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

Primary Purpose

SARS-CoV 2

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Hyperimmune plasma
Standard of care for SARS-CoV-2 infection
Sponsored by
Andalusian Network for Design and Translation of Advanced Therapies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Informed consent prior to performing procedures. the oral consent be accepted testified to prevent paper handling.
  2. Patient of both sexes, and ≥18 years.
  3. 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.

  4. 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:

  1. Requirement before randomization of mechanical ventilation (invasive or non-invasive).
  2. Any of the following analytical data before randomization: IL-6> 80 pg / mL, D-dimer> 10 times ULN, ferritin> 1000ng / mL.
  3. Participation in another clinical trial or experimental treatment for COVID-19.
  4. In the opinion of the clinical team, progression to death or mechanical ventilation is highly probable within 24 hours, regardless of treatment provision.
  5. Incompatibility or allergy to the administration of human plasma.
  6. Severe chronic kidney disease grade 4 or requiring dialysis (ie eGFR <30)
  7. 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

Sites / Locations

  • Hospital U. Jerez de la Frontera
  • Hospital U. Puerto Real
  • Hospital Costa del Sol
  • Hospital U. Torrecárdenas
  • Hospital U. Puerta del Mar
  • Hospital U. Virgen de las Nieves
  • Hospital U. San Cecilio
  • Hospital Juan Ramón Jiménez
  • Hospital Regional U. de Málaga
  • Hospital U. Virgen de la Victoria
  • Hospital Unversitario Virgen Macarena
  • Hospital Universitario Virgen del Rocío
  • Hospital U. Nuestra Señora de Valme
  • Hospital San Juan de Dios

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Comparator

Arm Description

Outcomes

Primary Outcome Measures

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).
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).
Efficacy: Death from any cause
Efficacy: Need for mechanical ventilation
Efficacy: Any of the following analytical data after 72h of randomization.
IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL.
Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level

Secondary Outcome Measures

Efficacy. Mortality on days 14 and 28.
Efficacy: Proportion of patients who required mechanical ventilation
Efficacy: Proportion of patients who develop analytical alterations.
IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL until the cure test.
Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.
Efficacy: PCR negative for SARS-CoV-2
Efficacy: Proportion of patients requiring treatment.
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.
Efficacy: Duration of hospitalization (days)
Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample
Virology and immunological variables: Total antibody quantification
Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.

Full Information

First Posted
April 22, 2020
Last Updated
April 5, 2022
Sponsor
Andalusian Network for Design and Translation of Advanced Therapies
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1. Study Identification

Unique Protocol Identification Number
NCT04366245
Brief Title
Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andalusian Network for Design and Translation of Advanced Therapies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Title
Comparator
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Hyperimmune plasma
Intervention Description
PLASMA OF CONVALESCENT COVID-19
Intervention Type
Drug
Intervention Name(s)
Standard of care for SARS-CoV-2 infection
Intervention Description
Standard of care for SARS-CoV-2 infection
Primary Outcome Measure Information:
Title
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).
Description
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
Title
Efficacy: Death from any cause
Time Frame
Day +21 after randomization
Title
Efficacy: Need for mechanical ventilation
Time Frame
Day +21 after randomization
Title
Efficacy: Any of the following analytical data after 72h of randomization.
Description
IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL.
Time Frame
Day +21 after randomization
Title
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 Outcome Measure Information:
Title
Efficacy. Mortality on days 14 and 28.
Time Frame
Days 14 and 28.
Title
Efficacy: Proportion of patients who required mechanical ventilation
Time Frame
Until day 28
Title
Efficacy: Proportion of patients who develop analytical alterations.
Description
IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL until the cure test.
Time Frame
Day +21 after randomization.
Title
Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.
Time Frame
Day +21 after randomization
Title
Efficacy: PCR negative for SARS-CoV-2
Time Frame
On days 7 and 21
Title
Efficacy: Proportion of patients requiring treatment.
Description
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.
Time Frame
Until day 21.
Title
Efficacy: Duration of hospitalization (days)
Time Frame
Until day 21.
Title
Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample
Time Frame
At baseline and on day 21
Title
Virology and immunological variables: Total antibody quantification
Time Frame
At baseline and on days 3, 7 and 21
Title
Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.
Time Frame
Before infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital U. Jerez de la Frontera
City
Jerez de la Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital U. Puerto Real
City
Puerto Real
State/Province
Cádiz
ZIP/Postal Code
11510
Country
Spain
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Málaga
ZIP/Postal Code
29603
Country
Spain
Facility Name
Hospital U. Torrecárdenas
City
Almería
ZIP/Postal Code
04009
Country
Spain
Facility Name
Hospital U. Puerta del Mar
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital U. Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital U. San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital Regional U. de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital U. Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Unversitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital U. Nuestra Señora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital San Juan de Dios
City
Sevilla
ZIP/Postal Code
41930
Country
Spain

12. IPD Sharing Statement

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

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