N/A
N=55
Efficacy of Reinforcing Standard Therapy in COVID-19 Patients With Repeated Transfusion of Convalescent Plasma
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04803370 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Convalescent Plasma with antibody against SARS-CoV-2. (Other); Standard treatment for COVID-19 (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital Son Llatzer
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II |
0; 0; 1; 0; 0; 2 | — |
| PRIMARY Adaptive COVID-19 Treatment Trial Scale (ACTT) Version II |
0; 0; 1; 0; 0; 2 | — |
| SECONDARY Anti-SARS-CoV-2 S IgG Serum Titer |
90.28; 98.16; 773.84; 1102.81 | — |
| SECONDARY Time of Hospitalization |
10.5; 8.9 | — |
| SECONDARY Time to Negativization of RT-PCR |
14.6; 12.4 | — |
| SECONDARY Diastolic Blood Pressure |
79.62; 75.21; 77.18; 74.83; 75.25; 74.33 | — |
| SECONDARY Systolic Blood Pressure |
130.62; 121.11; 135; 123.87; 134.2; 121.94 | — |
| SECONDARY Temperature |
36.79; 36.43; 36.59; 36.48; 36.61; 36.50 | — |
| SECONDARY Cardiac Frequency |
83.37; 79.82; 75.54; 79.57; 77.31; 73.73 | — |
| SECONDARY Respiratory Frequency |
20.06; 22.42; 22.36; 23.61; 20.23; 22.65 | — |
| SECONDARY Oxygen Saturation |
95.31; 95.4; 95.63; 95.21; 95.18; 95.78 | — |
| SECONDARY Hemoglobin |
13.38; 13.45; 13.05; 12.83; 12.98; 13.21 | — |
| SECONDARY Leucocytes |
7.81; 7.40; 8.31; 8.67; 10.43; 9.97 | — |
| SECONDARY Neutrophils |
6.11; 5.50; 6.27; 6.37; 7.60; 6.75 | — |
| SECONDARY Absolute Lymphocytes |
1.165; 1.44; 1.32; 1.36; 1.94; 2.07 | — |
| SECONDARY Activated Partial Thromboplastin Time |
29.62; 30.62; 27.96; 29.62; 27.49; 28.72 | — |
| SECONDARY Fibrinogen Level |
713.13; 732.36; 671.94; 683.43; 591.44; 559.77 | — |
| SECONDARY Fragment D-dimer Assessment |
350.26; 294.11; 443.2; 377.52; 321.63; 377.03 | — |
| SECONDARY Glomerular Filtration Rate Assessment |
80.44; 93.65; 86.15; 96.68; 87.04; 96.81 | — |
| SECONDARY Troponin I Assessment |
6.55; 5.45; 5.86; 6.41; 5.50; 6.14 | — |
| SECONDARY Procalcitonin Assessment |
0.86; 0.11; 0.78; 0.09; 0.44; 0.05 | — |
| SECONDARY C-reactive Protein Assessment |
64.19; 55.39; 52.25; 43.51; 33.83; 16.60 | — |
| SECONDARY Lactate Dehydrogenase (LDH) Assessment |
283.56; 306.31; 286.47; 317.18; 276.67; 267.6 | — |
| SECONDARY Interleukin-6 Assessment |
29.48; 32.60; 28.18; 25.37; 17.33; 12.24 | — |
| SECONDARY Ferritin Blood Assessment |
566.48; 745.60; 626.24; 736.80; 624.35; 670.25 | — |
| SECONDARY Percentage of Patients Requiring Admission to Intensive Care Units. |
16; 17; 84; 83 | — |
| SECONDARY Mortality Rate at 15 Days |
0; 0 | — |
| SECONDARY Mortality Rate at 30 Days |
0; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04803370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.