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

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 Overview

• Status: Completed
• Conditions: SARS-CoV 2
• Intervention / Treatment: Biological: Hyperimmune plasma; Drug: Standard of care for SARS-CoV-2 infection

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Almería, Spain, 04009
    • Hospital U. Torrecárdenas
  • Cádiz, Spain, 11009
    • Hospital U. Puerta del Mar
  • Granada, Spain, 18014
    • Hospital U. Virgen de las Nieves
  • Granada, Spain, 18016
    • Hospital U. San Cecilio
  • Huelva, Spain, 21005
    • Hospital Juan Ramón Jimenez
  • Málaga, Spain, 29010
    • Hospital Regional U. de Málaga
  • Málaga, Spain, 29010
    • Hospital U. Virgen de la Victoria
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Sevilla, Spain, 41009
    • Hospital Unversitario Virgen Macarena
  • Sevilla, Spain, 41014
    • Hospital U. Nuestra Señora de Valme
  • Sevilla, Spain, 41930
    • Hospital San Juan de Dios
  • Cádiz
    • Jerez de la Frontera, Cádiz, Spain, 11407
      • Hospital U. Jerez de la Frontera
    • Puerto Real, Cádiz, Spain, 11510
      • Hospital U. Puerto Real
  • Málaga
    • Marbella, Málaga, Spain, 29603
      • Hospital Costa del Sol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comparator	Drug: Standard of care for SARS-CoV-2 infection; Standard of care for SARS-CoV-2 infection
Experimental: Experimental	Biological: Hyperimmune plasma; PLASMA OF CONVALESCENT COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL until the cure test.	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
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.	Until day 21.
Efficacy: Duration of hospitalization (days)		Until day 21.
Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample		At baseline and on day 21
Virology and immunological variables: Total antibody quantification		At baseline and on days 3, 7 and 21
Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.		Before infusion

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PC/COVID-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No