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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-23

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study in the Treatment of Patients With Moderate Course of COVID-19

NCT04842435

COVID-19

UNKNOWN PHASE2/PHASE3

Tocilizumab in Coronavirus-19 Positive Patients

NCT04423042

Covid19 COVID-19 Severe Acute Respiratory Syndrome Coronavirus 2 +2 more

UNKNOWN PHASE3

Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)

NCT04332094

COVID-19

UNKNOWN PHASE2

Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab

NCT05002517

COVID-19 Pneumonia

UNKNOWN PHASE3

Different Susceptibility to SARS CoV-2 Infection Among Health Care Workers Highly Exposed to COVID-19.

NCT04402827

Health Care Worker Patient Transmission Receptor Site Alteration Susceptibility, Disease +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

Group Type EXPERIMENTAL

Hyperimmune plasma

Intervention Type BIOLOGICAL

PLASMA OF CONVALESCENT COVID-19

Comparator

Group Type ACTIVE_COMPARATOR

Standard of care for SARS-CoV-2 infection

Intervention Type DRUG

Standard of care for SARS-CoV-2 infection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hyperimmune plasma

PLASMA OF CONVALESCENT COVID-19

Intervention Type BIOLOGICAL

Standard of care for SARS-CoV-2 infection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No