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

Phase 1

Completed

• Conditions: SARS-CoV 2
• Interventions: Biological: Hyperimmune plasma; Drug: Standard of care for SARS-CoV-2 infection

• Registration Number: NCT04366245
• Lead Sponsor: Andalusian Network for Design and Translation of Advanced Therapies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-22
• Study Start: 2020-04-23
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Hyperimmune plasma	-
Comparator	Standard of care for SARS-CoV-2 infection	-

Primary Outcome Measures

Name	Time	Method
Efficacy: Need for mechanical ventilation	Day +21 after randomization
Efficacy: Death from any cause	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.
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: 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

Name	Time	Method
Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.	Before infusion
Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.	Day +21 after randomization
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
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: PCR negative for SARS-CoV-2	On days 7 and 21
Virology and immunological variables: Total antibody quantification	At baseline and on days 3, 7 and 21

Trial Locations

Locations (14)

Hospital U. Torrecárdenas; 🇪🇸 Almería, Spain

Hospital U. San Cecilio; 🇪🇸 Granada, Spain

Hospital Juan Ramón Jiménez; 🇪🇸 Huelva, Spain

Hospital U. Jerez de la Frontera; 🇪🇸 Jerez de la Frontera, Cádiz, Spain

Hospital U. Puerto Real; 🇪🇸 Puerto Real, Cádiz, Spain

Hospital U. Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Costa del Sol; 🇪🇸 Marbella, Málaga, Spain

Hospital U. Puerta del Mar; 🇪🇸 Cádiz, Spain

Hospital U. Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Regional U. de Málaga; 🇪🇸 Málaga, Spain

Hospital Unversitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital San Juan de Dios; 🇪🇸 Sevilla, Spain

Hospital U. Nuestra Señora de Valme; 🇪🇸 Sevilla, Spain