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

Sponsor
Andalusian Network for Design and Translation of Advanced Therapies (Other)
Overall Status
Completed
CT.gov ID
NCT04366245
Collaborator
(none)
72
14
2
8.2
5.1
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Hyperimmune plasma
  • Drug: Standard of care for SARS-CoV-2 infection
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 23, 2020
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Dec 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Biological: Hyperimmune plasma
PLASMA OF CONVALESCENT COVID-19

Active Comparator: Comparator

Drug: Standard of care for SARS-CoV-2 infection
Standard of care for SARS-CoV-2 infection

Outcome Measures

Primary Outcome Measures

  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). [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 [Day +21 after randomization]

  3. Efficacy: Need for mechanical ventilation [Day +21 after randomization]

  4. Efficacy: Any of the following analytical data after 72h of randomization. [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 [Day +21 after randomization]

Secondary Outcome Measures

  1. Efficacy. Mortality on days 14 and 28. [Days 14 and 28.]

  2. Efficacy: Proportion of patients who required mechanical ventilation [Until day 28]

  3. Efficacy: Proportion of patients who develop analytical alterations. [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. [Day +21 after randomization]

  5. Efficacy: PCR negative for SARS-CoV-2 [On days 7 and 21]

  6. Efficacy: Proportion of patients requiring treatment. [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) [Until day 21.]

  8. Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample [At baseline and on day 21]

  9. Virology and immunological variables: Total antibody quantification [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. [Before infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital U. Jerez de la Frontera Jerez de la Frontera Cádiz Spain 11407
2 Hospital U. Puerto Real Puerto Real Cádiz Spain 11510
3 Hospital Costa del Sol Marbella Málaga Spain 29603
4 Hospital U. Torrecárdenas Almería Spain 04009
5 Hospital U. Puerta del Mar Cádiz Spain 11009
6 Hospital U. Virgen de las Nieves Granada Spain 18014
7 Hospital U. San Cecilio Granada Spain 18016
8 Hospital Juan Ramón Jiménez Huelva Spain 21005
9 Hospital Regional U. de Málaga Málaga Spain 29010
10 Hospital U. Virgen de la Victoria Málaga Spain 29010
11 Hospital Unversitario Virgen Macarena Sevilla Spain 41009
12 Hospital Universitario Virgen del Rocío Sevilla Spain 41013
13 Hospital U. Nuestra Señora de Valme Sevilla Spain 41014
14 Hospital San Juan de Dios Sevilla Spain 41930

Sponsors and Collaborators

  • Andalusian Network for Design and Translation of Advanced Therapies

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andalusian Network for Design and Translation of Advanced Therapies
ClinicalTrials.gov Identifier:
NCT04366245
Other Study ID Numbers:
  • PC/COVID-19
First Posted:
Apr 28, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022