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Completed

NCT Number: NCT05578391

Passive Immunotherapy In Patients With SARS CoV-2

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Álvaro Cunqueiro

Vigo, 36211, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • Arterial hypertension under pharmacological treatment
  • 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)
  • Chronic renal failure (glomerular filtration rate <60 ml/min/1.73 m², by CKD- ILD)
  • Diabetes mellitus requiring pharmacological treatment or obesity grade ≥ I (BMI ≥30 Kg/m2).
  • Patients ≥65 years were included, regardless of other risk factors.

Exclusion criteria

  • Duration of symptoms >5 days
  • Dyspnoea at rest
  • Need for supplemental oxygen to maintain O2 saturation >93%
  • Solid neoplastic or haematologic disease (except skin cancer) with active treatment in the last 3 months before the onset of symptoms
  • Patients under chronic corticosteroid treatment (equivalent to prednisone 10 mg/d for at least 28 days) or immunosuppressive treatment
  • Decompensated liver cirrhosis
  • Participation in another clinical trial
  • History of hypersensitivity to haematological derivatives
  • Pregnancy or lactation,
  • AST/ALT >5 times the upper limit of normal or at baseline in patients with chronic liver disease
  • Any condition that in the opinion of the investigator limits participation in the study.
  • Patients who had received monoclonal antibodies against SARS-CoV-2

Treatment and study plan

Convalescent Plasma

Biological

Admistration of one unit of convalescent plasma

Primary outcomes

  1. Requirement for oxygen therapy to maintain saturation >93%

    Time frame: Day 14

    Proportion of patients that need oxygen to achieve a saturation >93%

Secondary outcomes

  1. Safety of the treatment with CP

    Time frame: Day 1

    Safety of CP treatment was evaluated by the appearance of any adverse event related to the infusion

  2. Evolution of COVID-19 symptoms

    Time frame: 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
  3. Requirement for hospitalization due to worsening of symptoms

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fundacin Biomedica Galicia Sur

Other

Collaborators

  • Health Knowledge Agency

Registry information

Official study title

PHASE II Clinical Trial Randomized And Controlled To Assess Need Of Oxygen On Day 14 After Administration Of Passive Immunotherapy In Patients Infected By SARS-CoV-2 With Risks Factors For Severe Disease

Acronym: CoV-PlasGal

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 13, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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