CoV-PlasGal: Passive Immunotherapy In Patients With SARS CoV-2
Study Details
Study Description
Brief Summary
Plasma from convalescent individuals (convalescent plasma, CP) has been used for more than a hundred years for the treatment of infectious diseases. Among patients with COVID-19, it has been used first, in patients with severe infection. Although it is a safe treatment, it has not been possible to demonstrate a reduction in mortality in cases of acute respiratory distress syndrome.
The objective of the clinical trial is to evaluate the efficacy and safety of the early use (less than 5 days of symptoms) of CP in patients infected with SARS-CoV-2 with risk factors for severe disease.
The primary efficacy endpoint was the proportion of patients requiring oxygen therapy to maintain saturation >93% on day 14. Secondary objectives included, evaluation of the safety of the treatment, measured as the appearance of some adverse event related to the CP infusion; the evolution of COVID-19 symptoms and WHO progression scale status at day 14 and 28 after inclusion; the need for hospitalization due to progression of COVID-19. COVID-19 progression was considered as worsening of respiratory symptoms requiring oxygen therapy at some point. Finally, death from any cause was evaluated at 28 days, after inclusion in the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Convalescent plasma
|
Biological: Convalescent plasma
Admistration of one unit of convalescent plasma
|
| No Intervention: Conventional treatment
|
Outcome Measures
Primary Outcome Measures
- Requirement for oxygen therapy to maintain saturation >93% [Day 14]
Proportion of patients that need oxygen to achieve a saturation >93%
Secondary Outcome Measures
- Safety of the treatment with CP [Day 1]
Safety of CP treatment was evaluated by the appearance of any adverse event related to the infusion
- Evolution of COVID-19 symptoms [Day 14 and 28]
Proportion of patients with 1+2 WHO progression scale. This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity. = Not hospitalized without limitation in activity (no symptoms) = Not hospitalized with limitation in activity (continued symptoms) = Hospitalized not on supplemental oxygen = Hospitalized on supplemental oxygen by mask or nasal prongs = Hospitalized on non-invasive ventilation or high flow nasal cannula = Hospitalized, intubated and mechanically ventilated = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy) = Death
- Requirement for hospitalization due to worsening of symptoms [Until day 28]
Worsening of symptoms was evaluated using the WHO progression scale = Not hospitalized without limitation in activity (no symptoms) = Not hospitalized with limitation in activity (continued symptoms) = Hospitalized not on supplemental oxygen = Hospitalized on supplemental oxygen by mask or nasal prongs = Hospitalized on non-invasive ventilation or high flow nasal cannula = Hospitalized, intubated and mechanically ventilated = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy) = Death
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients with SARS-CoV-2 infection, confirmed by any validated microbiological technique, and with one or more symptoms associated with COVID-19 with ≤5 days of evolution and with an oxygen saturation ≥93% breathing room air.
In addition, the patients had to present some risk factor for severe disease:
-
Chronic heart failure (NYHA ≥ 2)
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Arterial hypertension under pharmacological treatment
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Chronic lung disease: COPD (bronchitis, emphysema or chronic obstruction) with dyspnoea at least on moderate exertion, or moderate-severe asthma (that required inhaled corticosteroids to control symptoms or had received systemic corticosteroids during the last year due to decompensation)
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Chronic renal failure (glomerular filtration rate <60 ml/min/1.73 m², by CKD- ILD)
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Diabetes mellitus requiring pharmacological treatment or obesity grade ≥ I (BMI ≥30 Kg/m2).
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Patients ≥65 years were included, regardless of other risk factors.
Exclusion Criteria:
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Duration of symptoms >5 days
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Dyspnoea at rest
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Need for supplemental oxygen to maintain O2 saturation >93%
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Solid neoplastic or haematologic disease (except skin cancer) with active treatment in the last 3 months before the onset of symptoms
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Patients under chronic corticosteroid treatment (equivalent to prednisone 10 mg/d for at least 28 days) or immunosuppressive treatment
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Decompensated liver cirrhosis
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Participation in another clinical trial
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History of hypersensitivity to haematological derivatives
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Pregnancy or lactation,
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AST/ALT >5 times the upper limit of normal or at baseline in patients with chronic liver disease
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Any condition that in the opinion of the investigator limits participation in the study.
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Patients who had received monoclonal antibodies against SARS-CoV-2
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Álvaro Cunqueiro | Vigo | Spain | 36211 |
Sponsors and Collaborators
- Fundacin Biomedica Galicia Sur
- Health Knowledge Agency
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CoV-PlasGal