Efficacy of Reinforcing Standard Therapy in COVID-19 Patients With Repeated Transfusion of Convalescent Plasma
Study Details
Study Description
Brief Summary
The coronavirus disease 2019 (COVID-19) was classified as a pandemic by the WHO in March 2020. The SARS-COV-2 virus is easily transmissible and there is currently no approved treatment with effective results. Although the main epidemiological parameters are currently being studied, apparently the speed of contagion, the incidence and the mortality rate in severe cases appear to be high. Therefore, there is an urgent need to find a viable therapeutic option. The present trial is a pilot study with an objective to determine the efficacy of standard treatment reinforced with two repeated doses in two consecutive days of plasma from former convalescent people of the COVID-19 disease already discharged and / or with results in negative COVID-19 screenings, transfused to hospitalized COVID-19 patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Control group Standard treatment for COVID-19 (according to clinical guidelines for COVID-19). |
Other: Standard treatment for COVID-19
The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-α / β, anti-IL-6 monoclonal antibody, oxygen therapy, etc..)
|
| Experimental: Intervention group Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines). |
Other: Convalescent Plasma with antibody against SARS-CoV-2.
Convalescent plasma plus standard treatment for COVID-19. The convalescent plasma is from patients recovered from COVID-19 and negative viremia in the test detection COVID-19.
The infusions will be given on days 1 and 2, of the study, after the positive result for COVID-19 of the recipient patient.
|
Outcome Measures
Primary Outcome Measures
- WHO clinical progression scale [Day 21]
The scale provides a measure of illness severity across a range from 0 (not infected) to 9 (Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO)
Secondary Outcome Measures
- lung X-ray [At inclusion, Day 21]
Evaluation of the lungs with a chest x-ray
- Concomitant medication assessment [At inclusion, Day 3, Day 7, Day 14, Day 21]
Indicate if the patient had to take a concomitant medication and specify the type of medication.
- Hematimetry [At inclusion, Day 3, Day 7, Day 14, Day 21]
blood count
- Activated partial thromboplastin time [At inclusion, Day 3, Day 7, Day 14, Day 21]
measurement of the number of seconds it takes for a clot to form in a patient's blood.
- Fibrinogen level [At inclusion, Day 3, Day 7, Day 14, Day 21]
measurement of the level of fibrinogen in the blood (mg / dl), as a measure of assessing the severity of the disease.
- Fragment D-dimer assessment [At inclusion, Day 3, Day 7, Day 14, Day 21]
Determination of the existence of the D-dimer fragment in blood as a measure of assessing the severity of the disease.
- Glomerular Filtration Rate assessment [At inclusion, Day 3, Day 7, Day 14, Day 21]
estimation of how much blood passes per minute through the glomerular filters of the kidneys (ml/min).
- Ferritin blood assessment [At inclusion, Day 3, Day 7, Day 14, Day 21]
measurement of the amount of ferritin (blood protein) in ng/ml in the blood, as a measure of assessing the severity of the disease.
- C-reactive protein assessment [At inclusion, Day 3, Day 7, Day 14, Day 21]
measurement of the level of c-reactive protein in the blood (mg/dl), as a measure of a change in inflammation
- Lactate Dehydrogenase (LDH) assessment [At inclusion, Day 3, Day 7, Day 14, Day 21]
measurement of the level of lactate dehydrogenase in the blood (U/L), as a measure of assessing the severity of the disease.
- Troponin I assessment [At inclusion, Day 3, Day 7, Day 14, Day 21]
measurement of the levels of troponin I proteins in the blood (ng/L), as a measure of assessing the severity of the disease.
- Procalcitonin assessment [At inclusion, Day 3, Day 7, Day 14, Day 21]
measurement of the levels of procalcitonin in the blood (ng/ml), as a measure of assessing the severity of the disease.
- Interleukin-6 assessment [At inclusion, Day 3, Day 7, Day 14, Day 21]
measurement of serum levels Interleukin-6 in pg/mL, as a measure of assessing the severity of the disease.
- partial pressure of oxygen (pO2) assessment [At inclusion, Day 3, Day 7, Day 14, Day 21]
measurement of the oxygen pressure in the blood (mmHg), as a measure of assessing the severity of the disease.
- Quantitative determination of antibodies [At inclusion, Day 3, Day 7, Day 14, Day 21]
Anti-SARS-Cov 2 immunoglobulin G / A level and anti-SARS-Cov 2 neutralizing antibody levels.
- SARS-Cov-2 viral quantification in a nasopharyngeal specimen [At inclusion, Day 3, Day 7, Day 14, Day 21]
RT-PCR test for the diagnosis of SARS-COV-2 virus
- Time to negativization of RT-PCR [Day 21]
total time elapsed until negative RT-PCR test
- Pneumonia Severity Index (PSI) score [At inclusion, Day 3, Day 7, Day 14, Day 21]
be used to assess the COVID-19 severity and predict the 14-day mortality risk in cases of COVID-19 pneumonia. The patient is then stratified into five classes ( class I: low risk, class V: high risk by his/her score on the PSI scale based on physical or laboratory examination.
- Percentage of patients requiring admission to intensive care units. [At inclusion, Day 3, Day 7, Day 14, Day 21]
- Mortality rate at 15 days [Day 15]
- Mortality rate at 30 days [Day 30]
- Length of stay [Day 21]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ability to understand the HIP and sign the study IC
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male or female =/> 18 years
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Patient hospitalized with a COVID-19 diagnosis by PCR on nasopharyngeal swabs or any other biological sample.
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Presence of respiratory symptoms and / or fever associated with COVID-19, with clinical evolution time for COVID-19 equal to or less than 7 days.
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Presence of pneumonia on chest X-ray and / or SatO2 <94% aa.
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Sequential Organ Failure Assessment (SOFA) score ≤ 6.
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Accept the condition of complying with the procedures established in the protocol.
Exclusion Criteria:
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Patients with a previous history of allergic transfusion reaction.
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Lactating or pregnant women and a positive pregnancy test.
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Patients who have been treated with plasma in the 21 days prior to the screening / baseline visit.
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Patients who are at the time of study, participating in another clinical trial.
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Patients who haven't completed all study procedures.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Son Llatzer | Palma De Mallorca | Islas De Balears | Spain |
Sponsors and Collaborators
- Hospital Son Llatzer
- Fundació d'investigació Sanitària de les Illes Balears
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CO-PLASMA-2020