-immune disease with biological immunosuppressive treatment* or

7. Other significant immunosuppressive condition such as IgG <6, treamtent with Rituximab or other biological lymphopenic treatment AND

• Age = 18 years old and
• 2 distinct ABO group determination and
• Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of = 7 days and days post symptom onset (DPOS) = 7 days at inclusion and/or
• 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)

2. 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)
• Chronic obstructive pulmonary disease stade GOLD =2
• Respiratory insufficiency due to any pneumopathy or neurologic disease.
• Cardiovascular disease as defined by either known coronary heart disease, history of ischemic or hemorrhagic stroke or cardiac insufficiency (ejection fraction <40%)
• Chronic kidney disease (GFR<60 ml/min) AND
• 2 distinct ABO group determination and
• Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of = 3 days and days post symptom onset (DPOS) = 3 days at inclusion or RT-PCR on a respiratory tract sample with CT value<20 or ascending kinetics at the time of perfusion and
• No additional oxygen requirement compared to baseline (WHO 8 ordinal scale < 4):

asymptomatic, mild or moderate disease and

• Compatible ABO donor with neutralizing antibodies (NTAB) =1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures) Exclusion criteria: Seroconversion at the time of inclusion
• 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

Related Conditions & MeSH terms

• Covid19
• Immuno-Deficiency
• Immunologic Deficiency Syndromes
• Old Age; Debility

Intervention

Drug:
• SARS-CoV-2 convalescent plasma
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.

Locations

Country	Name	City	State
Switzerland	Universitätsspital Basel	Basel
Switzerland	HFR-Fribourg Hôpital Cantonal	Fribourg
Switzerland	Geneva University Hospitals	Geneva
Switzerland	Ospedale Regionale di Lugano	Lugano

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Geneva	Hôpital Fribourgeois, Ospedale Regionale di Lugano, University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients that progress to WHO 8 ordinal scale = 4 (oxygen requirement)		21 days after plasma infusion
Other	Proportion of patients with cleared nasopharyngeal viral load	Will be evaluated if CT< 30 at 14 days	21 days after plasma infusion
Primary	Proportion of patient that progress to WHO 8 ordinal scale = 4 (oxygen requirement)		7 days after plasma infusion
Primary	Proportion of patient that progress to WHO 8 ordinal scale = 4 (oxygen requirement)		14 days after plasma infusion
Primary	Proportion of death		28 days after plasma infusion
Secondary	Proportion of patients with cleared nasopharyngeal viral load	Cleared viral load is defined as CT value =30	7 days after plasma infusion
Secondary	Proportion of patients with cleared nasopharyngeal viral load	Cleared viral load is defined as CT value =30	14 days after plasma infusion