Clinical trial NCT04542967: Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease
Official title: Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe COVID-19 Disease
Keywords: SARS-CoV2
Convalescent Plasma
Severe Acute Respiratory Syndrome
Lead sponsor: Hospital Central Militar
Sponsor class: OTHER_GOV
First posted: 2020-09-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The PC-COVID-HCM clinical trial is a randomized, controlled, single-blind study .
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Disease progression
timeFrame: Up to 30 days later from study entry
measure: Side effects
timeFrame: Up to 30 days later from study entry
measure: Mortality
timeFrame: Up to 30 days later from study entry
Secondary outcomes:
measure: Respiratory improvement
timeFrame: 10 days
measure: Clinical improvement
timeFrame: 10 days
measure: Acute adverse events (AAE)
timeFrame: After receiving intervention, an average time one hour, until 24 hours after administration.
Other outcomes:
measure: Inflammatory biomarkers (D dimer)
timeFrame: 10 days
measure: Inflammatory biomarkers (Ferritin)
timeFrame: 10 days
measure: Inflammatory biomarkers (CPR)
timeFrame: 10 days
measure: Inflammatory biomarkers (LDH)
timeFrame: 10 days
Locations:
city: Mexico City
country: Mexico
facility: Hospital Central Militar
Study officials:
affiliation: Hospital Central Militar
name: Carmen G Torres, MD
role: PRINCIPAL_INVESTIGATOR
References: