Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministério da Ciência, Tecnologia, Inovações e Comunicações | UNKNOWN |
| Faculty of Medicine of Ribeirão Preto (FMRP-USP) | OTHER |
| Hospital de Clínicas, Faculdade de Medicina Universidade Estadual de Campinas |
Not provided
Not provided
Not provided
Not provided
The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of convalescent plasma in treatment of severe cases of COVID-19 in a multicenter, randomized, open-label and controlled study
Eligible patients will be randomized 1:1:1 into 3 treatment groups: A- standard (control); B- standard and convalescent plasma in a volume of 200ml (150-300ml); C- standard and convalescent plasma in a volume of 400ml (300-600ml). The Bayesian multi-arm and multi-stage model will be used, which will allow an interim analysis after the inclusion of 30 patients, with repeated interim analyses for every 30 additional patients. With this, we expect to define not only the efficacy of convalescent plasma, but also the volume of plasma needed if efficacy is proven. The study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. The same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Sham Comparator | Participants will receive the standard of care treatment |
|
| Group B | Active Comparator | Participants will receive the standard treatment and convalescent plasma in a volume of 200ml (150-300ml) |
|
| Group C | Active Comparator | Participants will receive the standard treatment and convalescent plasma in a volume of 400ml (300-600ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| convalescent plasma | Biological | The study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. The same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Time elapsed until clinical improvement or hospital discharge | clinical improvement is defined as the time from the randomization date until the decline of 2 categories on the ordinal scale of 10 categories or hospital discharge (whichever comes first) | Follow up until 28 days after transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| acute adverse events | incidence of acute adverse events possibly or definitively realted to convalescent plasma transfusion | Up to 12 hours after transfusion |
| Clinical Status | Evaluation according to an ordinal scale of 10 categories |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Esper G Kallás, PhD, MD | University of Sao Paulo General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo - General Hospital | São Paulo | São Paulo | 01403-002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35308034 | Derived | Song ATW, Rocha V, Mendrone-Junior A, Calado RT, De Santis GC, Benites BD, Costa-Lima C, Vargas T, Marques LS, Fernandes JC, Breda FC, Wendel S, Fachini R, Rizzo LV, Kutner JM, Avelino-Silva VI, Machado RRG, Durigon EL, Chevret S, Kallas EG. Treatment of severe COVID-19 patients with either low- or high-volume of convalescent plasma versus standard of care: A multicenter Bayesian randomized open-label clinical trial (COOP-COVID-19-MCTI). Lancet Reg Health Am. 2022 Jun;10:100216. doi: 10.1016/j.lana.2022.100216. Epub 2022 Mar 15. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2020 | Oct 22, 2021 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| Hospital Sirio-Libanes | OTHER |
| Hospital Israelita Albert Einstein | OTHER |
| Grupo Hospitalar Conceição | OTHER_GOV |
| Hospital Ernesto Dornelles | OTHER |
1:1:1 into 3 treatment groups: A- standard (control); B- standard and convalescent plasma in a volume of 200ml (150-300ml); C- standard and convalescent plasma in a volume of 400ml (300-600ml)
Not provided
Not provided
Not provided
Not provided
|
| "Day 7", "Day 14" and "Day 28" |
| Duration of clinical events | Duration of mechanical ventilation, length of hospital stay in survivors up to 28 days and time from the beginning of treatment to death | Up to 28 days |
| SARS-CoV-2 in nasopharyngeal swab | Detection of SARS-CoV-2 in nasopharyngeal swab | Days 0, 1, 3, 7, 14 and 28 after transfusion and control groups |
| IgG, IgM and IgA titers for SARS-CoV-2 | Specific IgG, IgM and IgA titers for SARS-CoV-2 | Days 0, 1, 3, 5, 7, 14 and 28 after transfusion and control groups |
| Neutralizing antibodies | Titers of neutralizing antibodies | 0,1,7 14 and 28 days after transfusion and control groups |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |