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

SARS-CoV 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366245
• Other study ID #: PC/COVID-19
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 23, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2022
• Source: Andalusian Network for Design and Translation of Advanced Therapies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV 2

Intervention

Biological:
• Hyperimmune plasma
PLASMA OF CONVALESCENT COVID-19

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

Locations

Country	Name	City	State
Spain	Hospital U. Torrecárdenas	Almería
Spain	Hospital U. Puerta del Mar	Cádiz
Spain	Hospital U. San Cecilio	Granada
Spain	Hospital U. Virgen de las Nieves	Granada
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital U. Jerez de la Frontera	Jerez de la Frontera	Cádiz
Spain	Hospital Regional U. de Málaga	Málaga
Spain	Hospital U. Virgen de la Victoria	Málaga
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital U. Puerto Real	Puerto Real	Cádiz
Spain	Hospital San Juan de Dios	Sevilla
Spain	Hospital U. Nuestra Señora de Valme	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Unversitario Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Andalusian Network for Design and Translation of Advanced Therapies

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Efficacy: Death from any cause		Day +21 after randomization
Primary	Efficacy: Need for mechanical ventilation		Day +21 after randomization
Primary	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
Primary	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	Efficacy. Mortality on days 14 and 28.		Days 14 and 28.
Secondary	Efficacy: Proportion of patients who required mechanical ventilation		Until day 28
Secondary	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.
Secondary	Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.		Day +21 after randomization
Secondary	Efficacy: PCR negative for SARS-CoV-2		On days 7 and 21
Secondary	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.
Secondary	Efficacy: Duration of hospitalization (days)		Until day 21.
Secondary	Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample		At baseline and on day 21
Secondary	Virology and immunological variables: Total antibody quantification		At baseline and on days 3, 7 and 21
Secondary	Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.		Before infusion