Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection
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 |
---|---|---|
|
Phase 1/Phase 2 |
Study Design
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
- 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).
- 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. [Day +21 after 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 [Day +21 after randomization]
Secondary Outcome Measures
- 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.]
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. [Day +21 after randomization]
- Efficacy: PCR negative for SARS-CoV-2 [On days 7 and 21]
- 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.
- 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]
Eligibility Criteria
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
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.- PC/COVID-19