Study name |
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 |
Methods |
Trial design: phase I/II RCT, open‐label, parallel assignment
Sample size: e.g. 36 in each arm (72)
Setting: e.g. inpatient
Country: Spain
Language: English
Number of centres: NR
Inclusion criteria:
Informed consent prior to performing procedures. Oral consent accepted to prevent paper handling.
Patients 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 h before randomisation.
-
Patients requiring hospitalisation for pneumonia COVID‐19 without need until randomisation 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, COPD, liver cirrhosis, or other chronic pulmonary and cardiovascular diseases, diabetes, or obesity
|
Participants |
-
Inclusion criteria:
All sexes
≥ 18 years
Informed consent prior to performing procedures. Oral consent accepted to prevent paper handling.
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 h before randomisation.
-
Patients requiring hospitalisation for pneumonia COVID‐19 without need until randomisation 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, COPD, liver cirrhosis, or other chronic pulmonary and cardiovascular diseases, diabetes, or obesity
-
Exclusion criteria:
Requirement before randomisation of mechanical ventilation (invasive or non‐invasive)
Any of the following analytical data before randomisation: IL‐6 > 80 pg/mL, D‐dimer > 10 times ULN, ferritin > 1000 ng/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 h, 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. (Women of childbearing age considered to be all women from 18 years and up to a year after the last menstrual period in the case of menopausal women)
|
Interventions |
Intervention(s): COVID‐19 hyperimmune CP
-
Details of CP:
Type of plasma: NR
Volume: NR
Number of doses: NR
Antibody‐titre: NR
Pathogen inactivated: NR
Treatment details, including time of plasma therapy (e.g. early stage of disease): before mechanical ventilation is required
Comparator: e.g.. conventional treatment
Concomitant therapy: hydroxychloroquine + azithromycin or lopinavir/ritonavir + interferon β‐1b + hydroxychloroquine
Treatment cross‐overs: no
|
Outcomes |
-
Additional outcomes
Proportion of participants who develop analytical alterations. (time frame: Day +21 after randomisation.). IL‐6 > 40 pg/mL, D‐dimer > 1500, ferritin > 1000 ng/mL until the cure test
Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID‐19) in the cure test. (time frame: Day +21 after randomisation)
PCR‐negative for SARS‐CoV‐2 (time frame: on days 7, 14 and 21)
Proportion of participants who required treatment with tocilizumab (time frame: until day 21)
Virology and immunological variables: qualitative PCR for SARS‐CoV‐2 in naso‐oropharyngeal exudate sample (time frame: at baseline and on day 14)
Virology and immunological variables: total antibody quantification (time frame: at baseline and on days 3, 7, 10 (while hospitalisation lasts), and on days 14 and 28 (if able to return to the clinic or are still hospitalised)
Virology and immunological variables: quantification of total antibodies in PC donors recovered from COVID‐19 (time frame: before infusion)
|
Starting date |
23 April 2020 |
Contact information |
Ana Cardesa Gil 697 95 69 41 ext 0034 ana.cardesa@juntadeandalucia.es Hospital Unversitario Virgen Macarena, Sevilla, Spain, 41009 |
Notes |
Recruitment status: recruiting
Prospective completion date: December 2021
Sponsor/funding: Andalusian Network for Design and Translation of Advanced Therapies
|