Clinical trial NCT04366245: Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: SARS-CoV 2
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 30 days after enrollment
measure: Efficacy: Death from any cause
timeFrame: Day +21 after randomization
measure: Efficacy: Need for mechanical ventilation
timeFrame: Day +21 after randomization
measure: Efficacy: Any of the following analytical data after 72h of randomization.
timeFrame: Day +21 after randomization
measure: Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level
timeFrame: Day +21 after randomization
Secondary outcomes:
measure: Efficacy. Mortality on days 14 and 28.
timeFrame: Days 14 and 28.
measure: Efficacy: Proportion of patients who required mechanical ventilation
timeFrame: Until day 28
measure: Efficacy: Proportion of patients who develop analytical alterations.
timeFrame: Day +21 after randomization.
measure: Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.
timeFrame: Day +21 after randomization
measure: Efficacy: PCR negative for SARS-CoV-2
timeFrame: On days 7 and 21
measure: Efficacy: Proportion of patients requiring treatment.
timeFrame: Until day 21.
measure: Efficacy: Duration of hospitalization (days)
timeFrame: Until day 21.
measure: Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample
timeFrame: At baseline and on day 21
measure: Virology and immunological variables: Total antibody quantification
timeFrame: At baseline and on days 3, 7 and 21
measure: Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.
timeFrame: Before infusion
Other outcomes:
Locations:
city: Jerez de la Frontera
country: Spain
facility: Hospital U. Jerez de la Frontera
state: Cádiz
city: Puerto Real
country: Spain
facility: Hospital U. Puerto Real
state: Cádiz
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Almería
country: Spain
facility: Hospital U. Torrecárdenas
city: Cádiz
country: Spain
facility: Hospital U. Puerta del Mar
city: Granada
country: Spain
facility: Hospital U. Virgen de las Nieves
city: Granada
country: Spain
facility: Hospital U. San Cecilio
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Málaga
country: Spain
facility: Hospital Regional U. de Málaga
city: Málaga
country: Spain
facility: Hospital U. Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Unversitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital U. Nuestra Señora de Valme
city: Sevilla
country: Spain
facility: Hospital San Juan de Dios
Study officials:
References: