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Efficacy of Reinforcing Standard Therapy in COVID-19 Patients With Repeated Transfusion of Convalescent Plasma

Study of the Efficacy of Reinforcing of the Standard Therapy in COVID-19 Patients With Repeated Transfusion of Immune Plasma From COVID-19 Convalescents vs Exclusive Standard Therapy in Hospitalized COVID-19 Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04803370
Enrollment
55
Registered
2021-03-17
Start date
2020-07-08
Completion date
2021-09-01
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COVID19, Immune Plasma

Brief summary

The coronavirus disease 2019 (COVID-19) was classified as a pandemic by the World Health Organization (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.

Interventions

OTHERConvalescent 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.

OTHERStandard 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-Interleukin-6 monoclonal antibody, oxygen therapy, etc..)

Sponsors

Fundació d'investigació Sanitària de les Illes Balears
CollaboratorOTHER_GOV
Hospital Son Llatzer
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Ability to understand the HIP and sign the study IC * male or female =/\> 18 years * Patient hospitalized with a COVID-19 diagnosis by PCR on nasopharyngeal swabs or any other biological sample. * 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. * Presence of pneumonia on chest X-ray and / or SatO2 \<94% aa. * Sequential Organ Failure Assessment (SOFA) score ≤ 6. * Accept the condition of complying with the procedures established in the protocol.

Exclusion criteria

* Patients with a previous history of allergic transfusion reaction. * Lactating or pregnant women and a positive pregnancy test. * Patients who have been treated with plasma in the 21 days prior to the screening / baseline visit. * Patients who are at the time of study, participating in another clinical trial. * Patients who haven't completed all study procedures.

Design outcomes

Primary

MeasureTime frameDescription
Adaptive COVID-19 Treatment Trial Scale (ACTT) Version IIDay 7The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19. * 1= Death * 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices * 4= Hospitalized. requiring supplemental oxygen * 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) * 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care. * 7= Not hospitalized. limitation on activities and/or requiring home oxygen * 8= Not hospitalized. no limitations on activities.

Secondary

MeasureTime frameDescription
Interleukin-6 AssessmentAt inclusion, Day 3, Day 7, Day 14, Day 21measurement of serum levels Interleukin-6 in pg/mL, as a measure of assessing the severity of the disease.
Anti-SARS-CoV-2 S IgG Serum TiterAt inclusion, Day 21The levels of Anti-SARS-CoV-2 S IgG serum
Ferritin Blood AssessmentAt inclusion, Day 3, Day 7, Day 14, Day 21measurement of the amount of ferritin (blood protein) in ng/ml in the blood, as a measure of assessing the severity of the disease.
Percentage of Patients Requiring Admission to Intensive Care Units.Day 21Percentage of patients requiring admission to intensive care units.
Mortality Rate at 15 DaysDay 15number of dead participants through day 15
Time of HospitalizationDay 21time that the patients have passed in the hospital.
Time to Negativization of RT-PCRDay 21total time elapsed until negative RT-PCR test
Diastolic Blood PressureAt inclusion, Day 1, Day 3, Day 7, Day 14, Day 21the pressure of blood in the artery when the heart relaxes between beats.
Systolic Blood PressureAt inclusion, Day 1, Day 3, Day 7, Day 14, Day 21The pressure of blood in the artery when the heart contracts. It is the high number in a blood pressure measurement.
TemperatureAt inclusion, Day 1, Day 3, Day 7, Day 14, Day 21—
Cardiac FrequencyAt inclusion, Day 1, Day 3, Day 7, Day 14, Day 21The number of heart contractions or beats per unit of time. The normal values in adults at rest range between 60 and 100 beats per minit.
Respiratory FrequencyAt inclusion, Day 1, Day 3, Day 7, Day 14, Day 21Number of breaths the patient takes per minute.
Lactate Dehydrogenase (LDH) AssessmentAt inclusion, Day 3, Day 7, Day 14, Day 21measurement of the level of lactate dehydrogenase in the blood (U/L), as a measure of assessing the severity of the disease.
HemoglobinAt inclusion, Day 3, Day 7, Day 14, Day 21hemoglobin levels in the blood
LeucocytesAt inclusion, Day 3, Day 7, Day 14, Day 21Leucocyte count a patient's blood.
NeutrophilsAt inclusion, Day 3, Day 7, Day 14, Day 21Neutrophils count a patient's blood.
Absolute LymphocytesAt inclusion, Day 3, Day 7, Day 14, Day 21lymphocyte count a patient's blood.
Activated Partial Thromboplastin TimeAt inclusion, Day 3, Day 7, Day 14, Day 21measurement of the number of seconds it takes for a clot to form in a patient's blood.
Fibrinogen LevelAt inclusion, Day 3, Day 7, Day 14, Day 21measurement of the level of fibrinogen in the blood (mg / dl), as a measure of assessing the severity of the disease.
Fragment D-dimer AssessmentAt inclusion, Day 3, Day 7, Day 14Determination of the existence of the D-dimer fragment in blood as a measure of assessing the severity of the disease.
Glomerular Filtration Rate AssessmentAt inclusion, Day 3, Day 7, Day 14, Day 21estimation of how much blood passes per minute through the glomerular filters of the kidneys (ml/min).
Troponin I AssessmentAt inclusion, Day 3, Day 7, Day 14, Day 21measurement of the levels of troponin I proteins in the blood (ng/mL), as a measure of assessing the severity of the disease.
Procalcitonin AssessmentAt inclusion, Day 3, Day 7, Day 14, Day 21measurement of the levels of procalcitonin in the blood (ng/L), as a measure of assessing the severity of the disease.
C-reactive Protein AssessmentAt inclusion, Day 3, Day 7, Day 14, Day 21measurement of the level of c-reactive protein in the blood (mg/dl), as a measure of a change in inflammation
Mortality Rate at 30 DaysDay 30number of dead participants through day 30
Oxygen SaturationAt inclusion, Day 1, Day 3, Day 7, Day 14, Day 21blood oxygen percentage. A healthy percentage of oxygen in the blood is between 95% and 100%.

Countries

Spain

Participant flow

Participants by arm

ArmCount
Control Group
Standard treatment for COVID-19 (according to clinical guidelines for COVID-19).
17
Intervention Group
Convalescent patient plasma 300 ml given in 2 consecutive days, plus standard treatment for COVID-19 (according to clinical guidelines).
37
Total54

Baseline characteristics

CharacteristicControl GroupIntervention GroupTotal
Age, Continuous59 years
STANDARD_DEVIATION 3
58 years
STANDARD_DEVIATION 2
58 years
STANDARD_DEVIATION 1.87
Body Mass Index30.34 kg/m^2
STANDARD_DEVIATION 1.99
30.72 kg/m^2
STANDARD_DEVIATION 1.24
30.62 kg/m^2
STANDARD_DEVIATION 1.05
Concomitant illnesses
No
3 Participants10 Participants13 Participants
Concomitant illnesses
Yes
14 Participants27 Participants41 Participants
Concomitant medication
No
10 Participants20 Participants30 Participants
Concomitant medication
Yes
7 Participants17 Participants24 Participants
Drug abuse habits
No
16 Participants35 Participants51 Participants
Drug abuse habits
Yes
1 Participants2 Participants3 Participants
Race and Ethnicity Not Collected——0 Participants
Sex: Female, Male
Female
7 Participants14 Participants21 Participants
Sex: Female, Male
Male
10 Participants23 Participants33 Participants
Smoke
No
16 Participants35 Participants51 Participants
Smoke
Yes
1 Participants2 Participants3 Participants
Standard treatment
Antibiotic
3 participants10 participants13 participants
Standard treatment
Anticoagulant
5 participants13 participants18 participants
Standard treatment
Antiinflammatory
11 participants29 participants40 participants
Standard treatment
Antiviral
5 participants14 participants19 participants
Standard treatment
Oxygen therapy
10 participants19 participants29 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 170 / 37
other
Total, other adverse events
0 / 174 / 37
serious
Total, serious adverse events
0 / 170 / 37

Outcome results

Primary

Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II

The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19. * 1= Death * 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices * 4= Hospitalized. requiring supplemental oxygen * 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) * 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care. * 7= Not hospitalized. limitation on activities and/or requiring home oxygen * 8= Not hospitalized. no limitations on activities.

Time frame: Day 7

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 10 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 20 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 32 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 45 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 54 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 62 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 71 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 83 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 812 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 10 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 510 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 20 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 73 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 33 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 63 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 46 Participants
Primary

Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II

The scale provides a measure of COVID-19 severity based on the patient's physical situation, whose design was based on a blueprint of the WHO in treating COVID-19. * 1= Death * 2= Hospitalized. on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * 3= Hospitalized. on non-invasive ventilation or high flow oxygen devices * 4= Hospitalized. requiring supplemental oxygen * 5= Hospitalized. not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) * 6= Hospitalized. not requiring supplemental oxygen - no longer requiring ongoing medical care. * 7= Not hospitalized. limitation on activities and/or requiring home oxygen * 8= Not hospitalized. no limitations on activities.

Time frame: Day 14

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 41 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 86 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 10 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 21 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 30 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 51 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 63 Participants
Control GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 75 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 818 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 42 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 79 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 32 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 63 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 10 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 53 Participants
Intervention GroupAdaptive COVID-19 Treatment Trial Scale (ACTT) Version IIGrade 20 Participants
Secondary

Absolute Lymphocytes

lymphocyte count a patient's blood.

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupAbsolute LymphocytesDay 31.32 cells x10^9/LStandard Error 0.17
Control GroupAbsolute LymphocytesDay 142.02 cells x10^9/LStandard Error 0.21
Control GroupAbsolute LymphocytesDay 71.94 cells x10^9/LStandard Error 0.26
Control GroupAbsolute LymphocytesDay 211.63 cells x10^9/LStandard Error 0.18
Control GroupAbsolute LymphocytesAt inclusion1.165 cells x10^9/LStandard Error 0.11
Intervention GroupAbsolute LymphocytesDay 211.88 cells x10^9/LStandard Error 0.12
Intervention GroupAbsolute LymphocytesAt inclusion1.44 cells x10^9/LStandard Error 0.15
Intervention GroupAbsolute LymphocytesDay 31.36 cells x10^9/LStandard Error 0.1
Intervention GroupAbsolute LymphocytesDay 72.07 cells x10^9/LStandard Error 0.16
Intervention GroupAbsolute LymphocytesDay 142.14 cells x10^9/LStandard Error 0.15
Secondary

Activated Partial Thromboplastin Time

measurement of the number of seconds it takes for a clot to form in a patient's blood.

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupActivated Partial Thromboplastin TimeDay 327.96 secondsStandard Error 0.64
Control GroupActivated Partial Thromboplastin TimeDay 1428.29 secondsStandard Error 0.88
Control GroupActivated Partial Thromboplastin TimeDay 727.49 secondsStandard Error 0.62
Control GroupActivated Partial Thromboplastin TimeDay 2131.39 secondsStandard Error 2.03
Control GroupActivated Partial Thromboplastin TimeAt inclusion29.62 secondsStandard Error 1.43
Intervention GroupActivated Partial Thromboplastin TimeDay 2131.12 secondsStandard Error 0.73
Intervention GroupActivated Partial Thromboplastin TimeAt inclusion30.62 secondsStandard Error 0.7
Intervention GroupActivated Partial Thromboplastin TimeDay 329.62 secondsStandard Error 0.76
Intervention GroupActivated Partial Thromboplastin TimeDay 728.72 secondsStandard Error 0.73
Intervention GroupActivated Partial Thromboplastin TimeDay 1429.37 secondsStandard Error 0.67
Secondary

Anti-SARS-CoV-2 S IgG Serum Titer

The levels of Anti-SARS-CoV-2 S IgG serum

Time frame: At inclusion, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupAnti-SARS-CoV-2 S IgG Serum TiterAt inclusion90.28 AU/ mlStandard Error 53.51
Control GroupAnti-SARS-CoV-2 S IgG Serum TiterDay 21773.84 AU/ mlStandard Error 327.53
Intervention GroupAnti-SARS-CoV-2 S IgG Serum TiterAt inclusion98.16 AU/ mlStandard Error 39.89
Intervention GroupAnti-SARS-CoV-2 S IgG Serum TiterDay 211102.81 AU/ mlStandard Error 194.51
Secondary

Cardiac Frequency

The number of heart contractions or beats per unit of time. The normal values in adults at rest range between 60 and 100 beats per minit.

Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupCardiac FrequencyAt inclusion83.37 beats/minitStandard Error 4.05
Control GroupCardiac FrequencyDay 175.54 beats/minitStandard Error 4.08
Control GroupCardiac FrequencyDay 377.31 beats/minitStandard Error 3.16
Control GroupCardiac FrequencyDay 779.77 beats/minitStandard Error 4.28
Control GroupCardiac FrequencyDay 1486.27 beats/minitStandard Error 5.71
Control GroupCardiac FrequencyDay 2184.90 beats/minitStandard Error 5.31
Intervention GroupCardiac FrequencyDay 1485.38 beats/minitStandard Error 2.66
Intervention GroupCardiac FrequencyAt inclusion79.82 beats/minitStandard Error 2.25
Intervention GroupCardiac FrequencyDay 768.35 beats/minitStandard Error 2.24
Intervention GroupCardiac FrequencyDay 179.57 beats/minitStandard Error 2.34
Intervention GroupCardiac FrequencyDay 2186.72 beats/minitStandard Error 3.01
Intervention GroupCardiac FrequencyDay 373.73 beats/minitStandard Error 2.1
Secondary

C-reactive Protein Assessment

measurement of the level of c-reactive protein in the blood (mg/dl), as a measure of a change in inflammation

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupC-reactive Protein AssessmentDay 352.25 mg/dLStandard Error 12.77
Control GroupC-reactive Protein AssessmentDay 1418.49 mg/dLStandard Error 4.85
Control GroupC-reactive Protein AssessmentDay 733.83 mg/dLStandard Error 11.42
Control GroupC-reactive Protein AssessmentDay 2117.46 mg/dLStandard Error 5.35
Control GroupC-reactive Protein AssessmentAt inclusion64.19 mg/dLStandard Error 15.81
Intervention GroupC-reactive Protein AssessmentDay 218.72 mg/dLStandard Error 1.72
Intervention GroupC-reactive Protein AssessmentAt inclusion55.39 mg/dLStandard Error 9.2
Intervention GroupC-reactive Protein AssessmentDay 343.51 mg/dLStandard Error 8.67
Intervention GroupC-reactive Protein AssessmentDay 716.60 mg/dLStandard Error 3.55
Intervention GroupC-reactive Protein AssessmentDay 149.18 mg/dLStandard Error 1.97
Secondary

Diastolic Blood Pressure

the pressure of blood in the artery when the heart relaxes between beats.

Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupDiastolic Blood PressureAt inclusion79.62 mmHgStandard Error 3.17
Control GroupDiastolic Blood PressureDay 177.18 mmHgStandard Error 5.01
Control GroupDiastolic Blood PressureDay 375.25 mmHgStandard Error 2.84
Control GroupDiastolic Blood PressureDay 781.07 mmHgStandard Error 3.53
Control GroupDiastolic Blood PressureDay 1480.72 mmHgStandard Error 5.06
Control GroupDiastolic Blood PressureDay 2183.83 mmHgStandard Error 3.91
Intervention GroupDiastolic Blood PressureDay 1478.96 mmHgStandard Error 1.71
Intervention GroupDiastolic Blood PressureAt inclusion75.21 mmHgStandard Error 2.12
Intervention GroupDiastolic Blood PressureDay 772.48 mmHgStandard Error 1.38
Intervention GroupDiastolic Blood PressureDay 174.83 mmHgStandard Error 1.72
Intervention GroupDiastolic Blood PressureDay 2181.85 mmHgStandard Error 1.82
Intervention GroupDiastolic Blood PressureDay 374.33 mmHgStandard Error 2.08
Secondary

Ferritin Blood Assessment

measurement of the amount of ferritin (blood protein) in ng/ml in the blood, as a measure of assessing the severity of the disease.

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupFerritin Blood AssessmentDay 7624.35 ng/mLStandard Deviation 124.99
Control GroupFerritin Blood AssessmentDay 3626.24 ng/mLStandard Deviation 136.86
Control GroupFerritin Blood AssessmentDay 14412.88 ng/mLStandard Deviation 78.48
Control GroupFerritin Blood AssessmentDay 21392.57 ng/mLStandard Deviation 123.7
Control GroupFerritin Blood AssessmentAt inclusion566.48 ng/mLStandard Deviation 158.23
Intervention GroupFerritin Blood AssessmentDay 21272.27 ng/mLStandard Deviation 48.16
Intervention GroupFerritin Blood AssessmentAt inclusion745.60 ng/mLStandard Deviation 129.99
Intervention GroupFerritin Blood AssessmentDay 3736.80 ng/mLStandard Deviation 119.52
Intervention GroupFerritin Blood AssessmentDay 7670.25 ng/mLStandard Deviation 92.21
Intervention GroupFerritin Blood AssessmentDay 14450.42 ng/mLStandard Deviation 60.09
Secondary

Fibrinogen Level

measurement of the level of fibrinogen in the blood (mg / dl), as a measure of assessing the severity of the disease.

