Skip to main content
OpenTrials
Completed

NCT Number: NCT04366245

Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection

Phase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19 infection.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital U. Jerez de la Frontera, Jerez de la Frontera, Cádiz, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent prior to performing procedures. the oral consent be accepted testified to prevent paper handling.
  • Patient of both sexes, and ≥18 years.
  • SARS-CoV-2 infection determined by PCR in a sample of naso-oropharyngeal exudate or other respiratory specimen or determination of specific positive IgM antibodies, in <72 hours before randomization.
  • Patients requiring hospitalization for pneumonia COVID-19 without need until randomization of mechanical ventilation (invasive or non-invasive), and at least one of the following:
  • O2 saturation ≤ 94% in ambient air, or PaO2 / FiO2 ≤ 300 mm Hg.
  • Age> 65 years.
  • Presence of: high blood pressure, chronic heart failure, chronic obstructive pulmonary disease, liver cirrhosis, or other chronic pulmonary and cardiovascular diseases, diabetes, or obesity

Exclusion criteria

  • Requirement before randomization of mechanical ventilation (invasive or non-invasive).
  • Any of the following analytical data before randomization: IL-6> 80 pg / mL, D-dimer> 10 times ULN, ferritin> 1000ng / mL.
  • Participation in another clinical trial or experimental treatment for COVID-19.
  • In the opinion of the clinical team, progression to death or mechanical ventilation is highly probable within 24 hours, regardless of treatment provision.
  • Incompatibility or allergy to the administration of human plasma.
  • Severe chronic kidney disease grade 4 or requiring dialysis (ie eGFR <30)
  • Pregnant, lactating, or fertile women who are not using an effective method of contraception. It is considered a woman of childbearing age all women from 18 years and up to a year after the last menstrual period in the case of menopausal women

Treatment and study plan

Hyperimmune plasma

Biological

PLASMA OF CONVALESCENT COVID-19

Standard of care for SARS-CoV-2 infection

Drug

Standard of care for SARS-CoV-2 infection

Primary outcomes

  1. Safety: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).

    Time frame: 30 days after enrollment

    Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).

  2. Efficacy: Death from any cause

    Time frame: Day +21 after randomization

  3. Efficacy: Need for mechanical ventilation

    Time frame: Day +21 after randomization

  4. Efficacy: Any of the following analytical data after 72h of randomization.

    Time frame: Day +21 after randomization

    IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL.

  5. Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level

    Time frame: Day +21 after randomization

Secondary outcomes

  1. Efficacy. Mortality on days 14 and 28.

    Time frame: Days 14 and 28.

  2. Efficacy: Proportion of patients who required mechanical ventilation

    Time frame: Until day 28

  3. Efficacy: Proportion of patients who develop analytical alterations.

    Time frame: Day +21 after randomization.

    IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL until the cure test.

  4. Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.

    Time frame: Day +21 after randomization

  5. Efficacy: PCR negative for SARS-CoV-2

    Time frame: On days 7 and 21

  6. Efficacy: Proportion of patients requiring treatment.

    Time frame: Until day 21.

    Proportion of patients requiring treatment with Tocilizumab Sarilumab, Anakimra or other IL-6 or IL-1 antagonists, or corticosteroids at doses of methylprednisolone greater than 2 mg / Kg / day (or equivalent) and / or any investigational medication.

  7. Efficacy: Duration of hospitalization (days)

    Time frame: Until day 21.

  8. Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample

    Time frame: At baseline and on day 21

  9. Virology and immunological variables: Total antibody quantification

    Time frame: At baseline and on days 3, 7 and 21

  10. Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.

    Time frame: Before infusion

Sponsors and collaborators

Lead sponsor

Andalusian Network for Design and Translation of Advanced Therapies

Other

Registry information

Official study title

Phase I / II Multicentre, Randomized and Controlled Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2020
Registry last updated
Apr 6, 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.

Published trials that share one or more normalized conditions with this study.