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

NCT04366245 | Completed Phase 1 DMC

• 1 other identifier: PC/COVID-19
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 14

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.

Conditions

SARS-CoV 2

Outcome Measures

Primary Outcomes (5)

• 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).

  30 days after enrollment

• Efficacy: Death from any cause

  Day +21 after randomization

• Efficacy: Need for mechanical ventilation

  Day +21 after randomization

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

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

  Day +21 after randomization

• 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 Outcomes (10)

• Efficacy. Mortality on days 14 and 28.

  Days 14 and 28.

• Efficacy: Proportion of patients who required mechanical ventilation

  Until day 28

• Efficacy: Proportion of patients who develop analytical alterations.

  Day +21 after randomization.

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

  Day +21 after randomization

• Efficacy: PCR negative for SARS-CoV-2

  On days 7 and 21

Study Arms (2)

Experimental

EXPERIMENTAL

Biological: Hyperimmune plasma

Comparator

ACTIVE COMPARATOR

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

Interventions

Hyperimmune plasma BIOLOGICAL

PLASMA OF CONVALESCENT COVID-19

Experimental

Standard of care for SARS-CoV-2 infection DRUG

Standard of care for SARS-CoV-2 infection

Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andalusian Network for Design and Translation of Advanced Therapies: lead

Study Sites (14)

Hospital U. Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital U. Puerto Real

Puerto Real, Cádiz, 11510, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, 29603, Spain

Location

Hospital U. Torrecárdenas

Almería, 04009, Spain

Location

Hospital U. Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital U. Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital U. San Cecilio

Granada, 18016, Spain

Location

Hospital Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Hospital Regional U. de Málaga

Málaga, 29010, Spain

Location

Hospital U. Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Unversitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital U. Nuestra Señora de Valme

Seville, 41014, Spain

Location

Hospital San Juan de Dios

Seville, 41930, Spain

Location

MeSH Terms

Interventions

COVID-19 Serotherapy; Standard of Care

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 28, 2020
• Study Start: April 23, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

ES (14)