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupFibrinogen LevelDay 3671.94 mg/dLStandard Error 42.38
Control GroupFibrinogen LevelDay 14562.67 mg/dLStandard Error 38.92
Control GroupFibrinogen LevelDay 7591.44 mg/dLStandard Error 36.4
Control GroupFibrinogen LevelDay 21527.23 mg/dLStandard Error 39.46
Control GroupFibrinogen LevelAt inclusion713.13 mg/dLStandard Error 44.64
Intervention GroupFibrinogen LevelDay 21511.96 mg/dLStandard Error 33.35
Intervention GroupFibrinogen LevelAt inclusion732.36 mg/dLStandard Error 32.57
Intervention GroupFibrinogen LevelDay 3683.43 mg/dLStandard Error 33.11
Intervention GroupFibrinogen LevelDay 7559.77 mg/dLStandard Error 32.01
Intervention GroupFibrinogen LevelDay 14531.46 mg/dLStandard Error 35.71
Secondary

Fragment D-dimer Assessment

Determination of the existence of the D-dimer fragment in blood as a measure of assessing the severity of the disease.

Time frame: At inclusion, Day 3, Day 7, Day 14

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupFragment D-dimer AssessmentAt inclusion350.26 ng/mLStandard Error 62.8
Control GroupFragment D-dimer AssessmentDay 3443.2 ng/mLStandard Error 77.12
Control GroupFragment D-dimer AssessmentDay 7321.63 ng/mLStandard Error 61.81
Control GroupFragment D-dimer AssessmentDay 14300.69 ng/mLStandard Error 51.74
Intervention GroupFragment D-dimer AssessmentDay 14222.8 ng/mLStandard Error 24.66
Intervention GroupFragment D-dimer AssessmentAt inclusion294.11 ng/mLStandard Error 36.63
Intervention GroupFragment D-dimer AssessmentDay 7377.03 ng/mLStandard Error 91.58
Intervention GroupFragment D-dimer AssessmentDay 3377.52 ng/mLStandard Error 117.12
Secondary

Glomerular Filtration Rate Assessment

estimation of how much blood passes per minute through the glomerular filters of the kidneys (ml/min).

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupGlomerular Filtration Rate AssessmentDay 386.15 ml/minStandard Error 4.07
Control GroupGlomerular Filtration Rate AssessmentDay 1480.17 ml/minStandard Error 5.29
Control GroupGlomerular Filtration Rate AssessmentDay 787.04 ml/minStandard Error 4.6
Control GroupGlomerular Filtration Rate AssessmentDay 2183.98 ml/minStandard Error 4.59
Control GroupGlomerular Filtration Rate AssessmentAt inclusion80.44 ml/minStandard Error 5.41
Intervention GroupGlomerular Filtration Rate AssessmentDay 2192.53 ml/minStandard Error 3.71
Intervention GroupGlomerular Filtration Rate AssessmentAt inclusion93.65 ml/minStandard Error 3.31
Intervention GroupGlomerular Filtration Rate AssessmentDay 396.68 ml/minStandard Error 3.35
Intervention GroupGlomerular Filtration Rate AssessmentDay 796.81 ml/minStandard Error 3.55
Intervention GroupGlomerular Filtration Rate AssessmentDay 1492.24 ml/minStandard Error 3.35
Secondary

Hemoglobin

hemoglobin levels in the blood

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupHemoglobinDay 313.05 g/dLStandard Error 0.34
Control GroupHemoglobinDay 1412.94 g/dLStandard Error 0.31
Control GroupHemoglobinDay 712.98 g/dLStandard Error 0.37
Control GroupHemoglobinDay 2112.51 g/dLStandard Error 0.4
Control GroupHemoglobinAt inclusion13.38 g/dLStandard Error 0.31
Intervention GroupHemoglobinDay 2113.04 g/dLStandard Error 0.37
Intervention GroupHemoglobinAt inclusion13.45 g/dLStandard Error 0.29
Intervention GroupHemoglobinDay 312.83 g/dLStandard Error 0.31
Intervention GroupHemoglobinDay 713.21 g/dLStandard Error 0.35
Intervention GroupHemoglobinDay 1413.37 g/dLStandard Error 0.28
Secondary

Interleukin-6 Assessment

measurement of serum levels Interleukin-6 in pg/mL, as a measure of assessing the severity of the disease.

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupInterleukin-6 AssessmentDay 328.18 pg/mLStandard Error 4.1
Control GroupInterleukin-6 AssessmentDay 1411.31 pg/mLStandard Error 3.45
Control GroupInterleukin-6 AssessmentDay 717.33 pg/mLStandard Error 3.54
Control GroupInterleukin-6 AssessmentDay 2110.76 pg/mLStandard Error 2.68
Control GroupInterleukin-6 AssessmentAt inclusion29.48 pg/mLStandard Error 6.01
Intervention GroupInterleukin-6 AssessmentDay 2111.80 pg/mLStandard Error 3.31
Intervention GroupInterleukin-6 AssessmentAt inclusion32.60 pg/mLStandard Error 5.21
Intervention GroupInterleukin-6 AssessmentDay 325.37 pg/mLStandard Error 5.83
Intervention GroupInterleukin-6 AssessmentDay 712.24 pg/mLStandard Error 3.12
Intervention GroupInterleukin-6 AssessmentDay 1412.02 pg/mLStandard Error 2.53
Secondary

Lactate Dehydrogenase (LDH) Assessment

measurement of the level of lactate dehydrogenase in the blood (U/L), as a measure of assessing the severity of the disease.

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupLactate Dehydrogenase (LDH) AssessmentDay 3286.47 Unit/LStandard Error 15.27
Control GroupLactate Dehydrogenase (LDH) AssessmentDay 14277 Unit/LStandard Error 27.41
Control GroupLactate Dehydrogenase (LDH) AssessmentDay 7276.67 Unit/LStandard Error 17.5
Control GroupLactate Dehydrogenase (LDH) AssessmentDay 21246.38 Unit/LStandard Error 21.33
Control GroupLactate Dehydrogenase (LDH) AssessmentAt inclusion283.56 Unit/LStandard Error 12.78
Intervention GroupLactate Dehydrogenase (LDH) AssessmentDay 21215.04 Unit/LStandard Error 8.1
Intervention GroupLactate Dehydrogenase (LDH) AssessmentAt inclusion306.31 Unit/LStandard Error 21.8
Intervention GroupLactate Dehydrogenase (LDH) AssessmentDay 3317.18 Unit/LStandard Error 25.14
Intervention GroupLactate Dehydrogenase (LDH) AssessmentDay 7267.6 Unit/LStandard Error 16.95
Intervention GroupLactate Dehydrogenase (LDH) AssessmentDay 14232.25 Unit/LStandard Error 9.21
Secondary

Leucocytes

Leucocyte count a patient's blood.

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupLeucocytesDay 710.43 cells x10^9/LStandard Error 0.87
Control GroupLeucocytesDay 149.32 cells x10^9/LStandard Error 1.08
Control GroupLeucocytesAt inclusion7.81 cells x10^9/LStandard Error 0.87
Control GroupLeucocytesDay 216.47 cells x10^9/LStandard Error 0.61
Control GroupLeucocytesDay 38.31 cells x10^9/LStandard Error 0.9
Intervention GroupLeucocytesDay 216.20 cells x10^9/LStandard Error 0.45
Intervention GroupLeucocytesDay 38.67 cells x10^9/LStandard Error 0.65
Intervention GroupLeucocytesAt inclusion7.40 cells x10^9/LStandard Error 0.46
Intervention GroupLeucocytesDay 79.97 cells x10^9/LStandard Error 0.66
Intervention GroupLeucocytesDay 149.40 cells x10^9/LStandard Error 0.82
Secondary

Mortality Rate at 15 Days

number of dead participants through day 15

Time frame: Day 15

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control GroupMortality Rate at 15 Days0 Participants
Intervention GroupMortality Rate at 15 Days0 Participants
Secondary

Mortality Rate at 30 Days

number of dead participants through day 30

Time frame: Day 30

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control GroupMortality Rate at 30 Days0 Participants
Intervention GroupMortality Rate at 30 Days0 Participants
Secondary

Neutrophils

Neutrophils count a patient's blood.

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupNeutrophilsDay 36.27 cells x10^9/LStandard Error 0.85
Control GroupNeutrophilsDay 146.53 cells x10^9/LStandard Error 1.16
Control GroupNeutrophilsDay 77.60 cells x10^9/LStandard Error 0.78
Control GroupNeutrophilsDay 214.17 cells x10^9/LStandard Error 0.59
Control GroupNeutrophilsAt inclusion6.11 cells x10^9/LStandard Error 0.86
Intervention GroupNeutrophilsDay 213.74 cells x10^9/LStandard Error 0.4
Intervention GroupNeutrophilsAt inclusion5.50 cells x10^9/LStandard Error 0.48
Intervention GroupNeutrophilsDay 36.37 cells x10^9/LStandard Error 0.61
Intervention GroupNeutrophilsDay 76.75 cells x10^9/LStandard Error 0.68
Intervention GroupNeutrophilsDay 146.58 cells x10^9/LStandard Error 0.83
Secondary

Oxygen Saturation

blood oxygen percentage. A healthy percentage of oxygen in the blood is between 95% and 100%.

Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupOxygen SaturationAt inclusion95.31 percentage of blood oxygenStandard Error 0.73
Control GroupOxygen SaturationDay 195.63 percentage of blood oxygenStandard Error 0.67
Control GroupOxygen SaturationDay 395.18 percentage of blood oxygenStandard Error 0.51
Control GroupOxygen SaturationDay 794.69 percentage of blood oxygenStandard Error 0.82
Control GroupOxygen SaturationDay 1495.1 percentage of blood oxygenStandard Error 0.54
Control GroupOxygen SaturationDay 2196 percentage of blood oxygenStandard Error 0.52
Intervention GroupOxygen SaturationDay 1495.73 percentage of blood oxygenStandard Error 0.43
Intervention GroupOxygen SaturationAt inclusion95.4 percentage of blood oxygenStandard Error 0.42
Intervention GroupOxygen SaturationDay 795.82 percentage of blood oxygenStandard Error 0.42
Intervention GroupOxygen SaturationDay 195.21 percentage of blood oxygenStandard Error 0.94
Intervention GroupOxygen SaturationDay 2196.15 percentage of blood oxygenStandard Error 0.37
Intervention GroupOxygen SaturationDay 395.78 percentage of blood oxygenStandard Error 0.38
Secondary

Percentage of Patients Requiring Admission to Intensive Care Units.

Percentage of patients requiring admission to intensive care units.

Time frame: Day 21

ArmMeasureGroupValue (NUMBER)
Control GroupPercentage of Patients Requiring Admission to Intensive Care Units.yes16 percentage of participants
Control GroupPercentage of Patients Requiring Admission to Intensive Care Units.No84 percentage of participants
Intervention GroupPercentage of Patients Requiring Admission to Intensive Care Units.yes17 percentage of participants
Intervention GroupPercentage of Patients Requiring Admission to Intensive Care Units.No83 percentage of participants
Secondary

Procalcitonin Assessment

measurement of the levels of procalcitonin in the blood (ng/L), as a measure of assessing the severity of the disease.

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupProcalcitonin AssessmentDay 30.78 ng/LStandard Error 0.7
Control GroupProcalcitonin AssessmentDay 140.04 ng/LStandard Error 0.005
Control GroupProcalcitonin AssessmentDay 70.44 ng/LStandard Error 0.39
Control GroupProcalcitonin AssessmentDay 210.05 ng/LStandard Error 0.01
Control GroupProcalcitonin AssessmentAt inclusion0.86 ng/LStandard Error 0.73
Intervention GroupProcalcitonin AssessmentDay 210.04 ng/LStandard Error 0.01
Intervention GroupProcalcitonin AssessmentAt inclusion0.11 ng/LStandard Error 0.02
Intervention GroupProcalcitonin AssessmentDay 30.09 ng/LStandard Error 0.02
Intervention GroupProcalcitonin AssessmentDay 70.05 ng/LStandard Error 0.01
Intervention GroupProcalcitonin AssessmentDay 140.04 ng/LStandard Error 0.004
Secondary

Respiratory Frequency

Number of breaths the patient takes per minute.

Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupRespiratory FrequencyAt inclusion20.06 breath/minutStandard Error 1.27
Control GroupRespiratory FrequencyDay 122.36 breath/minutStandard Error 1.2
Control GroupRespiratory FrequencyDay 320.23 breath/minutStandard Error 0.92
Control GroupRespiratory FrequencyDay 721.12 breath/minutStandard Error 1.29
Control GroupRespiratory FrequencyDay 1418.16 breath/minutStandard Error 1.27
Control GroupRespiratory FrequencyDay 2116.43 breath/minutStandard Error 0.61
Intervention GroupRespiratory FrequencyDay 1418.42 breath/minutStandard Error 0.66
Intervention GroupRespiratory FrequencyAt inclusion22.42 breath/minutStandard Error 1.25
Intervention GroupRespiratory FrequencyDay 719.95 breath/minutStandard Error 1.05
Intervention GroupRespiratory FrequencyDay 123.61 breath/minutStandard Error 1.13
Intervention GroupRespiratory FrequencyDay 2119.38 breath/minutStandard Error 1.11
Intervention GroupRespiratory FrequencyDay 322.65 breath/minutStandard Error 0.98
Secondary

Systolic Blood Pressure

The pressure of blood in the artery when the heart contracts. It is the high number in a blood pressure measurement.

Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupSystolic Blood PressureAt inclusion130.62 mmHgStandard Error 5.84
Control GroupSystolic Blood PressureDay 1135 mmHgStandard Error 7.53
Control GroupSystolic Blood PressureDay 3134.2 mmHgStandard Error 3.34
Control GroupSystolic Blood PressureDay 7141.53 mmHgStandard Error 6.85
Control GroupSystolic Blood PressureDay 14145.8 mmHgStandard Error 6.57
Control GroupSystolic Blood PressureDay 21145.81 mmHgStandard Error 6.01
Intervention GroupSystolic Blood PressureDay 14125.77 mmHgStandard Error 2.56
Intervention GroupSystolic Blood PressureAt inclusion121.11 mmHgStandard Error 3.25
Intervention GroupSystolic Blood PressureDay 7119.48 mmHgStandard Error 2.82
Intervention GroupSystolic Blood PressureDay 1123.87 mmHgStandard Error 3.25
Intervention GroupSystolic Blood PressureDay 21128.39 mmHgStandard Error 2.84
Intervention GroupSystolic Blood PressureDay 3121.94 mmHgStandard Error 2.15
Secondary

Temperature

Time frame: At inclusion, Day 1, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupTemperatureAt inclusion36.79 degrees CelsiusStandard Error 0.26
Control GroupTemperatureDay 136.59 degrees CelsiusStandard Error 0.14
Control GroupTemperatureDay 336.61 degrees CelsiusStandard Error 0.19
Control GroupTemperatureDay 736.24 degrees CelsiusStandard Error 0.17
Control GroupTemperatureDay 1436.58 degrees CelsiusStandard Error 0.18
Control GroupTemperatureDay 2136.26 degrees CelsiusStandard Error 0.1
Intervention GroupTemperatureDay 1436.46 degrees CelsiusStandard Error 0.1
Intervention GroupTemperatureAt inclusion36.43 degrees CelsiusStandard Error 0.14
Intervention GroupTemperatureDay 736.17 degrees CelsiusStandard Error 0.09
Intervention GroupTemperatureDay 136.48 degrees CelsiusStandard Error 0.09
Intervention GroupTemperatureDay 2136.38 degrees CelsiusStandard Error 0.1
Intervention GroupTemperatureDay 336.50 degrees CelsiusStandard Error 0.11
Secondary

Time of Hospitalization

time that the patients have passed in the hospital.

Time frame: Day 21

ArmMeasureValue (MEAN)Dispersion
Control GroupTime of Hospitalization10.5 daysStandard Error 1.8
Intervention GroupTime of Hospitalization8.9 daysStandard Error 0.9
Secondary

Time to Negativization of RT-PCR

total time elapsed until negative RT-PCR test

Time frame: Day 21

ArmMeasureValue (MEAN)Dispersion
Control GroupTime to Negativization of RT-PCR14.6 daysStandard Error 2.1
Intervention GroupTime to Negativization of RT-PCR12.4 daysStandard Error 1.4
Secondary

Troponin I Assessment

measurement of the levels of troponin I proteins in the blood (ng/mL), as a measure of assessing the severity of the disease.

Time frame: At inclusion, Day 3, Day 7, Day 14, Day 21

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupTroponin I AssessmentDay 35.86 ng/mLStandard Error 1.57
Control GroupTroponin I AssessmentDay 145.24 ng/mLStandard Error 1.8
Control GroupTroponin I AssessmentDay 75.50 ng/mLStandard Error 1.56
Control GroupTroponin I AssessmentDay 215.44 ng/mLStandard Error 1.27
Control GroupTroponin I AssessmentAt inclusion6.55 ng/mLStandard Error 1.59
Intervention GroupTroponin I AssessmentDay 214.24 ng/mLStandard Error 0.56
Intervention GroupTroponin I AssessmentAt inclusion5.45 ng/mLStandard Error 0.65
Intervention GroupTroponin I AssessmentDay 36.41 ng/mLStandard Error 0.78
Intervention GroupTroponin I AssessmentDay 76.14 ng/mLStandard Error 1.1
Intervention GroupTroponin I AssessmentDay 144.32 ng/mLStandard Error 0.57

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026