Severe COVID-19 Disease
Conditions
Keywords
SARS-CoV2, Convalescent Plasma, Severe Acute Respiratory Syndrome
Brief summary
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.
Detailed description
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)
Interventions
BIOLOGICALBiological
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.
Sponsors
Hospital Central Militar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
The PC-COVID-HCM clinical trial is a randomized, controlled, single-blind study .
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* O2 saturation \<93% * Radiographic evidence of moderate pneumonia according to Rale's classification. * Acute respiratory distress syndrome (PaO2 / FiO2 \<300 or SpO2 / FiO2 ≤ 315) * Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated)
Exclusion criteria
* Pregnant patients * History of transfusion reactions * Patients with congestive heart failure * Patients with a history of chronic kidney failure on dialysis * Patients with multiple organ failure * Patients who does not accept or agree with the treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression | Up to 30 days later from study entry | 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 |
| Mortality | Up to 30 days later from study entry | Any cause of death |
| Side effects | Up to 30 days later from study entry | Side effects associated with the administration of convalescent plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement | 10 days | Change in oxygen saturation levels |
| Respiratory improvement | 10 days | Change in partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio (PaO2/FiO2) |
| Acute adverse events (AAE) | After receiving intervention, an average time one hour, until 24 hours after administration. | Transfusion reactions during transfusion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory biomarkers (Ferritin) | 10 days | Change in pro-inflammatory biomarkers ( Ferritin μg/L ) |
| Inflammatory biomarkers (LDH) | 10 days | Change in pro-inflammatory biomarkers, lactate dehydrogenase ( LDH UI/L) |
| Inflammatory biomarkers (CPR) | 10 days | Change in pro-inflammatory biomarkers, C-reactive protein ( CPR mg/L ) |
| Inflammatory biomarkers (D dimer) | 10 days | Change in pro-inflammatory biomarkers (D dimer μg/l) |
Countries
Mexico
Outcome results
None listed