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Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.
A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Our primary outcomes will be disease progression and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | They will receive the standard care for critically ill inpatients. | |
| Convalescent plasma group. | Experimental | They will receive standard care for patients with severe COVID-19 disease and convalescent plasma disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological | Biological | An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses. If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression | Change in ordinal Scale for Clinical Improvement (WHO). The progression disease, its the change in the severity score; a bigger number to the obtained after randomization | Up to 30 days later from study entry |
| Side effects | Side effects associated with the administration of convalescent plasma | Up to 30 days later from study entry |
| Mortality | Any cause of death | Up to 30 days later from study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory improvement | Change in partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio (PaO2/FiO2) | 10 days |
| Clinical improvement | Change in oxygen saturation levels |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory biomarkers (D dimer) | Change in pro-inflammatory biomarkers (D dimer μg/l) | 10 days |
| Inflammatory biomarkers (Ferritin) | Change in pro-inflammatory biomarkers ( Ferritin μg/L ) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen G Torres, MD | Hospital Central Militar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Central Militar | Mexico City | 11200 | Mexico |
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| Label | URL |
|---|---|
| Clinical Characteristics of Coronavirus Disease 2019 in China | View source |
| Potential interventions for novel coronavirus in China: A systematic review | View source |
| Use of convalescent plasma therapy in SARS patients in Hong Kong |
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Plan to make IPD still not decided and would need approval by regulatory authorities
From 6 months after publication
PRIOR APPLICATION
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
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The PC-COVID-HCM clinical trial is a randomized, controlled, single-blind study .
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The research was blinded as possible for the result's evaluators and those responsible for the statistical analysis. All patients admitted to the investigation were placed with a marker indicating that they were a patient of the plasma protocol, but not mention the study group. The data collectors and the outcome adjudicators were unaware of the treatment assignments.
|
| 10 days |
| Acute adverse events (AAE) | Transfusion reactions during transfusion. | After receiving intervention, an average time one hour, until 24 hours after administration. |
| 10 days |
| Inflammatory biomarkers (CPR) | Change in pro-inflammatory biomarkers, C-reactive protein ( CPR mg/L ) | 10 days |
| Inflammatory biomarkers (LDH) | Change in pro-inflammatory biomarkers, lactate dehydrogenase ( LDH UI/L) | 10 days |
| View source |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |