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| ID | Type | Description | Link |
|---|---|---|---|
| 20997 | Registry Identifier | Peruvian Clinical Trial Registry (REPEC) |
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Open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with COVID-19 infection. This study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. Adults older than 18 years old, hospitalized with diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or life-threatening disease, will be included to the study after obtaining inform consent by the patient of a direct family member. Participants will be then randomized 1:1 to the experimental and the control groups.
Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of care. Participants at the control group will receive standard of care. Safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy.
The study protocol can be found in:
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care. |
|
| Control group | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent plasma | Biological | Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion-related Serious Adverse Events | Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2 | 14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause in-hospital mortality | Death during hospitalization within the first 30 days after enrollment | 30 days after randomization |
| Length of hospital stay | Number of days from date of enrollment to date of discharge |
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Inclusion Criteria:
Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation.
Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria:
Or critical disease with one or more of the following criteria:
Inform consent signed by patient or direct family member.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fiorella Krapp Lopez, MD, MSc | Universidad Peruana Cayetano Heredia | Principal Investigator |
| Patricia Garcia Funegra, MD, MSc | Universidad Peruana Cayetano Heredia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Cayetano Heredia | Lima | 15102 | Peru | |||
| Hospital Nacional Hipolito Unanue |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34001174 | Derived | Soto A, Krapp F, Vargas A, Cabrejos L, Argumanis E, Garcia PL, Altamirano K, Montes M, Chacon-Uscamaita PR, Garcia PJ. Randomized clinical trial to evaluate safety and efficacy of convalescent plasma use among hospitalized patients with COVID-19 (PERUCONPLASMA): a structured summary of a study protocol for a randomized controlled trial. Trials. 2021 May 17;22(1):342. doi: 10.1186/s13063-021-05189-6. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 30 days after randomization or until hospital discharge, whatever comes first |
| Length of ICU stay | Number of days from date of admission to the ICU to date of discharge from ICU | 30 days after randomization or until hospital discharge, whatever comes first |
| Need of invasive mechanical ventilation | Requirement of invasive mechanical ventilation (Yes/No). Evaluated only for those participants that were on non-invasive ventilatory support at time of randomization | 30 days after randomization or until hospital discharge, whatever comes first |
| Duration of mechanical ventilation | Number of days from date of intubation to date of successful extubation | 30 days after randomization or until hospital discharge, whatever comes first |
| Clinical Improvement at 14 days | Improvement of 2 or more points in the WHO progression scale | At 3, 14 and 30 days after randomization |
| Lima |
| Peru |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |