Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease

Phase 2

Completed

• Conditions: Severe COVID-19 Disease
• Interventions: Biological: Biological

• Registration Number: NCT04542967
• Lead Sponsor: Hospital Central Militar

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)

Study Timeline

• Study Start: 2020-06-23
• Status Verified: 2020-09
• Primary Completion: 2020-09-02
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Study Completion: 2020-09-30
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Convalescent plasma group.	Biological	They will receive standard care for patients with severe COVID-19 disease and convalescent plasma disease.

Primary Outcome Measures

Name	Time	Method
Side effects	Up to 30 days later from study entry	Side effects associated with the administration of convalescent plasma
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

Secondary Outcome Measures

Name	Time	Method
Acute adverse events (AAE)	After receiving intervention, an average time one hour, until 24 hours after administration.	Transfusion reactions during transfusion.
Respiratory improvement	10 days	Change in partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio (PaO2/FiO2)
Clinical improvement	10 days	Change in oxygen saturation levels

Trial Locations

Locations (1)

Hospital Central Militar; 🇲🇽 Mexico City, Mexico